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2 Drug misuse

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4 Psychosocial management of

5 drug misuse

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8 National Clinical Practice Guideline Number X 9

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11 National Collaborating Centre for Mental Health 12 Commissioned by the 13 National Institute for Health and Clinical 14 Excellence 15

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1 Guideline Development Group Members

2 Professor John Strang (Chair, Guideline Development Group) 3 Professor of Psychiatry of Addictions 4 Director – National Addiction Centre, Institute of Psychiatry 5 Honorary Consultant Psychiatrist, South London and Maudsley NHS Trust 6 7 Mr Stephen Pilling (Facilitator, Guideline Development Group) 8 Joint Director, The National Collaborating Centre for Mental Health 9 Director, Centre for Outcomes, Research and Effectiveness, University College 10 London 11 Consultant Clinical Psychologist, Camden and Islington Mental Health and 12 Social Care Trust 13 14 Dr Eliot Ross Albert 15 Service-user representative 16 17 Ms Janet Brotchie 18 Clinical Psychology Advisor, Quality Team, National Treatment Agency for 19 Substance Misuse 20 Lead Psychologist, Central and North West London Mental Health NHS Trust 21 Substance Misuse Service 22 23 Dr Alex Copello 24 Clinical Director, Substance Misuse Services and Addictions Research and 25 Development Programme Director, Birmingham and Solihull Mental Health 26 NHS Trust 27 Senior Lecturer in Clinical Psychology, University of Birmingham 28 29 Professor Colin Drummond 30 Professor of Addiction Psychiatry, St George’s Hospital Medical School, 31 University of London; Honorary Consultant Psychiatrist, South West London 32 and St George’s NHS Trust 33 34 Mr Mark Gilman 35 North West Regional Manager, National Treatment Agency for Substance 36 Misuse 37 38 Ms Sarah Hopkins 39 Project Manager, The National Collaborating Centre for Mental Health (2006– 40 2007) 41 42 Dr Christopher Jones 43 Health Economist, The National Collaborating Centre for Mental Health (until 44 2006) 45 46 Ms Rebecca King

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1 Project Manager, The National Collaborating Centre for Mental Health (2005– 2 2006) 3 4 Mr Tim Leighton 5 Head of Professional Education, Training and Research, Clouds 6 Director of Studies, University of Bath Foundation Degree and BSc (Hons) in 7 Addictions Counselling 8 9 Mr Ryan Li 10 Research Assistant, The National Collaborating Centre for Mental Health 11 12 Dr Ifigeneia Mavranezouli 13 Senior Health Economist, The National Collaborating Centre for Mental 14 Health 15 16 Mr Peter McDermott 17 Service-user representative 18 19 Dr Nicholas Meader 20 Systematic Reviewer, The National Collaborating Centre for Mental Health 21 22 Ms Poonam Sood 23 Research Assistant, The National Collaborating Centre for Mental Health 24 25 Ms Sarah Stockton 26 Information Scientist, The National Collaborating Centre for Mental Health 27 28 Mr Andy Stopher 29 Borough Services Assistant Director (Camden), Substance Misuse Services 30 31 Dr Clare Taylor 32 Editor, The National Collaborating Centre for Mental Health 33 34 Mr Ian Wardle 35 Chief Executive, Lifeline Project, Manchester 36 37 Mrs Tina Williams 38 Carer representative 39 Chief Executive for The Bridge Project carer service and PANIC user service 40 41 Dr Nat Wright 42 Clinical Director for Substance Misuse, HMP Leeds, Leeds Primary Care Trust

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1 Table of contents

2 Guideline Development Group Members ...... 2

3 1 Executive summary...... 7

4 2 Introduction ...... 8 5 2.1 National guidelines...... 8 6 2.2 The national psychosocial management of drug misuse guideline ...... 11

7 3 Methods used to develop this guideline...... 14 8 3.1 Overview...... 14 9 3.2 The Scope ...... 14 10 3.3 The Guideline Development Group ...... 15 11 3.4 Clinical questions...... 17 12 3.5 Systematic clinical literature review...... 18 13 3.6 Health economics review strategies...... 30 14 3.7 Stakeholder contributions ...... 34 15 3.8 Validation of this guideline...... 34

16 4 Introduction to drug misuse ...... 35 17 4.1 Drug misuse...... 35 18 4.2 Epidemiology...... 38 19 4.3 Aetiology and maintenance of drug misuse...... 39 20 4.4 The course of drug misuse...... 40 21 4.5 The pharmacological effects of drug misuse ...... 41 22 4.6 The public health impact of drug misuse ...... 43 23 4.7 Identification and assessment of drug misuse...... 44 24 4.8 The aims of the treatment and management of drug misuse ...... 45 25 4.9 Current care and treatment in the NHS...... 47 26 4.10 Service-user organisations ...... 50 27 4.11 Economic impact of drug misuse ...... 51 28 4.12 Clinical practice recommendations ...... 52

29 5 Service-user involvement and experience, and impact on carers ...... 53 30 5.1 Introduction ...... 53 31 5.2 Historical perspectives of service-user involvement ...... 53 32 5.3 Service-user experience of services...... 59 33 5.4 Impact of drug misuse on carers ...... 67

34 6 Identification and recognition...... 71

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1 6.1 Introduction ...... 71 2 6.2 Identification tools ...... 73

3 7 Brief interventions and reduction of injection and sexual risk behaviours.... 78 4 7.1 Introduction ...... 78 5 7.2 Brief interventions ...... 78 6 7.3 Psychosocial interventions to improve compliance with physical healthcare ...... 86 7 7.4 Psychosocial interventions to reduce injecting and sexual risk behaviours ...... 91

8 8 Psychological interventions...... 100 9 8.1 Introduction ...... 100 10 8.3 Psychological interventions alone for the management of drug misuse (cocaine, 11 cannabis and opiates) ...... 103 12 8.4 Psychological interventions in combination with opiate agonist maintenance 13 treatment...... 114 14 8.5 Psychological interventions in combination with naltrexone maintenance 15 treatment...... 134 16 8.6 Self-help groups...... 137 17 8.7 Co-ordination of care and case management...... 142 18 8.8 Multi-modal care programmes...... 146

19 9 Residential, prison and inpatient care...... 154 20 9.1 Introduction ...... 154 21 9.2 Inpatient settings ...... 155 22 9.3 Residential settings...... 156 23 9.4 Legally mandated treatment interventions...... 165 24 9.5 Prison...... 166

25 10 Appendices (appendices 14, 15 and 16 supplied as separate files on the website) .... 171

26 11 References ...... 220

27 12 Abbreviations ...... 253

28 13 Glossary ...... 257 29

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1 Acknowledgements 2 3 The psychosocial management of drug misuse Guideline Development Group 4 and the National Collaborating Centre for Mental Health (NCCMH) review 5 team would like to thank the following people: 6 7 Those who acted as advisers on specialist topics or have contributed to the 8 process by meeting with the Guideline Development Group:

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1 1 Executive summary

2 3 (Summary recommendations [NICE guideline] to be inserted after 4 consultation.)

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1 2 Introduction

2 This guideline has been developed to advise on the psychosocial management 3 of drug misuse. The guideline recommendations have been developed by a 4 multidisciplinary team of healthcare professionals, service users, a carer and 5 guideline methodologists after careful consideration of the best available 6 evidence. It is intended that the guideline will be useful to clinicians and 7 service commissioners in providing and planning high-quality care for people 8 who misuse drugs while also emphasising the importance of the experience of 9 care for people who misuse drugs and their carers.

10 Although the evidence base is rapidly expanding, there are a number of major 11 gaps, and future revisions of this guideline will incorporate new scientific 12 evidence as it develops. The guideline makes a number of research 13 recommendations specifically to address gaps in the evidence base. In the 14 meantime, it is hoped that the guideline will assist clinicians, people who 15 misuse drugs and their carers by identifying the merits of particular treatment 16 approaches where the evidence from research and clinical experience exists.

17 2.1 National guidelines

18 2.1.1 What are clinical practice guidelines? 19 Clinical practice guidelines are ‘systematically developed statements that 20 assist clinicians and patients in making decisions about appropriate treatment 21 for specific conditions’ (Mann, 1996). They are derived from the best available 22 research evidence, using predetermined and systematic methods to identify 23 and evaluate the evidence relating to the specific condition in question. Where 24 evidence is lacking, the guidelines incorporate statements and 25 recommendations based upon the consensus statements developed by the 26 Guideline Development Group (GDG).

27 Clinical guidelines are intended to improve the process and outcomes of 28 healthcare in a number of different ways. They can:

29 • provide up-to-date evidence-based recommendations for the 30 management of conditions and disorders by healthcare 31 professionals

32 • be used as the basis to set standards to assess the practice of 33 healthcare professionals

34 • form the basis for education and training of healthcare 35 professionals

36 • assist patients and carers in making informed decisions about their 37 treatment and care

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1 • improve communication between healthcare professionals, patients 2 and carers

3 • help identify priority areas for further research. 4

5 2.1.2 Uses and limitations of clinical guidelines 6 Guidelines are not a substitute for professional knowledge and clinical 7 judgement. They can be limited in their usefulness and applicability by a 8 number of different factors: the availability of high-quality research evidence, 9 the quality of the methodology used in the development of the guideline, the 10 generalisability of research findings and the uniqueness of individuals who 11 misuse drugs.

12 Although the quality of research in this field is variable, the methodology 13 used here reflects current international understanding on the appropriate 14 practice for guideline development (AGREE: Appraisal of Guidelines for 15 Research and Evaluation Instrument; www.agreecollaboration.org), ensuring 16 the collection and selection of the best research evidence available and the 17 systematic generation of treatment recommendations applicable to the 18 majority of people with these disorders and situations. However, there will 19 always be some people and situations for which clinical guideline 20 recommendations are not readily applicable. This guideline does not, 21 therefore, override the individual responsibility of healthcare professionals to 22 make appropriate decisions in the circumstances of the individual, in 23 consultation with the person who misuses drugs/or carer.

24 In addition to the clinical evidence, cost-effectiveness information, where 25 available, is taken into account in the generation of statements and 26 recommendations of the clinical guidelines. While national guidelines are 27 concerned with clinical and cost effectiveness, issues of affordability and 28 implementation costs are to be determined by the NHS.

29 In using guidelines, it is important to remember that the absence of empirical 30 evidence for the effectiveness of a particular intervention is not the same as 31 evidence for ineffectiveness. In addition, of particular relevance in mental 32 health, evidence-based treatments are often delivered within the context of an 33 overall treatment programme including a range of activities, the purpose of 34 which may be to help engage the person and to provide an appropriate 35 context for the delivery of specific interventions. It is important to maintain 36 and enhance the service context in which these interventions are delivered; 37 otherwise the specific benefits of effective interventions will be lost. Indeed, 38 the importance of organising care in order to support and encourage a good 39 therapeutic relationship is at times as important as the specific treatments 40 offered.

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1 2.1.3 Why develop national guidelines? 2 The National Institute for Health and Clinical Excellence (NICE) was 3 established as a Special Health Authority for England and Wales in 1999, with 4 a remit to provide a single source of authoritative and reliable guidance for 5 patients, professionals and the public. NICE guidance aims to improve 6 standards of care, to diminish unacceptable variations in the provision and 7 quality of care across the NHS and to ensure that the health service is patient 8 centred. All guidance is developed in a transparent and collaborative manner 9 using the best available evidence and involving all relevant stakeholders.

10 NICE generates guidance in a number of different ways, three of which are 11 relevant here. First, national guidance is produced by the Technology 12 Appraisal Committee to give robust advice about a particular treatment, 13 intervention, procedure or other health technology. Second, NICE 14 commissions public health intervention guidance focused on types of activity 15 (interventions) that help to reduce people’s risk of developing a disease or 16 condition or help to promote or maintain a healthy lifestyle. Third, NICE 17 commissions the production of national clinical practice guidelines focused 18 upon the overall treatment and management of a specific condition. To enable 19 this latter development, NICE has established seven National Collaborating 20 Centres in conjunction with a range of professional organisations involved in 21 healthcare.

22 2.1.4 The National Collaborating Centre for Mental Health 23 This guideline has been commissioned by NICE and developed within the 24 National Collaborating Centre for Mental Health (NCCMH). The NCCMH is 25 a collaboration of the professional organisations involved in the field of 26 mental health, national patient and carer organisations, a number of academic 27 institutions and NICE. The NCCMH is funded by NICE and is led by a 28 partnership between the Royal College of Psychiatrists’ research unit (College 29 Research and Training Unit – CRTU) and the British Psychological Society’s 30 equivalent unit (Centre for Outcomes Research and Effectiveness – CORE).

31 2.1.5 From national guidelines to local protocols 32 Once a national guideline has been published and disseminated, local 33 healthcare groups will be expected to produce a plan and identify resources 34 for implementation, along with appropriate timetables. Subsequently, a 35 multidisciplinary group involving commissioners of healthcare, primary care 36 and specialist mental health professionals, patients and carers should 37 undertake the translation of the implementation plan into local protocols 38 taking into account both the recommendations set out in this guideline and 39 the priorities set in the National Service Framework for Mental Health and 40 related documentation. The nature and pace of the local plan will reflect local 41 healthcare needs and the nature of existing services; full implementation may 42 take a considerable time, especially where substantial training needs are 43 identified.

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1 2.1.6 Auditing the implementation of guidelines 2 This guideline identifies key areas of clinical practice and service delivery for 3 local and national audit. Although the generation of audit standards is an 4 important and necessary step in the implementation of this guidance, a more 5 broadly based implementation strategy will be developed. Nevertheless, it 6 should be noted that the Healthcare Commission will monitor the extent to 7 which Primary Care Trusts (PCTs), trusts responsible for mental health and 8 social care and Health Authorities have implemented these guidelines.

9 2.2 The national psychosocial management of drug misuse guideline

10 2.2.1 Who has developed this guideline? 11 The Guideline Development Group (GDG) was convened by the NCCMH 12 and supported by funding from NICE. The GDG included two service users 13 and a carer, and professionals from psychiatry, clinical psychology, general 14 practice, the Prison Service, the National Treatment Agency for Substance 15 Misuse and the private and voluntary sectors.

16 Staff from the NCCMH provided leadership and support throughout the 17 process of guideline development, undertaking systematic searches, 18 information retrieval, appraisal and systematic review of the evidence. 19 Members of the GDG received training in the process of guideline 20 development from NCCMH staff and the service users and carer received 21 training and support from the NICE Patient and Public Involvement 22 Programme. The NICE Guidelines Technical Adviser provided advice and 23 assistance regarding aspects of the guideline development process.

24 All GDG members made formal declarations of interest at the outset, which 25 were updated at every GDG meeting. The GDG met a total of nine times 26 throughout the process of guideline development. It met as a whole, but key 27 topics were led by a national expert in the relevant topic. The GDG was 28 supported by the NCCMH technical team, with additional expert advice from 29 special advisers where needed. The group oversaw the production and 30 synthesis of research evidence before presentation. All statements and 31 recommendations in this guideline have been generated and agreed by the 32 whole GDG.

33 2.2.2 For whom is this guideline intended? 34 This guideline will be relevant for adults and young people who misuse 35 drugs.

36 The guideline covers the care provided by primary, community, secondary, 37 tertiary and other healthcare professionals who have direct contact with, and 38 make decisions concerning the care of, adults and young people who misuse 39 drugs.

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1 The guideline will also be relevant to the work, but will not cover the practice, 2 of those in: 3 • occupational health services

4 • social services

5 • the independent sector.

6 The experience of drug misuse can affect the whole family and often the 7 community. The guideline recognises the role of both in the treatment and 8 support of people who misuse drugs. 9

10 2.2.3 Specific aims of this guideline 11 The guideline makes recommendations for the psychosocial management of 12 drug misuse. Specifically, it aims to:

13 • evaluate the role of specific psychosocial interventions in the 14 treatment of drug misuse

15 • evaluate the role of specific psychosocial interventions in 16 combination with pharmacological interventions in the treatment of 17 drug misuse

18 • integrate the above to provide best-practice advice on the care of 19 individuals throughout the course of their drug misuse

20 • promote the implementation of best clinical practice through the 21 development of recommendations tailored to the requirements of 22 the NHS in England and Wales.

23 2.2.4 The structure of this guideline 24 The guideline is divided into chapters, each covering a set of related topics. 25 The first three chapters provide a summary of the clinical practice and 26 research recommendations and a general introduction to guidelines and to the 27 methods used to develop them. The fourth chapter provides an introduction 28 to the drug misuse topic. Chapters 4 to 9 provide the evidence that underpins 29 the recommendations. 30 31 Each evidence chapter begins with a general introduction to the topic that sets 32 the recommendations in context. Depending on the nature of the evidence, 33 narrative reviews or meta-analyses were conducted. Therefore, the structure 34 of the chapters varies. Where appropriate, details about current practice, the 35 evidence base and any research limitations are provided. Where meta- 36 analyses were conducted, information is given about both the interventions 37 included and the studies considered for review. Clinical summaries are then 38 used to summarise the evidence presented. Finally, recommendations related

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1 to each topic are presented at the end of each chapter. On the CD-ROM, full 2 details about the included studies can be found in Appendix 16. Where meta- 3 analyses were conducted, the data are presented using forest plots in 4 Appendix 17 (see Text Box 1 for details). 5 6 Text Box 1: Appendices on CD-ROM Content Appendix

Included/ excluded studies Appendix 14

Forest plots Appendix 15

GRADE evidence profiles Appendix 16 7

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1 3 Methods used to develop this 2 guideline

3 3.1 Overview 4 The development of this guideline drew upon methods outlined by NICE (The 5 Guidelines Manual1 [NICE, 2006]). A team of health professionals, lay 6 representatives and technical experts known as the Guideline Development 7 Group (GDG), with support from the NCCMH staff, undertook the 8 development of a patient-centred, evidence-based guideline. There are six 9 basic steps in the process of developing a guideline: 10 11 • Define the scope, which sets the parameters of the guideline and 12 provides a focus and steer for the development work.

13 • Define clinical questions considered important for practitioners and 14 service users.

15 • Develop criteria for evidence searching and search for evidence.

16 • Design validated protocols for systematic review and apply to 17 evidence recovered by search.

18 • Synthesise and (meta-) analyse data retrieved, guided by the clinical 19 questions, and produce evidence profiles.

20 • Answer clinical questions with evidence-based recommendations 21 for clinical practice.

22 The clinical practice recommendations made by the GDG are therefore 23 derived from the most up-to-date and robust evidence base for the clinical 24 and cost effectiveness of psychosocial interventions for people who misuse 25 drugs. In addition, to ensure a service user and carer focus, the concerns of 26 service users and carers regarding health and social care have been 27 highlighted and addressed by recommendations agreed by the whole GDG.

28 3.2 The Scope 29 Guideline topics are selected by the Department of Health and the Welsh 30 Assembly Government, which identify the main areas to be covered by the 31 guideline in a specific remit (see The Guideline Development Process – An

1 Available from: www.nice.org.uk

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1 Overview for Stakeholders, the Public and the NHS (second edition)2). The remit for 2 this guideline was translated into a scope document by staff at the NCCMH. 3 4 The purpose of the scope was to: 5 • provide an overview of what the guideline will include and exclude

6 • identify the key aspects of care that must be included

7 • set the boundaries of the development work and provide a clear 8 framework to enable work to stay within the priorities agreed by 9 NICE and the NCC and the remit from the Department of 10 Health/Welsh Assembly Government

11 • inform the development of the clinical questions and search 12 strategy

13 • inform professionals and the public about the expected content of 14 the guideline

15 • keep the guideline to a reasonable size to ensure that its 16 development can be carried out within a 12-month period.

17 The draft scope was subject to consultation with stakeholders over a 4-week 18 period. During the consultation period, the scope was posted on the NICE 19 website (www.nice.org.uk). Comments were invited from stakeholder 20 organisations and Guideline Review Panel (GRP). Further information about 21 the GRP can also be found on the NICE website. The NCCMH and NICE 22 reviewed the scope in light of comments received, and the revised scope was 23 signed off by the GRP.

24 3.3 The Guideline Development Group 25 The GDG consisted of: two service users and a carer, and professionals from 26 psychiatry, clinical psychology, general practice, the Prison Service, the 27 National Treatment Agency for Substance Misuse and the private and 28 voluntary sectors. The guideline development process was supported by staff 29 from the NCCMH, who undertook the clinical and health economics literature 30 searches, reviewed and presented the evidence to the GDG, managed the 31 process and contributed to drafting the guideline.

32 3.3.1 Guideline Development Group meetings 33 Nine GDG meetings were held between November 2005 and February 2007. 34 During each day-long GDG meeting, in a plenary session, clinical questions 35 and clinical and economic evidence were reviewed and assessed, and

2 National Institute for Health and Clinical Excellence (September 2006) The Guideline Development Process – An Overview for Stakeholders, the Public and the NHS (second edition). London: National Institute for Health and Clinical Excellence. Available from: www.nice.org.uk

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1 recommendations formulated. At each meeting, all GDG members declared 2 any potential conflicts of interest, and service user and carer concerns were 3 routinely discussed as part of a standing agenda.

4 3.3.2 Topic groups 5 The GDG divided its workload along clinically relevant lines to simplify the 6 guideline development process, and GDG members formed smaller topic 7 groups to undertake guideline work in that area of clinical practice. Topic 8 Group 1 covered questions relating to identification and recognition. Topic 9 Group 2 covered brief interventions and the reduction of injection and sexual 10 risk behaviours, Topic Group 3 covered formal psychological interventions 11 and Topic Group 4 covered inpatient and prison settings. These groups were 12 designed to efficiently manage the large volume of evidence appraisal prior to 13 presenting it to the GDG as a whole. Each topic group was chaired by a GDG 14 member with expert knowledge of the topic area (one of the healthcare 15 professionals). Topic groups refined the clinical questions, refined the clinical 16 definitions of treatment interventions, reviewed and prepared the evidence 17 with the systematic reviewer before presenting it to the GDG as a whole and 18 helped the GDG to identify further expertise in the topic. Topic group leaders 19 reported the status of the group’s work as part of the standing agenda. They 20 also introduced and led the GDG discussion of the evidence review for that 21 topic and assisted the GDG Chair in drafting the section of the guideline 22 relevant to the work of each topic group.

23 3.3.3 Service users and carers 24 Individuals with direct experience of services gave an integral service-user 25 focus to the GDG and the guideline. The GDG included two service users and 26 a carer. They contributed as full GDG members to writing the clinical 27 questions, helping to ensure that the evidence addressed their views and 28 preferences, highlighting sensitive issues and terminology relevant to the 29 guideline, and bringing service-user research to the attention of the GDG. In 30 drafting the guideline, they contributed to writing the guideline’s 31 introduction and identified recommendations from the service user and carer 32 perspective.

33 3.3.4 Special advisors 34 Special advisors, who had specific expertise in one or more aspects of 35 treatment and management relevant to the guideline, assisted the GDG, 36 commenting on specific aspects of the developing guideline and making 37 presentations to the GDG. Appendix 2 lists those who agreed to act as special 38 advisors.

39 3.3.5 National and international experts 40 National and international experts in the area under review were identified 41 through the literature search and through the experience of the GDG 42 members. These experts were contacted to recommend unpublished or soon-

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1 to-be published studies in order to ensure up-to-date evidence was included 2 in the development of the guideline. They informed the group about 3 completed trials at the pre-publication stage, systematic reviews in the 4 process of being published, studies relating to the cost effectiveness of 5 treatment and trial data if the GDG could be provided with full access to the 6 complete trial report. Appendix 5 lists researchers who were contacted.

7 3.4 Clinical questions 8 Clinical questions were used to guide the identification and interrogation of 9 the evidence base relevant to the topic of the guideline. Before the first GDG 10 meeting, draft questions were prepared by NCCMH staff based on the scope 11 and an overview of existing guidelines. They were then discussed by the GDG 12 at their first two meetings and amended as necessary. Where appropriate, the 13 questions were refined once the evidence had been searched and, where 14 necessary, sub-questions were generated. The final list of clinical questions 15 can be found in Appendix 6. 16 17 For questions about interventions, the PICO (patient, intervention, 18 comparison and outcome) framework was used. This structured approach 19 divides each question into four components: the patients (the population 20 under study), the interventions (what is being done), the comparisons (other 21 main treatment options) and the outcomes (the measures of how effective the 22 interventions have been) (see Text Box 2). 23 24 Text Box 2: Features of a well-formulated question on effectiveness intervention — 25 the PICO guide

Patients/ population Which patients or population of patients are we interested in? How can they be best described? Are there subgroups that need to be considered?

Intervention Which intervention, treatment or approach should be used?

Comparison What is/are the main alternative/s to compare with the intervention?

Outcome What is really important for the patient? Which outcomes should be considered: intermediate or short-term measures; mortality; morbidity and treatment complications; rates of relapse; late morbidity and readmission; return to work, physical and social functioning and other measures such as quality of life; general health status; costs? 26 27 Questions relating to diagnosis do not involve an intervention designed to 28 treat a particular condition, therefore the PICO framework was not used. 29 Rather, the questions were designed to pick up key issues specifically relevant 30 to diagnostic tests, for example their accuracy, reliability, safety and 31 acceptability to the patient.

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1 2 In some situations, the prognosis of a particular condition is of fundamental 3 importance, over and above its general significance in relation to specific 4 interventions. Areas where this is particularly likely to occur relate to 5 assessment of risk, for example in terms of behaviour modification or 6 screening and early intervention. In addition, questions related to issues of 7 service delivery are occasionally specified in the remit from the Department 8 of Health (DH)/Welsh Assembly Government. In these cases, appropriate 9 clinical questions were developed to be clear and concise. 10 11 To help facilitate the literature review, a note was made of the best study 12 design type to answer each question. There are four main types of clinical 13 question of relevance to NICE guidelines. These are listed in Text Box 3. For 14 each type of question, the best primary study design varies, where ‘best’ is 15 interpreted as ‘least likely to give misleading answers to the question’. 16 17 However, in all cases, a well-conducted systematic review of the appropriate 18 type of study is likely to always yield a better answer than a single study. 19 20 Deciding on the best design type to answer a specific clinical or public health 21 question does not mean that studies of different design types addressing the 22 same question were discarded. 23 24 Text Box 3: Best study design to answer each type of question Type of question Best primary study design

Effectiveness or other impact of an Randomised controlled trial; other studies that intervention may be considered in the absence of an RCT are the following: internally / externally controlled before and after trial, interrupted time-series

Accuracy of information (e.g. risk factor, Comparing the information against a valid gold test, prediction rule) standard in a randomised trial or inception cohort study

Rates (of disease, patient experience, rare Cohort, registry, cross-sectional study side effects) Costs Naturalistic prospective cost study

25

26 3.5 Systematic clinical literature review 27 The aim of the clinical literature review was to systematically identify and 28 synthesise relevant evidence from the literature in order to answer the specific 29 clinical questions developed by the GDG. Thus, clinical practice 30 recommendations are evidence based, where possible, and, if evidence is not 31 available, informal consensus methods are used (see Section 3.5.6) and the 32 need for future research is specified.

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1 3.5.1 Methodology 2 A stepwise, hierarchical approach was taken to locating and presenting 3 evidence to the GDG. The NCCMH developed this process based on methods 4 set out in The Guidelines Manual3 and after considering recommendations from 5 a range of other sources. These included: 6 • Clinical Policy and Practice Program of the New South Wales 7 Department of Health

8 • Clinical Evidence online

9 • The Cochrane Collaboration

10 • New Zealand Guidelines Group

11 • NHS Centre for Reviews and Dissemination

12 • Oxford Centre for Evidence-Based Medicine

13 • Scottish Intercollegiate Guidelines Network (SIGN)

14 • United States Agency for Healthcare Research and Quality

15 • Oxford Systematic Review Development Programme

16 • Grading of Recommendations: Assessment, Development and 17 Evaluation (GRADE) Working Group.

18 3.5.2 The review process 19 After the scope was finalised, a more extensive search for systematic reviews 20 and published guidelines was undertaken. Existing NICE guidelines were 21 updated where necessary. Other relevant guidelines were assessed for quality 22 using the AGREE instrument (AGREE Collaboration, 2003). The evidence 23 base underlying high-quality existing guidelines was utilised and updated as 24 appropriate. 25 26 At this point, the review team, in conjunction with the GDG, developed a 27 review protocol that detailed all comparisons necessary to answer the clinical 28 questions. The initial approach taken to locating primary-level studies 29 depended on the type of clinical question and availability of evidence. 30 31 The GDG decided which questions were best addressed by good practice 32 based on expert opinion, which questions were likely to have a good evidence 33 base and which questions were likely to have little or no directly relevant 34 evidence. Recommendations based on good practice were developed by

3 National Institute for Health and Clinical Excellence (April 2006) The Guidelines Manual. London: National Institute for Health and Clinical Excellence. Available from: www.nice.org.uk

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1 informal consensus of the GDG. For questions with a good evidence base, the 2 review process depended on the type of key question (see below). For 3 questions that were unlikely to have a good evidence base, a brief descriptive 4 review was initially undertaken by a member of the GDG. 5 6 Searches for evidence were updated 6–8 weeks before the stakeholder 7 consultation. After this point, studies were included only if they were judged 8 by the GDG to be exceptional (for example, the evidence was likely to change 9 a recommendation). 10 11 The search process for questions concerning interventions 12 13 For questions related to interventions, the initial evidence base was formed 14 from well-conducted randomised controlled trials (RCTs) that addressed at 15 least one of the clinical questions. Although there are a number of difficulties 16 with the use of RCTs in the evaluation of interventions in mental health, the 17 RCT remains the most important method for establishing treatment efficacy 18 (this is discussed in more detail in appropriate clinical evidence chapters). For 19 other clinical questions, searches were for the appropriate study design. 20 21 All searches were based on the standard mental health related bibliographic 22 databases (EMBASE, MEDLINE, PsycINFO, Cochrane Library, CINAHL) for 23 all trials potentially relevant to the guideline. 24 25 Where the evidence base was large, recent high-quality English-language 26 systematic reviews were used primarily as a source of RCTs (see Appendix 10 27 for quality criteria used to assess systematic reviews). However, in some 28 circumstances existing data sets were utilised. Where this was the case, data 29 were cross-checked for accuracy before use. New RCTs meeting inclusion 30 criteria set by the GDG were incorporated into the existing reviews and fresh 31 analyses performed. 32 33 After the initial search results were scanned liberally to exclude irrelevant 34 papers, the review team used a purpose-built ‘study information’ database to 35 manage both the included and the excluded studies (eligibility criteria were 36 developed after consultation with the GDG). For questions without good- 37 quality evidence (after the initial search), a decision was made by the GDG 38 about whether to (a) repeat the search using subject-specific databases (for 39 example, AMED, SIGLE or PILOTS), (b) conduct a new search for lower levels 40 of evidence or (c) adopt a consensus process (see Section 3.5.6). Future 41 guidelines will be able to update and extend the usable evidence base starting 42 from the evidence collected, synthesised and analysed for this guideline. 43 44 In addition, searches were made of the reference lists of all eligible systematic 45 reviews and included studies, as well as the list of evidence submitted by 46 stakeholders. Known experts in the field (see Appendix 5), based both on the

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1 references identified in early steps and on advice from GDG members, were 2 sent letters requesting relevant studies that were in the process of being 3 published4. In addition, the tables of contents of appropriate journals were 4 periodically checked for relevant studies. 5 6 The search process for questions of diagnosis and prognosis 7 8 For questions related to diagnosis and prognosis, the search process was the 9 same as described above, except that the initial evidence base was formed 10 from studies with the most appropriate and reliable design to answer the 11 particular question. That is, for questions about diagnosis, the initial search 12 was for cross-sectional studies; for questions about prognosis, it was for 13 cohort studies of representative patients. In situations where it was not 14 possible to identify a substantial body of appropriately designed studies that 15 directly addressed each clinical question, a consensus process was adopted 16 (see Section 3.5.6). 17 18 Search filters 19 20 Search filters developed by the review team consisted of a combination of 21 subject heading and free-text phrases. Specific filters were developed for the 22 guideline topic and, where necessary, for each clinical question. In addition, 23 the review team used filters developed for systematic reviews, RCTs and 24 other appropriate research designs (Appendix 8). 25 26 Study selection 27 28 All primary-level studies included after the first scan of citations were 29 acquired in full and re-evaluated for eligibility at the time they were being 30 entered into the study information database. Eligibility criteria were 31 developed for each clinical question and are described in the relevant clinical 32 evidence chapters. Eligible systematic reviews and primary-level studies were 33 critically appraised for methodological quality (see Appendix 10 and 34 Appendix 15 [the characteristics of included studies table]). The eligibility of 35 each study was confirmed by at least one member of the appropriate topic 36 group. 37 38 For some clinical questions, it was necessary to prioritise the evidence with 39 respect to the UK context (that is, external validity). To make this process 40 explicit, the topic groups took into account the following factors when 41 assessing the evidence: 42 • participant factors (for example, gender, age and ethnicity)

4 Unpublished full trial reports were also accepted where sufficient information was available to judge eligibility and quality (see section on unpublished evidence).

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1 • provider factors (for example, model fidelity, the conditions under 2 which the intervention was performed and the availability of 3 experienced staff to undertake the procedure)

4 • cultural factors (for example, differences in standard care and 5 differences in the welfare system).

6 It was the responsibility of each topic group to decide which prioritisation 7 factors were relevant to each clinical question in light of the UK context and 8 then decide how they should modify their recommendations. 9 10 Unpublished evidence 11 12 The GDG used a number of criteria when deciding whether or not to accept 13 unpublished data. First, the evidence must have been accompanied by a trial 14 report containing sufficient detail to properly assess the quality of the data. 15 Second, the evidence must have been submitted with the understanding that 16 data from the study and a summary of the study’s characteristics would be 17 published in the full guideline. Therefore, the GDG did not accept evidence 18 submitted as commercial in confidence. However, the GDG recognised that 19 unpublished evidence submitted by investigators might later be retracted by 20 those investigators if the inclusion of such data would jeopardise publication 21 of their research.

22 3.5.3 Data extraction and synthesising the evidence 23 24 Outcome data were extracted from all eligible studies, which met the quality 25 criteria. Where possible, meta-analysis was used to synthesise the evidence 26 using Review Manager 4.2.8 (Cochrane Collaboration, 2005). If necessary, 27 reanalyses of the data or sub-analyses were used to answer clinical questions 28 not addressed in the original studies or reviews. 29 30 Where possible, dichotomous efficacy outcomes were calculated on an 31 intention-to-treat basis (that is, a ‛once-randomised-always-analyse’ basis). 32 This assumes that those participants who ceased to engage in the study – from 33 whatever group – had an unfavourable outcome. Adverse effects were 34 entered into Review Manager as reported by the study authors because it was 35 usually not possible to determine whether early withdrawals had an 36 unfavourable outcome. For the outcome ‘leaving the study early for any 37 reason’, the denominator was the number randomised. 38 39 Included/excluded studies tables, generated automatically from the study 40 information database, were used to summarise general information about 41 each study (see Appendix 15). Where meta-analysis was not appropriate 42 and/or possible, the reported results from each primary-level study were also 43 presented in the included studies table (and included, where appropriate, in a 44 narrative review).

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1 2 Consultation was used to overcome difficulties with coding. Data from 3 studies included in existing systematic reviews were extracted independently 4 by one reviewer and cross-checked with the existing data set. Where possible, 5 two independent reviewers extracted data from new studies. Where double 6 data extraction was not possible, data extracted by one reviewer was checked 7 by the second reviewer. Disagreements were resolved with discussion. Where 8 consensus could not be reached, a third reviewer resolved the disagreement. 9 Masked assessment (that is, blind to the journal from which the article comes, 10 the authors, the institution and the magnitude of the effect) was not used 11 since it is unclear that doing so reduces bias (Jadad et al., 1996; Berlin, 2001).

12 3.5.4 Presenting the data to the GDG 13 Summary characteristics tables and, where appropriate, forest plots generated 14 with Review Manager were presented to the GDG in order to prepare an 15 evidence profile for each review and to develop recommendations. 16 Evidence profile tables 17 An evidence profile table was used to summarise both the quality of the 18 evidence and the results of the evidence synthesis (see Table 1 for an example 19 of an evidence profile table). Each table included details about the quality 20 assessment of each outcome: number of studies, the study design, limitations 21 (based on the quality of individual studies; see Appendix 12 for the quality 22 checklists and Appendix 15 for details about each study), information about 23 the consistency of the evidence (see below for how consistency was 24 measured), directness of the evidence (that is, how closely the outcome 25 measures, interventions and participants match those of interest) and any 26 other considerations (for example, effect sizes with wide confidence intervals 27 (CIs) would be described as imprecise data). Each evidence profile also 28 included a summary of the findings: number of patients included in each 29 group, an estimate of the magnitude of the effect, and quality of the evidence. 30 The quality of the evidence was based on the quality assessment components 31 (study design, limitations to study quality, consistency, directness and any 32 other considerations) and graded using the following definitions: 33 • High = Further research is very unlikely to change our confidence 34 in the estimate of the effect

35 • Moderate = Further research is likely to have an important impact 36 on our confidence in the estimate of the effect and may change the 37 estimate

38 • Low = Further research is very likely to have an important impact 39 on our confidence in the estimate of the effect and is likely to 40 change the estimate

41 • Very low = Any estimate of effect is very uncertain.

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1 For further information about the process and the rationale of producing an 2 evidence profile table, see GRADE (2004).

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Table 1: Example of GRADE evidence profile for methadone maintenance treatment plus contingency management versus methadone maintenance treatment plus control (not all outcomes are shown) Summary of findings Quality assessment No of patients Effect Impor Other Relative Absolute Quality No of studies Design Limitations Consistency Directness MMT+ -tance considerations MMT+CM control (95% CI) (95% CI) Minimum 3-26 weeks’ abstinence (Chutuape, 2001; McClellan, 1993; Petry, 2002; Pierce, 2006; Rawson, 2002; Schottenfeld, 2005; Silverman, 1998; Silverman, 2004; Stitzer, 1992)

Some 130/403 34/404 RR 3.89 - ⊕⊕⊕⊕ No No important uncertainty Strong 9 RCT limitations inconsistency (-1)1 association (+1)2 (32.3%) (8.4%) (2.78 to 5.45) High 9 Minimum 3-6 weeks’ abstinence (Petry, 2002; Rawson, 2002; Silverman, 1998; Stitzer, 1992)

48/94 15/97 RR 3.28 - ⊕⊕⊕⊕ Some No No important uncertainty Strong 4 RCT limitations3 inconsistency (-1)1 association (+1)2 51.1% 15.5% (2.00 to 5.36) High 9 Minimum 8-12 weeks’ abstinence (Chutuape, 2001; McClellan, 1993; Pierce, 2006; Schottenfeld, 2005)

- ⊕⊕⊕⊕ Some 71/283 19/281 RR 3.87 No No important uncertainty Strong 4 RCT limitations inconsistency (-1)1 association (+1)2 25.1% 6.8% (2.43 to 6.16) High 9 Minimum of 26 weeks’ abstinence (Silverman, 2004)

Imprecise or 3 Important Some sparse data (-1) 11/26 0/26 RR 23.00 - ⊕⊕⊕⊕ No inconsistency uncertainty Very strong 1 RCT limitations3 (-1)2 (-1)1 association (+2)4 42.3% 0% (1.43 to 371.00) High 9 Abstinence (6-month follow-up) (Rawson; 2002; Petry, 2005c)

Some 28/70 15/67 RR 1.81 - ⊕⊕⊕ No No important uncertainty 2 RCT limitations inconsistency (-1)1 None 40% 22.4% (1.07 to 3.06) Moderate 9 Abstinence from cocaine (6-month follow-up) (Petry, 2002)

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Imprecise or 19/221 23/639 - SMD -1.43 ⊕⊕⊕ Some sparse data (-1)3 No No important uncertainty Strong 1 RCT limitations inconsistency (-1)1 association (+1)5 8.6% 3.6% (-2.12 to 0.75) Moderate 9 Abstinence (12-month follow-up) (Rawson, 2002)

Some 16/30 8/30 RR 2.00 ⊕⊕ No No important uncertainty Imprecise or - 1 RCT limitations inconsistency (-1)1 sparse data (-1)3 53.3% 26.7% (1.01 to 3.95) Low 9

Footnotes: 1. No UK studies 2. RR > 2 3. 1 small study 4. RR > 5 5. SMD > 100

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1 Forest plots 2 3 Forest plots were used to present the results of the meta-analyses to the GDG 4 (see Appendix 15). Each forest plot displayed the effect size and confidence 5 interval (CI) for each study, as well as the overall summary statistic. 6 7 For dichotomous data, the graphs were generally organised so that the 8 display of data in the area to the right of the ‛line of no effect’ indicated a 9 favourable outcome for the treatment in question. Dichotomous outcomes 10 were presented as relative risks (RR) with the associated 95% CI (for an 11 example, see Figure 1). A relative risk (or risk ratio) is the ratio of the 12 treatment event rate to the control event rate. An RR of 1 indicates no 13 difference between treatment and control. 14 15 The CI shows with 95% certainty the range within which the true treatment 16 effect should lie and can be used to determine statistical significance. If the CI 17 does not cross the ‘line of no effect’, the effect is statistically significant. 18 19 Figure 1. Example of a forest plot displaying dichotomous data 20 Review: DMP: Brief Interventions Comparison: 01 Brief intervention for people not in formal drug treatment vs Self-help/information booklet Outcome: 01 Abstinence from stimulants (6month follow up)

Study Brief intervention Control RR (fixed) RR (fixed) or sub-category n/N n/N 95% CI 95% CI

Baker 2005 25/74 13/74 1.92 [1.07, 3.46] Bernstein 2005 90/403 63/375 1.33 [1.00, 1.78] Marsden2006 86/166 78/176 1.17 [0.94, 1.46]

Total (95% CI) 643 625 1.30 [1.09, 1.55] Total events: 201 (Brief intervention), 154 (Control) Test for heterogeneity: Chi² = 2.62, df = 2 (P = 0.27), I² = 23.6% Test for overall effect: Z = 2.99 (P = 0.003)

0.1 0.2 0.5 1 2 5 10 21 Favours Control Favours Brief 22

23 For continuous data, the graphs were generally organised so that the 24 display of data in the area to the left of the ‛line of no effect’ indicated a 25 favourable outcome for the treatment in question. Continuous outcomes 26 were analysed as weighted mean differences (WMD), or as standardised 27 mean differences (SMD) when different measures were used in different 28 studies to estimate the same underlying effect (for an example, see 29 30 Figure 2). If provided, intention-to-treat data, using a method such as ‘last 31 observation carried forward’, were preferred over data from completers. 32 33 34

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1 Figure 2: Example of a forest plot displaying continuous data 2 Review: NCCMH clinical guideline review (Example) Comparison: 01 Intervention A compared to a control group Outcome: 03 Mean frequency (endpoint)

Study Intervention A Control SMD (fixed) Weight SMD (fixed) or sub-category N Mean (SD) N Mean (SD) 95% CI % 95% CI

01 Intervention A vs. control Freeman1988 32 1.30(3.40) 20 3.70(3.60) 25.91 -0.68 [-1.25, -0.10] Griffiths1994 20 1.25(1.45) 22 4.14(2.21) 17.83 -1.50 [-2.20, -0.81] Lee1986 14 3.70(4.00) 14 10.10(17.50) 15.08 -0.49 [-1.24, 0.26] Treasure1994 28 44.23(27.04) 24 61.40(24.97) 27.28 -0.65 [-1.21, -0.09] Wolf1992 15 5.30(5.10) 11 7.10(4.60) 13.90 -0.36 [-1.14, 0.43] Subtotal (95% CI) 109 91 100.00 -0.74 [-1.04, -0.45] Test for heterogeneity: Chi² = 6.13, df = 4 (P = 0.19), I² = 34.8% Test for overall effect: Z = 4.98 (P < 0.00001)

-4 -2 0 2 4 3 Favours intervention Favours control 4 5 To check for consistency between studies, both the I2 test of heterogeneity and 6 a visual inspection of the forest plots were used. The I2 statistic describes the 7 proportion of total variation in study estimates that is due to heterogeneity 8 (Higgins & Thompson, 2002). The I2 statistic was interpreted in the follow 9 way: 10 • > 50%: notable heterogeneity (an attempt was made to explain the 11 variation, for example outliers were removed from the analysis or 12 sub-analyses were conducted to examine the possibility of 13 moderators. If studies with heterogeneous results were found to be 14 comparable, a random-effects model was used to summarise the 15 results (DerSimonian & Laird, 1986). In the random-effects analysis, 16 heterogeneity is accounted for both in the width of CIs and in the 17 estimate of the treatment effect. With decreasing heterogeneity, the 18 random-effects approach moves asymptotically towards a fixed- 19 effects model)

20 • 30 to 50%: moderate heterogeneity (both the chi-squared test of 21 heterogeneity and a visual inspection of the forest plot were used to 22 decide between a fixed- and random-effects model)

23 • < 30%: mild heterogeneity (a fixed-effects model was used to 24 synthesise the results).

25 3.5.5 Forming the clinical summaries and recommendations 26 27 The included study tables, forest plots and evidence profiles formed the basis 28 for developing the evidence summaries and recommendations. 29 30 For intervention studies, quality assessment was conducted using SIGN 31 methodology (SIGN, 2002) and classified according to a hierarchy (see Text 32 Box 4). 33

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1 Once the evidence profile tables and evidence summaries were finalised and 2 agreed by the GDG, recommendations were developed, taking into account 3 factors from the evidence, including trade-offs between the benefits and risks 4 of treatment. Other important factors that were considered in developing 5 recommendations included economic considerations, values of the GDG and 6 society, and the group’s awareness of practical issues (Eccles et al., 1998). 7 8 Text Box 4: Levels of evidence for intervention studies

Level Type of evidence 1++ High-quality meta-analyses, systematic reviews of RCTs or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias 1¯ Meta-analyses, systematic reviews of RCTs or RCTs with a high risk of bias* 2++ High-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal 2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal 2¯ Case–control or cohort studies with a high risk of confounding bias or chance and a significant risk that the relationship is not causal* 3 Non-analytic studies (for example, case reports and case series)

4 Expert opinion, consensus methods

*Studies with a level of evidence ′–′ should not be used as a basis for making a recommendation

Reproduced with permission from the Scottish Intercollegiate Guidelines Network 9

10 3.5.6 Consensus method used to answer a key question in the 11 absence of appropriately designed, high-quality research 12 In the absence of level I evidence (or a level that is appropriate to the 13 question), or where the GDG were of the opinion (on the basis of previous 14 searches or their knowledge of the literature) that there was unlikely to be 15 such evidence, a consensus process was adopted. This process focused on 16 those questions that the GDG considered a priority. 17 18 The starting point for the process of consensus was that a member of the topic 19 group identified, with help from the systematic reviewer, a narrative review 20 that most directly addressed the key question. Where this was not possible, a 21 brief review of the recent literature was initiated. 22 23 This existing narrative review or new review was used as a basis for 24 beginning an iterative process to identify lower levels of evidence relevant to 25 the clinical question and to lead to written statements for the guideline. The 26 process involved a number of steps:

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1 2 1. A description of what is known about the issues concerning the clinical 3 question was written by one of the topic group members.

4 2. Evidence from the existing review or new review was then presented in 5 narrative form to the GDG and further comments were sought about the 6 evidence and its perceived relevance to the clinical question.

7 3. Based on the feedback from the GDG, additional information was sought 8 and added to the information collected. This may include studies that did 9 not directly address the clinical question but were thought to contain 10 relevant data.

11 4. If, during the course of preparing the report, a significant body of primary- 12 level studies (of appropriate design to answer the question) were 13 identified, a full systematic review was done.

14 5. At this time, subject possibly to further reviews of the evidence, a series of 15 statements that directly addressed the clinical question were developed.

16 6. Following this, on occasions and as deemed appropriate by the 17 development group, the report was then sent to appointed experts outside 18 of the GDG for peer review and comment. The information from this 19 process was then fed back to the GDG for further discussion of the 20 statements.

21 7. Recommendations were then developed and could also be sent for further 22 external peer review.

23 8. After this final stage of comment, the statements and recommendations 24 were again reviewed and agreed upon by the GDG.

25 3.6 Health economics review strategies 26 The aim of the health economics review was to contribute to the guideline’s 27 development by providing evidence on the economic burden of drug misuse 28 as well as on the relative cost effectiveness of different treatment options 29 covered in the guideline. Where available, relevant evidence was collected 30 and assessed in order to help the decision-making process. 31 32 This process was based on a preliminary analysis of the clinical evidence and 33 had two stages: 34 • identification of the areas with likely major cost impacts within the 35 scope of the guideline

36 • systematic review of existing data on the economic burden of drug 37 misuse and cost-effectiveness evidence of different psychosocial 38 treatment options for problem drug misuse.

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1 In addition, in areas with likely major resource implications where relevant 2 data did not already exist, a primary economic analysis based on available 3 effectiveness data was undertaken alongside the guideline development 4 process, in order to provide cost-effectiveness evidence and assist decision 5 making.

6 3.6.1 Key economic issues 7 The following economic issues relating to the epidemiology and the 8 management of drug misuse were identified by the GDG in collaboration 9 with the health economist as primary key issues that should be considered in 10 the guideline: 11 • the global economic burden of drug misuse with specific reference 12 to the UK

13 • comparative cost effectiveness between psychological and physical 14 interventions for the treatment of drug misuse

15 • comparative cost effectiveness between different types of service 16 provision appropriate for the management of drug misuse.

17 3.6.2 Systematic literature review 18 A systematic review of the health economics evidence was conducted. The 19 aim of the review was threefold: 20 • to identify publications providing information on the economic 21 burden of drug misuse relevant to the UK context

22 • to identify existing economic evaluations of pharmacological, 23 psychological and physical treatment interventions, as well as of 24 appropriate forms of service configuration, for the management of 25 problem drug users, that could be transferable to the UK patient 26 population and healthcare setting

27 • to identify studies reporting health-state utility data transferable to 28 the UK population to facilitate a possible cost–utility modelling 29 process.

30 Although no attempt was made to review systematically studies with only 31 resource use or cost data, relevant UK-based information was extracted for 32 future modelling exercises if it was considered appropriate.

33 3.6.3 Search strategy 34 For the systematic review of economic evidence on drug misuse and its 35 psychosocial interventions, the standard mental health related bibliographic 36 databases (EMBASE, MEDLINE, CINAHL, PsychINFO and HTA) were 37 searched. For these databases, a health economics search filter adapted from 38 the Centre for Reviews and Dissemination (CRD) at the University of York 39 was used in combination with a general filter for drug misuse. The subject

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1 filter employed a combination of free-text terms and medical subject 2 headings, with subject headings having been exploded. Additional searches 3 were performed in specific health economics databases (NHS EED, OHE 4 HEED). HTA and NHS EED databases were accessed via the Cochrane 5 Library, using the general filter for drug misuse. OHE HEED was searched 6 using a shorter, database-specific strategy. Initial searches were performed 7 between November 2005 and October 2006. The searches were updated 8 regularly, with the final search between 6 and 8 weeks before the first 9 consultation. 10 11 In order to identify economic evidence on different types of service 12 configurations appropriate for problem drug users, further searches were 13 undertaken using the same electronic databases. In this case a similar 14 methodology was applied, but a service configuration–focused filter was 15 used. 16 17 In parallel to searches of electronic databases, reference lists of eligible studies 18 and relevant reviews were searched by hand, and experts in the field of 19 psychosocial interventions for drug misuse and mental health economics 20 were contacted in order to identify additional relevant published and 21 unpublished studies. Studies included in the clinical evidence review were 22 also screened for economic evidence. 23 24 The database searches for general health economics evidence related to 25 psychosocial interventions for drug misuse resulted in over 14,342 references. 26 Of these, 758 were identified as being potentially relevant. Secondary searches 27 using ‘needle exchange’, ‘economic’, ‘cost’, ‘heroin’, ‘opiate’, ‘QALY’, 28 ‘substance abuse’, and ‘crime’ yielded 121 references. Additional searches for 29 relevant ‘contingency management’ and ‘pharmacoeconomic’ papers resulted 30 in a further 49 references, of which only six were considered acceptable in 31 terms of basic criteria for health economics appraisal (as reported in 32 Drummond, 1997). Further potentially eligible studies (including those where 33 relevance/eligibility was not clear from the abstract) were obtained, a total of 34 12 papers. At this stage, inclusion was not limited to papers only from the UK. 35 In total, 37 relevant effectiveness and health economics references were 36 determined to be pertinent to the health economics of drug misuse. 37 38 Full texts of all potentially eligible studies (including those for which 39 relevance/eligibility was not clear from the abstract) were obtained. These 40 publications were then assessed against a set of standard inclusion criteria by 41 the health economist, and papers eligible for inclusion as economic 42 evaluations were subsequently assessed for internal validity. The quality 43 assessment was based on the 35-point checklist used by the British Medical 44 Journal to assist referees in appraising full economic analyses (Drummond & 45 Jefferson, 1996) (Appendix 12).

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1 3.6.4 Selection criteria 2 The following inclusion criteria were applied to select studies identified by 3 the economic searches for further analysis: 4 • No restriction was placed on language or publication status of the 5 papers.

6 • Studies published between 1985 and 2006 were included. This date 7 restriction was imposed in order to obtain data relevant to current 8 healthcare settings and costs.

9 • Only studies from Organisation for Economic Co-operation and 10 Development (OECD) countries were included, as the aim of the 11 review was to identify economic information transferable to the UK 12 context. For the systematic review on the cost effectiveness of 13 different types of service configuration, only studies conducted in 14 the UK were considered, as it was believed that resource use 15 associated with various types of service provision was likely to 16 differ significantly between the UK and other OECD countries.

17 • Selection criteria based on types of clinical conditions and patients 18 were identical to the clinical literature review.

19 • Studies were included provided that sufficient details regarding 20 methods and results were available to enable the methodological 21 quality of the study to be assessed, and provided that the study’s 22 data and results were extractable.

23 Additional selection criteria were applied in the case of economic evaluations:

24 • Only full economic evaluations that compared two or more options 25 and considered both costs and consequences (that is, cost- 26 minimisation analysis, cost–consequences analysis, cost- 27 effectiveness analysis, cost–utility analysis or cost–benefit analysis) 28 were included in the review.

29 • Economic studies were considered only if they utilised clinical 30 evidence derived from a meta-analysis, a well-conducted literature 31 review, a randomised controlled trial, a quasi-experimental trial or 32 a cohort study.

33 3.6.5 Data extraction 34 Data were extracted by the health economist using an economic data 35 extraction form (Appendix 13). Masked assessment, whereby data extractors 36 are blind to the details of journal, authors, and so on, was not undertaken.

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1 3.6.6 Presentation of the results 2 The economic evidence identified by the health economics systematic review 3 is summarised in the respective chapters of the guideline, following 4 presentation of the clinical evidence. The characteristics and results of all 5 economic studies included in the review are provided in the form of evidence 6 tables in Appendix 14. Results of additional economic modelling undertaken 7 alongside the guideline development process are also presented in the 8 relevant chapters.

9 3.7 Stakeholder contributions 10 Professionals, service users and companies have contributed to and 11 commented on the guideline at key stages in its development. Stakeholders 12 for this guideline include: 13 • service user/carer stakeholders: the national service user and carer 14 organisations that represent people whose care is described in this 15 guideline

16 • professional stakeholders: the national organisations that represent 17 healthcare professionals who are providing services to service users

18 • commercial stakeholders: the companies that manufacture 19 medicines used in the treatment of drug misuse

20 • Primary Care Trusts

21 • Department of Health and Welsh Assembly Government.

22 Stakeholders have been involved in the guideline’s development at the 23 following points: 24 • commenting on the initial scope of the guideline and attending a 25 briefing meeting held by NICE

26 • contributing possible clinical questions and lists of evidence to the 27 GDG

28 • commenting on the first and second drafts of the guideline.

29 3.8 Validation of this guideline 30 Registered stakeholders had two opportunities to comment on the draft 31 guideline, which was posted on the NICE website during the consultation 32 periods. The GRP also reviewed the guideline and checked that stakeholders’ 33 comments had been addressed. 34 35 Following the final consultation period, the GDG finalised the 36 recommendations and the NCCMH produced the final documents. These 37 were then submitted to NICE. NICE then formally approved the guideline 38 and issued its guidance to the NHS in England and Wales.

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1 4 Introduction to drug misuse

2 4.1 Drug misuse 3 This guideline is concerned with psychosocial treatment of the misuse of 4 opiates, stimulants and cannabis. In the UK, it has been estimated that around 5 4 million people use illicit drugs each year, with cannabis by far the most 6 commonly used, followed by cocaine and ecstasy (Roe & Man, 2006). Opiate 7 misuse occurs on a smaller scale but is associated with much greater rates of 8 harm than either cocaine or cannabis. 9 10 Opiates refer to a class of psychoactive substances derived from the poppy 11 plant, including opium, morphine and codeine, as well as semi-synthetic 12 forms including heroin (WHO, 2004). In this guideline, the term ‘opiate’ is 13 used more broadly to incorporate synthetic compounds (including 14 methadone and buprenorphine) with similar properties, also commonly 15 known as opioids (WHO, 2004). Illicit use of opiates generally involves 16 injection, or inhalation of the fumes produced by heating the drug. 17 Stimulants refer broadly to any substance that activates, enhances or increases 18 neural activity (WHO, 2006). 19 20 Illicit stimulants include cocaine, crack cocaine and amphetamines. Cocaine is 21 one of the most commonly misused illicit stimulants in the UK (Roe & Man, 22 2006). Cocaine is extracted from the leaf of the coca plant and generally 23 sniffed in powder form. Crack cocaine is usually smoked but sometimes 24 injected. Amphetamines are a group of synthetic substances with different 25 chemical structures but broadly similar stimulant properties to cocaine, and 26 include dexamfetamine sulphate (a prescription drug licensed for the 27 treatment of narcolepsy and attention-deficit hyperactivity disorder [ADHD]) 28 but which has misuse potential) and methamphetamine. 29 30 Cannabis is a generic term denoting the various preparations of the cannabis 31 sativa plant, including cannabis leaves (the most common form, which is 32 smoked), hashish resin and the rarely used cannabis oil. 33 Tetrahydrocannabinol (THC) is the key constituent of cannabis that produces 34 the psychoactive effect sought by most users, and the different forms of 35 cannabis vary in their THC content. (WHO, 2006). Cannabis is the most 36 commonly used illicit drug in the UK (Roe & Man, 2006). 37 38 Definitions 39 Drug misuse is defined as the use of a substance for a purpose not consistent 40 with legal or medical guidelines (WHO, 2006). It has negative impacts on 41 health or functioning and may take the form of drug dependence, or be part 42 of a wider spectrum of problematic or harmful behaviour (Department of 43 Health, 2006). In the UK, the Advisory Council on the Misuse of Drugs

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1 (ACMD) characterises problem drug use as a condition that may cause an 2 individual to experience social, psychological, physical or legal problems 3 related to intoxication and/or regular excessive consumption, and/or 4 dependence, as a consequence of his or her use of drugs or other chemical 5 substances (ACMD, 1998). 6 7 In this guideline, dependence is defined as a strong desire or sense of 8 compulsion to take a substance, a difficulty in controlling its use, the presence 9 of a physiological withdrawal state, tolerance of the use of the drug, neglect of 10 alternative pleasures and interests and persistent use of the drug, despite 11 harm to oneself and others (WHO, 2006). Dependence is diagnosed according 12 to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) when 13 three or more of the following criteria are present in a 12-month period: 14 tolerance; withdrawal; increasing use over time; persistent or unsuccessful 15 attempts to reduce use; preoccupation or excessive time spent on use or 16 recovery from use; negative impact on social, occupational or recreational 17 activity; and continued use despite evidence of its causing psychological or 18 physical problems (APA, 1994). 19 20 The diagnosis of dependence is clearest with opiates. The WHO states that 21 'opioid dependence develops after a period of regular use of opioids, with the 22 time required varying according to the quantity, frequency and route of 23 administration, as well as factors of individual vulnerability and the context 24 in which drug use occurs. Opioid dependence is not just a heavy use of the 25 drug but a complex health connotation that has social, psychological and 26 biological determinants and consequences, including changes in the brain. It 27 is not a weakness of character or will.' (WHO, 2006) However, under the 28 above definition, dependence can also occur with stimulants and cannabis. 29 30 Repeated use of a drug can lead to the development of tolerance in which 31 increased doses of the drug are required to produce the same effect. Tolerance 32 develops to opiate, stimulants and cannabis. Cessation of use leads to reduced 33 tolerance and this may present significant risks for people who misuse drugs 34 who return to drug doses at a level to which they had previously developed 35 tolerance. This can lead to accidental overdoses and, in the case of opiate 36 misuse, could lead to respiratory depression and death. 37 38 Withdrawal syndromes have clearly been identified after cessation or 39 reduction of opiate and stimulant use. DSM-IV criteria for a withdrawal 40 disorder include the development of a substance-specific syndrome due to 41 cessation or reduction in use; the syndrome causing clinically significant 42 distress; and symptoms not due to a general medical condition or better 43 explained by another mental disorder (American Psychiatric Association, 44 1994). Whilst withdrawal effects have been associated with cessation of heavy 45 cannabis use, their clinical significance is presently uncertain (Budney et al., 46 2004).

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1 2 Opiates, stimulants and cannabis also produce intoxication, that is, 3 disturbances in psychophysiological functions and responses, including 4 consciousness, cognition and behaviour, following administration of a 5 psychoactive substance (WHO, 2006). These are described in greater detail in 6 section 4.5. 7 8 People who misuse drugs may present with a range of health and social 9 problems other than dependence, which may include (particularly with opiate 10 users): 11 12 • physical health problems (for example, thrombosis, abscesses, overdose, 13 hepatitis B and C, HIV, and respiratory and cardiac problems)

14 • mental health problems (for example, depression, anxiety, paranoia, and 15 suicidal thoughts)

16 • social difficulties (for example, relationship problems, financial 17 difficulties, unemployment and homelessness)

18 • criminal justice problems.

19 Many people who misuse drugs use a range of substances concurrently and 20 regularly (known as poly-drug misuse). The use of opiates alongside cocaine 21 or crack cocaine is common, with the National Drug Treatment Monitoring 22 System (NDTMS), which collects, collates and analyses information from 23 those involved in the drug treatment system, reporting an increase in the use 24 of both drugs, from 18% of those presenting for drug treatment in 1998 to 24% 25 in 2001 (NTA, 2005). Alcohol misuse is also common in all types of people 26 who misuse drugs; data from the National Treatment Outcomes Research 27 Study (NTORS) suggested that 22% of participants drank alcohol frequently, 28 17% drank extremely heavily and 8% drank an excessive amount on a daily 29 basis (Gossop et al., 2000a). People who misuse opiates in particular may often 30 take a cocktail of substances, including alcohol, cannabis and prescribed 31 drugs such as benzodiazepines, which can have particularly dangerous effects 32 in comparison to those of each drug taken by itself. 33 34 Drug dependence is associated with a high incidence of criminal activity with 35 associated costs to the criminal justice system in the UK estimated as reaching 36 £1 billion per annum in 1996 (United Kingdom Anti-Drugs Coordinating 37 Unit, 1998). For example, more than 17,000 offences were reported by an 38 NTORS cohort of 753 participants in a 90-day period before entering 39 treatment (Gossop et al., 2000b). Notably, most of the offences were 40 committed by a small proportion of the cohort (10% of participants accounted 41 for 76% of the crimes). Illicit drug use is also much more common amongst 42 known offenders in the UK than amongst comparable age cohorts drawn 43 from the general population. In a sample of 1,435 arrestees drug-tested and

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1 interviewed by Bennett and colleagues (2001), 24% tested positive for opiates. 2 The average weekly expenditure on drugs (heroin and crack/cocaine) was 3 £290, and the main sources of illegal income were theft, burglary, robbery, 4 handling stolen goods and fraud. The NTORS also found 61% of a drug 5 misuse treatment sample reported committing crimes other than drug 6 possession in the 3 months prior to starting treatment, with the most 7 commonly reported offence shoplifting.) In addition, there is a high 8 prevalence of drug misuse among the incarcerated population: between 41 9 and 54% of remand and sentenced prisoners were reported to be opiate, 10 stimulant and/or cannabis dependent in the year prior to incarceration 11 (Singleton et al., 1999). Drug treatment can lead to significant reductions in 12 offending levels (Gossop et al., 2003) and, as a consequence, the prison and the 13 broader criminal justice system is an increasingly significant referral source 14 and venue for the provision of drug treatment.

15 4.2 Epidemiology 16 According to the national British Crime Survey (Roe & Man, 2006), 34.9% of 17 16–59 year olds have used one or more illicit drugs in their lifetime, 10.5% in 18 the last year and 6.3% in the last month. These figures are much lower for 19 opiate use, with 0.1% of the population having used opiates (including heroin 20 and methadone) in the last year. However, estimates based on data that also 21 take into account other indicators such as current service usage provide an 22 illicit drug use figure of 9.35 per thousand of the population aged 15–64 years 23 (360,811), of whom 3.2 per thousand (123,498) are injecting dug users (Chivite- 24 Matthews et al., 2005). Analysis of the 2004/5 data from the NDTMS suggests 25 that there were an estimated 160,450 people in contact with treatment services 26 in England during that period, the majority for primary opiate misuse 27 (National Treatment Agency, 2005b). Males comprise over 70% of new 28 presentations to treatment, and the majority of those requiring treatment are 29 opiate dependent (typically using illicit heroin). Similar figures have emerged 30 from Frischer and colleagues (2001), who estimated that 0.5% of the 31 population of Britain (that is, 226,000 people) to be problem drug users. More 32 recent estimates indicate that there are around 327,000 problem (opiate 33 and/or crack cocaine use) drug users in the UK, with 280,000 of these opiate 34 users (Hay et al., 2006). 35 36 Drug misuse is commoner in certain vulnerable groups. For example, Ward 37 and colleagues (2003) found that amongst care leavers aged between 14 and 38 24 years, drug misuse is much higher than in the general population, with 39 three quarters of the sample having at some time misused a drug and over 40 half having misused a drug in the previous month. Levels in the young 41 homeless population are also much higher than the general population, with 42 one survey finding that almost all (95%) of the sample had at some time 43 misused drugs, many (76%) having used cocaine, heroin, and/or 44 amphetamine in the past month. 45

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1 4.3 Aetiology and maintenance of drug misuse 2 3 Drug misuse is increasingly portrayed in the field as a medical disorder 4 (known as the ‘disease model’ of drug misuse), in part due to advances in our 5 understanding of the neurobiology underlying dependence (Volkow & Li, 6 2005). There is also no question that numerous socioeconomic and 7 psychological factors all play an important part in the aetiology of drug 8 misuse. These conceptualisations are not mutually exclusive, rather they are 9 facets of the multifactorial aetiology of drug misuse. 10 11 A defining characteristic of drug dependence is that drug use initiates as a 12 voluntary action to seek a rewarding stimulus, but continued use results in 13 loss of control over the use, despite its negative consequences (Dackis & 14 O’Brien, 2005). The effects of many illicit drugs are mediated via various brain 15 circuits, in particular the mesolimbic systems, which have evolved to respond 16 to basic rewards (such as food and sex) to ensure survival. A diverse range of 17 substances, including opiates, stimulants and cannabis, as well as alcohol and 18 nicotine, all appear to produce euphoric effects via increasing levels of 19 dopamine (a neurotransmitter) in the nucleus accumbens (Dackis & O’Brien, 20 2005). This has been well demonstrated in human brain-imaging studies 21 (Volkow et al., 1999). Euphoria resulting from use then potentiates further use, 22 particularly for those with a genetic vulnerability (see below). Chronic drug 23 use may produce long-lasting changes in the reward circuits, including 24 reductions in dopamine receptor levels (Volkow et al., 1999), and again these 25 contribute to the clinical course of drug dependence, including craving, 26 tolerance and withdrawal (Lingford-Hughes & Nutt, 2003). In addition, other 27 types of neurotransmitter systems (for example, opiates, glutamates and 28 cannabinoids) are implicated in the misuse of specific drugs. 29 30 Studies of twins, families, and people who have been adopted show that 31 vulnerability to drug misuse may have a genetic component (Prescott et al., 32 2006), but it is not clear whether for a given individual repeated use is 33 primarily determined by genetic predisposition or whether socioeconomic 34 and psychological factors lead an individual to try and then later to use 35 opiates compulsively. Family relationships play a part and experiences such 36 as childhood neglect, homelessness or abuse increase the likelihood that the 37 individual will develop problems with drugs later on in life (Kumpfer & 38 Bluth, 2004). Risk factors for heavy, dependent drug use are much more 39 significant when they occur together rather than individually. 40 41 Initiation into drug use does not lead inevitably to regular and problematic 42 use for many people. Vulnerability to use is highest among young people, 43 with most problem heroin users initiating before the age of 20. Individuals 44 dependent on drugs often become so in their early twenties and may remain 45 intermittently dependent for many years. However, it is clear that when use 46 begins, it often escalates to misuse and then to dependence (tolerance,

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1 withdrawal symptoms and compulsive drug-taking). Once dependence is 2 established, particularly with opiates, there may be repeated cycles of 3 cessation and relapse extending over decades (National Consensus 4 Development Panel on Effective Medical Treatment of Opiate Addiction, 5 1998). 6 7 Drug users exhibit different patterns of use, which includes intermittent 8 ’recreational’ use to dependent heroin injecting. Recreational use is more 9 common with cannabis and cocaine and it is likely that there are different 10 patterns of use, with cocaine use dividing between those who take the drug 11 on an episodic basis and those who take it on a daily basis; cannabis use in 12 contrast usually moves in only a small number of cases to repeated (daily) 13 increasingly heavy use, with many using intermittently. These differences 14 may relate to the different intensities of action different drugs produce within 15 the neural reward sites (Stimmel & Kreek, 2000). 16 17 The neurobiological account of fundamental reward systems implicated in 18 drug misuse may parallel the sociocultural–behavioural–cognitive model 19 presented by Orford (2001). He conceptualised drug misuse as an ‘excessive 20 appetite’, belonging to the same class of disorders as gambling, eating 21 disorders and sex addiction. All involve activities that form strong 22 attachment, and were once rewarding, but with excessive consumption result 23 in compulsion and negative consequences. Orford argues that the emotional 24 regulation of such appetitive behaviours in their respective social contexts (for 25 example, the excitement associated with gambling or the anticipation of the 26 next ‘fix’ of heroin), well characterised within the principles of operant 27 conditioning, is a primary factor driving excessive use. Secondary factors such 28 as internal conflict (knowing that the behaviour is harmful yet being unable to 29 disengage from it) potentiate these emotions and thus excessive use, but an 30 alternative result is that the individual alters behaviour in order to resolve 31 such conflict. This crucially suggests that recovery is not impossible, but also 32 that successful treatment attempts are likely to operate against a background 33 of powerful natural processes (Orford, 2001). 34

35 4.4 The course of drug misuse 36 Drug misuse is a relapsing and remitting condition often involving numerous 37 treatment episodes over several years (Marsden et al., 2004). Of those 38 attending for treatment (predominantly opiate users), most individuals 39 develop dependence in their late teens or early twenties, several years after 40 their first use of heroin, and continue use over the next 10–20 years. In a long- 41 term outcome study (up to 24 years ) of 581 male opiate users in the US, 29% 42 were abstinent, 23% had positive urine tests for opiates, 18% were in prison 43 and 28% were dead (Hser et al., 1993). Longitudinal data from the US also 44 showed that the average time from first to last opiate use was 9.9 years, with 45 40% addicted for over 12 years (Joe et al., 1990). Although it is the case that

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1 problem drug users can cease drug use without any formal treatment 2 (Biernacki, 1986), for many it is treatment that alters the course of opiate 3 dependence. 4 5 Although drug misuse can affect all socioeconomic groups, deprivation and 6 social exclusion are likely to make a significant contribution to the 7 maintenance of drug misuse (ACMD, 1998). 8 9 Factors that influence the cessation of drug use in adulthood are similar to 10 those associated with lack of drug use in adolescence. For example, 11 conventionality in a social role (such as a job, mortgage or marriage), a social 12 context not favourable to using drugs (for example, employment), and good 13 health are not associated with long-term use. Peer influences are a major 14 influence on experimental use and are also likely to influence the move 15 towards regular use. The level of drug use is also a predictor of continued use; 16 the more used, the more likelihood there is of continued problematic use. 17 Once an individual is dependent, drug use is generally a chronic condition, 18 interspersed with periods of relapse and remission. Repeated interaction with 19 the criminal justice system, long-term unemployment and increasing social 20 isolation serve to further entrench drug use. 21

22 4.5 The pharmacological effects of drug misuse 23 Opiates 24 Opiate drugs have many effects on the brain, mediated through specific 25 receptors (mu, kappa or delta) in particular areas of the brain. The key opiate 26 receptor subtype is mu, which mediates ‘liking’ as well as respiratory 27 depression and is the main target for opiates (Lingford-Hughes & Nutt, 2003). 28 The kappa receptor is involved in mood regulation. Drugs such as heroin and 29 methadone are agonists, which stimulate the receptor. Buprenorphine is a 30 partial agonist; that is, it occupies the receptors in the same way but only 31 partially activates it. In addition, it is an antagonist at the kappa receptor and 32 therefore is less likely to lower mood compared to agonists. 33 34 Soon after injection (or inhalation), heroin metabolises into morphine and 35 binds to opiate receptors. This is subjectively experienced as a euphoric rush, 36 normally accompanied by warm flush, dry mouth, and sometimes nausea, 37 vomiting and severe itching. As the rush wears off, drowsiness, slowing of 38 cardiac function and breathing (sometimes to the point of death in an 39 overdose) persist for several hours (NIDA, 2005a). The effects of methadone 40 are similar but more drawn out and therefore less intense (lasting up to 24 41 hours when taken orally as prescribed); however, this may be circumvented 42 by illicit users who inject the drug. 43 44 The most obvious consequence of long-term opiate use is the development of 45 opiate dependence itself, and the associated harms. Repeated injection will

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1 also have medical consequences such as scarring, infection of blood vessels, 2 abscesses, and compromised functioning of the kidney, liver and lungs (with 3 increased vulnerability to infections). 4 5 Stimulants 6 As central nervous system stimulants, cocaine and amphetamine affect a 7 number of neurotransmitter systems in the brain but exert their effects 8 primarily via dopamine, which mediates reward. Cocaine blocks the 9 presynaptic reuptake of dopamine, such that it is not removed from the 10 intracellular space and leads to extended firing of post-synaptic neurons, 11 resulting in physiological arousal. Amphetamines also increase the 12 availability of dopamine but are thought to do so by triggering a presynaptic 13 leakage. 14 15 The acute subjective effects of cocaine are euphoria, increased energy, 16 heightened alertness, sexual arousal, increased sociability and talkativeness. 17 Physiologically there can be acute adverse effects on the breathing, 18 cardiovascular and central nervous systems: increased heart rate, blood 19 pressure and body temperature, and pupil dilation. All these effects have 20 near-immediate onset but also diminish quickly (roughly 15–30 minutes if the 21 drug is snorted and 5–10 minutes if smoked), as cocaine is metabolised 22 rapidly by the body (NIDA, 2005b). As acute effects wear off, users experience 23 a rebound period (’crash’) which may include restlessness, anxiety, agitation 24 and insomnia. This can lead to the user bingeing on cocaine in an attempt to 25 displace these negative effects. Chronic misuse of cocaine may lead to 26 increased paranoia, inability to concentrate, sexual dysfunction and cognitive 27 deficits. 28 29 For amphetamines, the acute effects are broadly similar except that they are 30 long lasting (normally 4–8 hours), due to slower metabolism. Overdoses may 31 lead to dangerously elevated body temperature, convulsions or even death. 32 Chronic misuse may cause long-term damages to the brain’s ability to 33 manufacture dopamine, possibly resulting in amphetamine psychosis. 34 35 Cannabis 36 Cannabis affects almost every body system, via cannabinoid receptors in the 37 brain, which regulate a range of cognitive and motor functions (Ashton, 2001; 38 NIDA, 2005c). Within minutes of smoking cannabis, the heart rate increases 39 and the bronchial passages relax. Often the individual experiences 40 intoxication, mild euphoria and increased sociability. However, anxiety or 41 paranoia may sometimes occur, particularly among first-time or 42 psychologically vulnerable users (Johns, 2001). Distorted perceptions are 43 common, for example colours may appear more intense and time may seem to 44 slow down. The euphoria reaches a plateau lasting 2 hours or more,

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1 depending on the dose, after which the individual may feel sleepy or 2 depressed. 3 4 Cannabis use also impairs memory, attention and motor co-ordination, with 5 especially dangerous consequences on driving performance. Such effects may 6 last for many hours after administration of the drug; the numerous 7 metabolites of a single moderate dose of cannabis may require up to 4 weeks 8 to be completely eliminated from the body (Maykut, 1985). The smoke from 9 cannabis contains the same constituents as tobacco smoke; hence chronic 10 cannabis smoking is associated with a range of respiratory tract disorders, 11 including bronchitis, emphysema and cancers (Hashibe et al, 2005; Tashkin, 12 1990). 13

14 4.6 The public health impact of drug misuse 15 The harms associated with illicit heroin use include increased mortality from 16 overdose and from other directly or indirectly associated harms such as 17 increased risk of infection with blood-borne viruses (HIV, hepatitis C and 18 hepatitis B); high levels of depression and anxiety disorders; social problems 19 such as disrupted parenting, employment and accommodation; and increased 20 participation in income-generating crime. 21 22 Mortality, particularly in heroin-dependent users, is high, with estimates of 23 between 12 times (Oppenheimer et al., 1994) and 22 times (Frischer et al., 1997) 24 that of the general population. In England and Wales, there were between 25 1,382 drug-related deaths in 2005 (National Programme on Substance Abuse 26 Deaths, 2005). The majority (59%) were cases of accidental poisoning, 27 although a sizeable proportion (16%) were of intentional self-poisoning. 28 Opiates (alone or in combination with other drugs) accounted for some 70% 29 of the deaths, and cocaine 13%. Many of the deaths appear to be due to 30 multiple drug toxicity, especially the presence of central nervous system 31 depressants (for example, alcohol and benzodiazepines), rather than simply 32 an ‘overdose’ of an opiate. This is supported by research that shows those 33 whose deaths were attributed to overdose have opiate levels no higher than 34 those who survive, or than heroin users who die from other causes (Darke & 35 Zador, 1996). Recent cohort studies have shown that mortality rates from 36 methadone-related death are decreasing (Brugal et al., 2005). 37 38 HIV infection is a major problem for injecting drug users, with the number of 39 new diagnoses of HIV in the UK holding at around a hundred for the last few 40 years, with 5.6% of all UK diagnoses attributed to injecting drug use by the 41 end of 2005 (Health Protection Agency, 2006). There are differences in 42 geographical distribution of HIV in the UK, with rates higher in some centres 43 such as London. Approximately 50% of injecting drug users have been 44 infected with hepatitis C, but this rate, like the HIV prevalence rate, is lower 45 than in many other countries (Health Protection Agency, 2006). Transmission 46 of both hepatitis A and B continues even though there are effective vaccines.

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1 Needle and syringe sharing increased in the late 1990s, and since then has 2 been stable with around one in three injecting drug users reporting this 3 activity in the last month (Health Protection Agency, 2005). 4 5 Psychiatric comorbidity is common in drug misuse populations, with anxiety 6 and depression generally common, as are antisocial and other personality 7 disorders in opioid-using populations (Regier et al., 1990, 1998).The national 8 US Epidemiological Catchment Area study of the prevalence of mental health 9 disorders reported a 47% lifetime prevalence rate of substance misuse (drugs 10 and alcohol) among patients with schizophrenia compared to 16% in the 11 general population, and that more than 60% of people with a diagnosis of 12 bipolar I disorder had a lifetime diagnosis of substance misuse disorder. 13 Around one in five of the patients in the NTORS sample had previously 14 received treatment for a psychiatric health problem other than substance 15 misuse (Marsden et al., 2000). Drug misuse disorders complicated by other 16 comorbid mental disorders have been recognised as having a poorer 17 prognosis and being more difficult to treat than those without comorbid 18 disorders; comorbid disorders are more likely to be chronic and disabling, 19 and result in greater service utilisation. 20 21 Lost productivity and unemployment increase with the severity and duration 22 of drug misuse, and personal relationships are placed under considerable 23 strain by dependent drug use. Problems with accommodation are also 24 common in such groups. For example, prior to intake in the NTORS, 7% of the 25 study group were homeless and living on the street, 5% were living in squats 26 and 8% were living in temporary hostel accommodation (Gossop et al., 1998). 27 Drug misuse may also have a negative impact on children and families. In the 28 UK it is estimated that 2–3% of all children under the age of 16 years have 29 parents with drug problems (ACMD, 2003). While use of opiates does not 30 necessarily impact on parenting capacity, registration on UK child protection 31 registers for neglect has been correlated strongly with parental heroin use, 32 and parental problem drug use has been shown to be one of the commonest 33 reasons for children being received into the care system (Barnard & 34 McKeganey, 2004).

35 4.7 Identification and assessment of drug misuse 36 37 Many drug users do not present to specific drug treatment services, but they 38 may present to other medical services, the criminal justice system and social 39 care agencies. Many will not be seeking help for their drug problems and a 40 significant proportion, for example some of those primarily misusing cocaine 41 or cannabis, may not be aware of the potentially harmful effects of their drug 42 use. 43 44 Routine screening for drug misuse is largely restricted in the UK to criminal 45 justice settings, including police custody and prisons (Matrix Research and

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1 Consultancy & NACRO, 2004); it is sparsely applied in health and social care 2 settings. For example, a recent study of psychiatric inpatients in London 3 found that only 1 in 50 patients admitted to hospital had undergone screening 4 for drug misuse (Barnaby et al., 2003). The updated National Treatment 5 Agency’s Models of Care service framework emphasises the importance of 6 non-specialist (Tier 1) services in the identification of drug misuse as a 7 precursor to referral for treatment (NTA, 2006). Opportunistic methods for the 8 effective identification of drug misuse should therefore be considered in a 9 variety of healthcare settings. These are described in Chapter 6. 10 11 For those identified and considering treatment, a good assessment is essential 12 to continuing care. Assessment skills are important across all of those health 13 and social care professionals who may come into contact with substance 14 misuse. Assessment includes information about past and current drug use 15 (amount, type, duration, periods of abstinence and effect of abstinence), 16 history of injecting, risk of HIV and other blood-borne viruses, medical 17 history, forensics and previous contact with treatment services. The 18 assessment of a patient is a continuous process carried out at every contact 19 with the individual and their healthcare professional/counsellor/social 20 worker and can be carried out over many years. Urine testing for the absence 21 or presence of drugs is an important part of assessment and monitoring. 22 Formal rating scales may be helpful in assessing outcomes and in certain 23 areas of monitoring, for example the monitoring of withdrawal symptoms.

24 4.8 The aims of the treatment and management of drug misuse 25 The clinical management of drug misuse may be categorised into three broad 26 approaches: harm reduction, maintenance oriented and abstinence oriented. 27 All treatments aim to prevent or reduce the harms resulting from use of 28 drugs. 29 30 Harm reduction aims to prevent or reduce negative health or other 31 consequences associated with drug misuse, whether to the drug-using 32 individual or to the wider society. With such approaches, it is not essential for 33 there to be a reduction in the drug use itself (although, of course, this may be 34 one of the methods of reducing harm). For instance, needle and syringe 35 exchange services aim to reduce transmission of blood-borne viruses through 36 the promotion of safer drug injecting behaviour. 37 38 Maintenance-oriented treatments in the UK context primarily refer to the 39 pharmacological maintenance of people who are opiate dependent, through 40 the prescription of opiate substitutes (methadone or buprenorphine). This 41 therapy aims to reduce or end their illicit drug use and the consequential 42 harms of such. 43 44 Abstinence-oriented treatments aim to reduce an individual’s level of drug 45 use, with the ultimate goal of abstinence. Although initially attractive, these

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1 may be associated with subsequent increased risk of overdose death in the 2 event of relapse after a period of abstinence during which drug tolerance is 3 lost (Verger, 2003). Consequently, it is particularly important for abstinence- 4 oriented treatment to include education on post-detoxification vulnerability to 5 relapse (Gossop et al., 1989) and to overdose, and for wider psychosocial 6 rehabilitation support to be provided. However, the NTORS found that 7 approximately one third of those entering treatment services were abstinent 5 8 years later (Gossop et al., 2003). 9 10 When developing any treatment or management plan, a number of factors 11 should influence the content of such a plan and include: 12 13 • type and pattern of use

14 • level of dependence

15 • comorbid mental and physical health problems

16 • location (for example, prison or community)

17 • age and gender

18 • patient aspirations and expectations.

19 The general principles of treatment include: no single treatment is appropriate 20 for all individuals; treatments should be readily available, and begin when the 21 service user presents; and the capacity to address multiple needs. It is also 22 accepted that treatments will change over time and that treatment does not 23 need to be voluntary to be successful. For most people in long-term treatment, 24 that is those with opiate dependence, substitute medications, such as 25 methadone and buprenorphine, are important elements of care. However, 26 services also need to address coexisting problems, such as mental health and 27 physical health problems, alongside the drug misuse. 28 29 Keyworking forms the core part of treatment for most service users with long- 30 term drug misuse problems (NTA, 2005). Typically, this involves the 31 following: 32 33 • conducting an assessment of need (and risk assessment) 34 • establishing and sustaining a therapeutic relationship 35 • clarification of the service user’s goals in relation to his/her drug use 36 • discussion, implementation, evaluation and revision of a treatment 37 plan to address the client’s goals and needs 38 • liaison and collaboration with other care providers 39 • integration of a range of interventions based on a biopsychosocial 40 model of drug use (for example, prescribing, addressing needs such as 41 housing and improving personal relationships)

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1 • use of one or more techniques derived from one or more therapeutic 2 models to engage and retain the client in treatment and to support the 3 treatment plan (for example, use of drug diaries and motivational 4 skills) in the absence of delivering a complete episode of formal 5 psychological therapy.

6 4.9 Current care and treatment in the NHS 7 The British response to drug problems dates back to the report of the 8 Rolleston Committee of 1926. The Committee accepted dependence as a 9 disease and established a medical approach to drug problems in Britain rather 10 than the predominantly punitive one pursued in other countries such as the 11 USA. Rolleston gave doctors a large degree of clinical freedom in their 12 response to patients who were addicted, including the use of maintenance 13 treatment. To this day, maintenance is considered an essential aspect of drug 14 treatment. 15 16 A large increase in the number of people with heroin dependence in Britain in 17 the mid-1960s prompted the establishment of a network of drug dependence 18 clinics set in psychiatric hospitals and run directly by the NHS. The second 19 British epidemic of heroin use in the early 1980s led to a further reshaping of 20 the British treatment response. A multidisciplinary approach was encouraged 21 through the establishment of community drug teams and attempts to increase 22 GP involvement in drug treatment, with the first in a series of clinical 23 guidelines setting out the responsibilities of the prescribing doctor (DH, 1999). 24 The guidelines also sought to encourage shared care of the person who 25 misuses drugs by different professional groups. While the drug dependence 26 clinics remained the cornerstone of this reshaped approach, the vast majority 27 of treatment prescriptions, namely oral methadone, were now dispensed by 28 community pharmacists and consumed at home. 29 30 The emergence of HIV/AIDS in the 1980s led to the introduction of needle 31 and syringe exchange schemes as an addition to the treatment services 32 available. These schemes provided needles and syringes to the dependent and 33 non-dependent injector. Harm reduction also became an important aspect of 34 treatment responses to drug misuse. Another refocusing of drug treatment 35 came in the 1990s, with increased concern over the link between criminal 36 activity and drug misuse. Criminal justice settings were seen as an important 37 conduit for getting people who misuse drugs into treatment and a number of 38 interventions such as Drug Treatment and Testing Orders (DTTOs) were 39 established. In 2003, the Home Office, with the Department of Health and the 40 National Treatment Agency as its key partners, introduced the Drug 41 Interventions Programme, which seeks to bring treatment and criminal justice 42 services together in responding to drug misuse (Witton et al., 2004). 43 44 Current practice

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1 Much of the current treatment of drug misuse in the NHS services (those 2 directly provided or purchased by the NHS) focuses on the treatment of 3 opiate misuse. In large part, this is reactive to the drug problems that service 4 users present, which may themselves be informed by awareness of relevant 5 treatments as well as their own perceptions of whether their drug use is 6 problematic. Few services are focused solely on the treatment of cocaine and 7 cannabis misuse; often these problems are only addressed when the primary 8 presenting problem is opiate misuse. In particular, the provision of treatment 9 is almost non-existent for people who primarily misuse cannabis. The main 10 treatments for opiate misuse are opiate substitution therapies (methadone and 11 buprenorphine), with stabilisation of the drug user being the treatment aim, 12 leading to improved physical health, well-being, social stabilisation and 13 reduced criminality and costs to society. There is also provision of harm- 14 reduction interventions, for example needle and syringe exchange facilities, 15 alongside formal drug treatment, aiming to minimise the health risks 16 resulting from illicit drug use to the individuals themselves as well as to 17 wider society. 18 19 Only a minority entering treatment choose abstinence initially and enforced 20 abstinence appears ineffective. However, approximately one third entering 21 treatment services generally are abstinent 5 years later (at least for a period of 22 time) (Gossop et al., 1998). 23 24 Despite the increase in treatment research, current UK practice is not 25 underpinned by a strong evidence base and there is wide variation in the 26 implementation of psychosocial treatment across services. Two factors may 27 contribute to this situation. First, practice tends to be influenced more by the 28 background and training of those delivering treatment within services than 29 by what research has shown to be effective. Second, there is a lack of studies 30 from the UK, with most evidence coming from the US. These studies will be 31 reviewed in Chapter 7. 32 33 The most common types of psychosocial interventions available in NHS 34 programmes specifically targeting drug-use behaviours, might be based on 35 one of a number of models, including cognitive-behavioural (including 36 motivational interviewing and relapse prevention), humanistic and 12-step 37 approaches (Wanigaratne, 2005). Often this is unfocused, and therapist and 38 client may not have a clear understanding of the therapeutic goals or 39 therapeutic method. In addition, there exist formal psychological therapies 40 delivered within adult mental health settings, aiming to address drug users’ 41 coexisting mental health problems (NTA, 2006). 42 43 In addition to formal, structured treatment, there is a long tradition in North 44 America and Europe of community-based, peer-led self-help groups for 45 people with substance misuse. The most well-established of these deliver the 46 principles of 12-steps, which has its origins in Alcoholics Anonymous (AA).

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1 Two such organisations especially relevant to people who misuse drugs are 2 Narcotics Anonymous (NA) and Cocaine Anonymous (CA). The 12-step 3 fellowships of AA and NA largely predate the existing drug treatment field as 4 a medical specialism. AA was founded in the USA in 1935 and in the UK in 5 1947. NA was founded in the USA in 1953, and the first UK meeting was held 6 in 1980 (White, 1998). 7 8 Brief interventions, typically empathic in nature and lasting up to two 9 sessions, have a variety of potential advantages in the treatment of drug 10 misuse, including ease of delivery and retaining drug users. These 11 interventions can be conducted in a variety of settings, opportunistically to 12 people not in formal drug treatment and as an adjunct to formal, structured 13 drug treatment (Ashton, 2005). Although brief interventions are considered to 14 be an important component of psychosocial treatment in open-access drug 15 services (for example, NTA, 2002, 2006), provision of such interventions varies 16 widely throughout England and Wales. 17 18 As previously mentioned, the mainstay of current UK drug treatment lies in 19 the pharmacological maintenance of dependent opiate users. Very little is 20 currently known or practiced in relation to managing the misuse of cocaine, 21 amphetamines or cannabis. Recent research on brief interventions provides 22 for potential development in this area, and is covered more extensively in 23 Chapter 7. 24 25 Needle and syringe exchange programmes, which provide injecting drug 26 users with clean injecting paraphernalia, have proven effective at helping to 27 reduce the risk of HIV/AIDS (Wodak, 2006). Some of these initiatives include 28 opportunities for psychosocial support alongside needle exchanges. Needle 29 and syringe exchange programmes have been established in all drug action 30 team regions in England, with the overwhelming majority providing 31 specialist services alongside pharmacy provision (NTA, 2006), although the 32 level of provision appears to be variable across regions and on average 33 appears to be insufficient to provide injecting drug users with a clean 34 needle/syringe for every instance of injection. Specialist services provide a 35 wider range of harm-reduction interventions (for example, on-site blood- 36 borne virus testing) than pharmacies, but it does not appear that service users 37 in all specialist services receive comprehensive harm-reduction support. 38 39 Residential rehabilitation programmes and therapeutic communities for the 40 treatment of drug problems are well established in the UK. These 41 programmes often have abstinence as their goal. They respond to the complex 42 problems related to the drug misuse of their residents by offering respite and 43 highly structured and intensive programmes of support and care as they seek 44 to make fundamental changes to the lifestyles of the residents, and treatment 45 in some programmes is lengthy, lasting 6–12 months (N TA, 2006). 46

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1 Most drug treatment is initiated as a result of drug users themselves seeking 2 treatment. However, there has recently been a rapid expansion in forms of 3 legally mandated treatment, whereby the person who misuses drugs is 4 mandated into treatment as an alternative or adjunct to criminal sanctions 5 (Wild et al., 2002). Such treatment may be legally ordered by the court or 6 through diversion away from the judicial process, usually following arrest 7 and charge for drug-related and other offences. Despite recent policy shifts of 8 diversion away from the courts, however, many people who misuse drugs 9 still serve prison sentences. A recent estimate suggests that around 39,000 10 prisoners with a serious drug problem are in custody at any one time (All- 11 Parliamentary Group on Prison Health, 2006). Within the prison setting, drug 12 misuse treatment is increasingly being offered following a number of recent 13 developments, including the phased transfer of responsibilities for 14 commissioning healthcare in publicly funded prisons from the Home Office to 15 the NHS (Department of Health, 2006c). Whilst the mainstay of treatment in 16 prison has traditionally been one of detoxification upon admission, there has 17 been a recent policy shift allowing increased access to opiate substitution 18 therapy and psychosocial interventions.

19 4.10 Service-user organisations 20 As outlined in Chapter 5, organisations for people who misuse drugs, such as 21 the 12-step fellowship of NA, were formed in the United States before the 22 drug treatment field had fully defined itself as a medical specialism. Many 23 rehabilitation centres in the US based themselves on the ‘concept houses’ that 24 developed out of AA. In this sense, drug services and service user 25 organisations have always been inextricably linked. However, since this time, 26 some service-user organisations have moved away from abstinence as the 27 ultimate goal to exploring harm minimisation and maintenance-oriented 28 therapies. 29 30 In the UK, service-user organisations have existed for almost 20 years. Some 31 of them developed in reaction to the poor service provided by drug treatment 32 centres in the 1970s. In the 1980s and 1990s, as harm reduction moved up the 33 agenda due to the advent of HIV and AIDS, organisations such as Drug 34 Dependents Anonymous and Mainliners were established. Although the 35 profile of such organisations is now in decline, there has been growth in 36 collaborations amongst clinicians, researchers and service users, most notably 37 in the UK Harm Reduction Alliance. In the late 1990s, there was a move 38 towards forming national drug organisations: the National Drug Users 39 Development Agency (NDUDA) and The Methadone Alliance (later called 40 The Alliance). 41 42 Recently, services have started to formally involve service users from such 43 organisations and take account of their experience. The National Treatment 44 Agency (NTA) was established as a special health authority to increase the 45 availability of drug treatment in the UK and improve its quality. From the

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1 outset, the NTA embraced user involvement as a central component of its 2 strategy. 3 4 Since the early 1980s service-user involvement in service provision has 5 developed considerably (see Chapter 5). User groups are now widespread in 6 the UK and are firmly established in the drug treatment field. 7

8 4.11 Economic impact of drug misuse 9 Drug misuse is a growing public health and health economics concern. 10 It is often associated with health and social costs as a result of transmission of 11 infectious disease, crime and violence (Petry et al., 2004). In a study of 1,127 12 AIDS cases reported in Philadelphia (USA), 40% were attributable to injection 13 drug use (Davis et al., 2005). It has been estimated that problematic drug use 14 accounts for annual economic and social costs in England and Wales of 15 approximately £13,750 million, or £35,455 per user, per year (Godfrey et al., 16 2002. In addition to the costs of crime, chronic health problems comprise a 17 significant element of the health and social care costs of drug misuse. For 18 example, the prevalence of HIV among injecting drug users is 4.2% (Judd et 19 al., 2005). The costs associated with HIV may have very little, if any, lag time 20 following the initial infection. Godfrey and colleagues (2002) estimated the 21 median per person annual cost of combination therapy at £13,381 for 22 asymptomatic, £14,222 for symptomatic and £24,314 for AIDS patients. These 23 estimates yielded median annual costs to the NHS of £12.5 million, £25 24 million and £24 million, respectively, totalling over £60 million. 25 26 In 1999, the reported prevalence of hepatitis B in injecting drug users was 27 estimated at 25% amongst those attending agencies in London and 17% 28 outside London, with a combined estimate for England and Wales of 21% 29 (Godfrey et al., 2002). Based on these estimates, the same study calculated that 30 the number of injecting drug users who were infected with hepatitis in 2002 31 was 53,975 (median estimate). An annual cost of £143 per year assumes a 32 lifetime cost of £4,300 to treat patients with hepatitis over their average life 33 expectancy of 30 additional years (Godfrey et al., 2002). The annual NHS 34 treatment cost of hepatitis B for injecting drug users was therefore calculated 35 at approximately £7.8 million (Godfrey et al., 2002). Similar estimates for 36 hepatitis C (based on a median 2002 estimate of 81,782 injecting drug users 37 with the virus) yielded an annual NHS treatment cost of £11.7 million (Ibid.) 38 (prevalence for HIV: 43.7% Judd et al., 2005). Beyond the healthcare costs 39 from the user, the neonatal NHS costs relating to drug misuse were calculated 40 at £4.3 million per year (Godfrey et al., 2002), with the annual cost of social 41 services in caring for these children amounting to £63 million. The same 42 authors estimated the median number of HIV positive injectors in England 43 and Wales at the time of 2002 to comprise 931 asymptomatic, 1,756 44 symptomatic and 1,007 AIDS individuals. Thus the health and cost burden 45 due to drug-related diseases is considerable.

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1 2 Including primary care, A&E, inpatient care, community mental health, and 3 inpatient mental health care, problem drug users are estimated to cost the 4 health service between£ 283 million and £ 509 million per year (Godfrey et al., 5 2002). This estimate was in addition to special, proactive addictive treatment 6 they may receive which at present costs £ 1,000 per user, per year, largely in 7 the form of psychosocial interventions (Godfrey et al., 2002). Furthermore, the 8 above estimates did not include the lost output of the victim or perpetrator, 9 long-term requirements for psychological care, nor the intangible effects on 10 the community at large such as security expenditure, property depreciation, 11 or increased reliance on private transportation. 12

13 4.12 Clinical practice recommendations

14 4.12.1.1 Healthcare professionals should, on initial contact with 15 services and at subsequent formal reviews, involve people who 16 misuse drugs in decision-making about their treatment and care. This 17 should include options for abstinence-oriented, maintenance-oriented 18 and harm-reduction interventions.

19 4.12.1.2 Healthcare professionals should ensure, when assessing and 20 developing a care plan, that the following issues are considered: 21 22 • a full assessment of medical, psychological, social and 23 occupational needs 24 • the history of drug use 25 • the experience of previous treatment (if any) 26 • the clarification of the service user’s goals in relation to his or 27 her drug use 28 • the service user’s treatment preferences.

29 4.12.1.3 Healthcare professionals who are responsible for the 30 delivery and monitoring of an agreed care plan should ensure that: 31 32 • an appropriate therapeutic relationship is established and 33 sustained 34 • the service user is helped to identify situations or states in 35 which he or she is vulnerable to drug use and to consider 36 alternative coping strategies 37 • full access to a wide range of appropriate healthcare services is 38 available to all service users 39 • maintaining engagement with the service remains a major 40 focus of the care plan 41 • effective liaison and collaboration with other care providers is 42 maintained.

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1 5 Service-user involvement and 2 experience, and impact on carers

3

4 5.1 Introduction 5 6 This chapter first offers an overview of the ways in which people who misuse 7 drugs have become involved in service user organisations and the ways in 8 which these organisations have intersected with and influenced drug 9 treatment services. The second part of the chapter describes some people’s 10 experiences of drug services and the final part looks at the impact of drug 11 misuse on carers. 12 13 The way that organisations for people who misuse drugs have become 14 involved in services reflects a general intention in health and social care to 15 take greater account of service-user experience in shaping the development of 16 services. With evidence that patient and public involvement improves 17 outcomes, service delivery and planning (Department of Health, 2004), 18 services are increasing their collaboration with service-user organisations, 19 individuals and carers. 20

21 5.2 Historical perspectives of service-user involvement 22

23 5.2.1 Introduction 24 This section offers a brief historical overview of service-user organisations 25 and the ways service-user experience has influenced drug misuse services, in 26 particular the contribution they are able to make to the development and 27 provision of services. Although service-user organisations have existed for 28 almost 20 years in the UK, it was not until recently that drug misuse services 29 have sought to involve such organisations. 30

31 5.2.2 12-step fellowships 32 The 12-step fellowships of Alcoholics Anonymous (AA) and Narcotics 33 Anonymous (NA) largely predate the existing drug treatment field as a 34 medical specialism. AA was founded in the USA in 1935 and in the UK in 35 1947. NA was founded in the USA in 1953, and the first UK meeting was held 36 in 1980 (White, 1998). 37 38 Although these fellowships are user-led organisations that are concerned with 39 the treatment and recovery of people suffering from a drug problem, they also

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1 provide a form of treatment in itself – a pathway to recovery, which may be 2 employed on its own, or as an adjunct to more formal treatment, as used in 3 the Minnesota Model (Kelly, 2003). 4 5 Until quite recently, people who misuse drugs who had an association with 6 the 12-step model tended to avoid the wider service user movement. There 7 are a number of possible reasons for this. The notion of anonymity is a core 8 concept in the 12-step fellowships and some members feel that open 9 involvement with service user groups can seriously jeopardise their 10 anonymity. Such concerns are often expressed alongside worries about the 11 potential for relapse in these circumstances, because members inevitably 12 come into contact with people who actively misuse illegal drugs. 13 14 Nevertheless, there have been voices within the 12-step fellowships 15 suggesting that wider involvement in service user organisations is possible 16 without breaching the 12 traditions, and this idea appears to be gaining some 17 support (White, 2000), with an increase in people with a 12-step background 18 actively engaging in the user organisations. The extent to which this 19 collaboration is successful appears to depend on the experience and 20 sophistication of those who are facilitating these events. Despite the points of 21 conflict between people recovering from dependency and people who are 22 actively using, when facilitators are able to keep participants focused upon 23 common goals, members of these two groups have been able to work together 24 effectively. An example where this collaborative working has flourished is the 25 ‘Experts by Experience’ programme, established in 1993. Now funded by the 26 National Treatment Agency for Substance Misuse (NTA) and facilitated by 27 the National Institute for Mental Health in England (NIMHE), this project has 28 sought to build the skill levels of service users and ex-users who are involved 29 in service improvement programmes. 30

31 5.2.3 Concept house residential rehabilitation programmes in the 32 USA 33 34 Concept houses, a form of residential rehabilitation programme organised 35 around a single ‘big idea’ or ‘concept’, grew out of AA. They were first 36 developed by an organisation called Synanon, founded in the mid-1950s by 37 Charles Diederich. A member of AA, Diederich was concerned about the 38 number of drug-dependent people turning up at AA meetings who were 39 being turned away. 40 41 Although Diederich and Synanon later fell into disrepute, many rehabilitation 42 centres in the USA based their programmes on the concept house’s model of 43 addiction and its theory and practice of treatment, namely confrontation and 44 ‘attack therapy’. As an indicator of motivation, prospective residents were 45 required to get on their knees and beg to be admitted. The encounter group

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1 became the basic treatment modality for rehabilitation programmes, in which 2 residents were expected to ‘confront’ others about their behaviour. Failure to 3 do so was regarded as a sign of relapse. Residents were forced to wear 4 humiliating signs around their necks in order to address some psychological 5 flaw, whether real or imagined. Services recruited staff almost exclusively 6 from their ex-residents. It was not until residential rehabilitation programmes 7 began to hire staff with professional qualifications — a practice that in some 8 areas did not start until the late 1980s and early 1990s — that these practices 9 began to change. 10 11 There has always been a fairly high level of representation of people with a 12 history of illicit drug use or with personal experience of dependence both 13 working in the field and occupying key decision-making roles in services. 14 Some members of this group advanced a model of drug use and drug 15 treatment that was based on the ideas that dependence is a disease that is 16 chronic, progressive and fatal, that people who are drug dependent have no 17 control over their drug use and that the only way to arrest the progress of the 18 ‘disease’ is through abstinence. However, this model of addiction is opposed 19 by the experience of people finding some stability through maintenance 20 therapy. 21

22 5.2.4 The birth of user involvement in services: the 1980s and 1990s 23 24 Current user involvement in services developed to some extent as a reaction 25 against drug treatment centres. In the 1970s, problems reported by service 26 users in rehabilitation centres could include: 27 28 • inappropriate and sometimes coercive or punitive treatment regimes 29 for chronic dependence 30 • encounter group sessions, where vulnerable women with a history of 31 sexual abuse were ‘confronted’ about their sexuality by a room full of 32 men 33 • vulnerable people being ejected from rehabilitation centres with no 34 means of support 35 36 In large areas of the UK there were also problems with outpatient treatment. 37 Treatment varied significantly in different clinics; in some, high doses of 38 opiates were dispensed without titration; in others, methadone maintenance 39 was unavailable. Twenty-eight-day detoxification programmes were 40 common, and so people went through repeated and often unsuccessful 41 detoxifications in an attempt to stay away from the black market and criminal 42 convictions for as long as possible. Prior to 1987, there were still large areas of 43 the country where no specialist drug treatment was available. 44

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1 These limitations of the services were a powerful impetus to the user 2 movement; the first signs of which became apparent in the mid-1980s. One 3 major catalyst was the publication of a number of articles by New York 4 researcher Sam Friedman, who had been working in Holland and had become 5 aware of the work of Nico Adriaans and the Rotterdam ‘Junkiebond’ or 6 Addicts’ Union (Friedman et al., 1987). In the early 1980s, Adriaans and his 7 group distributed clean syringes and needles throughout the streets and 8 dealing spots of Rotterdam in response to an outbreak of what would later be 9 identified as hepatitis C5. With the advent of HIV and AIDS, their work 10 became even more critical. As a consequence of their work, they were 11 regularly consulted by the local police and the city council on policy matters 12 and by the university, which employed them as fieldworkers/research 13 assistants. The idea spread to Amsterdam and various groups made the case 14 for a national Junkiebond (Trautmann, 2006). 15 16 In the UK, the arrival of HIV and AIDS meant that the public health priority 17 shifted, and the prevention of infection became more important than the 18 achievement of abstinence. Some ex-users who were working in the drug 19 treatment field found that the new model of ‘harm reduction’ gave them the 20 opportunity to articulate a different, more pragmatic model of drug 21 treatment. At the first International Conference on the Reduction of Drug 22 Related Harm, held in Liverpool in 1990, user involvement became a critical 23 part of the harm reduction agenda (Buning et al., 1992). A number of other 24 groups emerged at this time in the UK. They included: 25 26 • Drug Dependents Anonymous (DDA), a charity whose goals were to 27 help drug users and their families. The charity’s board of trustees was a 28 balance of users, families and other sympathetic local people. DDA 29 engaged in a wide range of activities, including needle exchange, 30 advocacy in treatment disputes, outreach work and community liaison 31 (DDA, 1989). 32 • Mainliners, another user-led organisation, was originally established in 33 1990 as a self-help and advocacy organisation for intravenous drug 34 users living with HIV. It rapidly gained a national profile in its original 35 form as a user-led charity, but after reorganisation it followed the 36 trajectory of the residential rehabilitation sector, as professional drugs 37 workers were employed and the organisation became a standard Tier-2 38 drug treatment provider. 39 40 By the mid 1990s, the idea of user involvement was becoming part of the 41 common parlance of drug treatment, particularly in harm reduction circles, 42 although there was no unifying force or organisation in the UK. If there was a

5 Hepatitis C was discovered in the early 1980s but was referred to as non-A and non-B hepatitis; only in 1989 was it properly identified as hepatitis C. Screening for it was developed in 1991. (http://www.hepcuk.info/data/usercontentroot/home/hepatitis%20c/Introduction.asp_

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1 single event that solidified the idea of service-user involvement as a viable 2 and coherent notion, it was an international meeting of a pan-European group 3 of service users. This meeting brought together representatives of user groups 4 from across Europe and put together a position paper on the human rights of 5 drug users in light of the AIDS epidemic, which was presented to the World 6 Health Organization and the European Commission. 7 8 This was to be the high point of user involvement in the 1990s, however; 9 throughout the rest of the decade, user-led organisations and user 10 involvement in general were in decline. Part of the reason was due to the 11 nature of drug dependence as an illegal and highly stigmatised activity. The 12 small group of users who had the skills and experience that would enable 13 them to be effective in user involvement activities tended also to have careers 14 that they were reluctant to put at risk by identifying themselves as users. 15 16 More recently there has been an emphasis on coalition working, in which 17 users and workers work collaboratively towards a common goal. Here a 18 notable success has been the UK Harm Reduction Alliance, a group of 19 clinicians, researchers and service users who are committed to raising the 20 profile of the harm reduction agenda in drug treatment and drug policy 21 (http://www.ukhra.org). Other examples include the work of Edith Springer 22 with the Clinton Peer AIDS Education Coalition (a group of sex workers and 23 treatment providers who became AIDS activists) and Crew 2000, a peer 24 coalition aimed at drugs education and harm reduction around dance drugs 25 in Edinburgh (McDermott et al., 1993). 26

27 5.2.5 User involvement today 28 29 Two groups, both of which had aspirations to be national drug user 30 organisations, emerged towards the end of the 1990s, were headed by drug 31 users with a long history of working in the drug treatment field. 32 33 The first of these was the National Drug Users Development Agency 34 (NDUDA) (Southwell, 2002). NDUDA aspired to be a central development 35 organisation that would co-ordinate and help in the development of all local 36 user involvement projects. With initial funding from Comic Relief, NDUDA 37 was also able to help local groups to obtain small grants that would be 38 sufficient to establish them in their area. The current user involvement 39 movement can be said to have evolved out of NDUDA. 40 41 The second, established at the same time as NDUDA, was The Methadone 42 Alliance http://www.m-alliance.org.uk), which sought to emulate the work 43 of the US organisation, the National Alliance of Methadone Advocates 44 (NAMA), the primary goal of which was to advocate for better treatment for 45 people receiving methadone maintenance treatment.

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1 2 NDUDA and The Methadone Alliance had entered into an informal non- 3 compete agreement. NDUDA would act as the focal point of all user groups 4 in the UK, while The Methadone Alliance would specialise solely in advocacy 5 needs. The Methadone Alliance later became The Alliance, following a 6 request from the NTA that it become more responsive to people with 7 advocacy needs in all areas of drug treatment. The Alliance has recently 8 secured Department of Health funding to enable it to employ six regional 9 advocates, thus securing national coverage. However, two years after being 10 funded by the NTA, organisational and management problems led to the 11 collapse of the NDUDA. 12 13 In 2002, the Audit Commission completed its assessment of drug treatment in 14 the UK and its findings echoed some of the views of people who had been 15 involved with the user movement. The Audit Commission found that: 16 17 • people had difficulty accessing drug treatment services in the UK 18 • there were long waiting times and limited options for treatment 19 • there was a lack of staff training and expertise 20 • treatment did not always follow good practice 21 • there was suboptimal dosing for patients receiving pharmacotherapy 22 (Audit Commission, 2002). 23 24 Perhaps in anticipation of this report, the government established the NTA in 25 2001. The NTA is a special health authority tasked with increasing the 26 availability of drug treatment in the UK and with improving its quality. From 27 the very beginning, the NTA embraced user involvement as a core component 28 of its strategy (Best et al., 2006). By placing user involvement at the heart of its 29 strategy for improving drug treatment in the UK, the NTA has managed to 30 make it an integral part of the drug treatment landscape in the UK. Since its 31 foundation, the NTA has: 32 33 • established the National Users Advisory Group 34 • established a user forum in each of the nine NTA regions 35 • ensured that service user involvement is a component of each of the 36 NTA’s activities at every level, including representation on the NTA 37 board 38 • issued guidance to local providers and drug action teams on how to 39 implement user involvement projects 40 • made progress on user involvement one of its performance indicators 41 for local Drug Action Teams. 42 43 Despite its achievements, the NTA’s efforts in the user involvement arena 44 have been criticised by some (Audit Commission, 2004). A subsequent follow-

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1 up report in 2004 by the Audit Commission suggested that the drug treatment 2 field needed to improve its user focus and put in place a strategy that 3 provided: 4 5 • a system for incorporating user and carer views into the development 6 of national policy 7 • effective national and regional structures that involve users and carers 8 in planning and performance management 9 • easy access to the wealth of advice on community and user 10 engagement and opportunities for peer support (Audit Commission, 11 2004). 12 13 In the last year, a new national user organisation, the National Users Network 14 was established to replace the NTA’s National User Advisory Group in 15 response to the regionalisation of many of the NTA’s functions. This 16 organisation is expected to fulfil a similar role to that originally envisaged for 17 NDUDA. 18 19 Over the last 30 years, service-user involvement in drug treatment has 20 developed considerably in the UK. User groups now exist in most areas of the 21 UK, though they remain patchy in many, and they still face many challenges, 22 which are predominantly developmental and resource focused. However, the 23 principle is now firmly established within the drug treatment field. 24

25 5.3 Service-user experience of services 26 This section provides an overview of ‘treatment journeys’ based both on 27 interviews conducted by Salter and colleagues and excerpts taken from 28 personal stories on the WIRED website 29 (http://www.wiredinitiative.com/research-addiction.htm). It reviews 30 experiences of inpatient treatment and service-user perceptions of abstinence 31 and maintenance.

32 5.3.1 Treatment journeys 33 Salter and colleagues conducted semi-structured interviews with 15 service 34 users regarding their experiences of dependence and recovery. The sample 35 comprised individuals either in treatment or those using aftercare services. A 36 grounded theory analysis was performed, from which seven dominant 37 themes emerged: the nature of dependence and its development, the 38 reasons/factors for use, the negative effects of use, the process of realisation, 39 behaviour change, treatment and recovery. While it is helpful to identify 40 common themes that emerge, treatment journeys are highly individual 41 experiences and it should be borne in mind that the following is based on 42 experiences from only 15 service users. 43 44 Reasons for use

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1 In the sample, initial contact and experimentation with drugs were attributed 2 to social pressure (‘We always used to try everything together; ‘I wanted to be part 3 of something’) and as an aid to dealing with personal circumstances such as 4 bereavement (Heroin ‘took everything away’). The decision to continue using 5 was associated with the search for a ‘buzz’, but this eventually led towards 6 more excessive use in order to avoid withdrawal symptoms: 7 8 ‘It becomes a need. It changes from a craving to a complete obsession where 9 you are thinking about it constantly.’ 10 11 ‘The most important thing on your mind is to make yourself better so the first 12 thing you do is go out and score.’ 13 14 ‘I don’t want to be turkeying, so I’m going to keep taking these drugs…as long 15 as I’ve had my drugs in the morning I can still do a day’s work.’ 16 17 18 Nature of dependence 19 A common theme that emerged in the personal accounts was that individuals 20 experienced a rapid acceleration in their drug misuse that eventually led to 21 them feeling ‘controlled’ by the drug. There was also some recognition of 22 drug misuse as a ‘disease’: 23 24 ‘…It just spiralled out of control; it just went mad.’ 25 26 ‘The disease can take over and control you, manipulate you as a person. And 27 you can manipulate others around you when you’re under the influence of 28 alcohol or drugs; it’s very, very powerful…’ 29 30 ‘There was no way out…I could see no way out of this…I felt there was 31 absolutely nothing I could do; I thought I was going to die…’ 32 33 Service users acknowledged that heroin in particular is a highly addictive 34 drug, although many initially reported not knowing this: ‘It’s taken me until 35 now to realise how powerful addiction is’. 36 37 Negative effects of use 38 The personal accounts suggested that drug use affects the individual in a 39 number of negative ways: it can lead to physical and emotional/ 40 psychological problems, breakdown in relationships, social exclusion and 41 employment difficulties. 42 43 Physical effects 44 Although physical health problems are common in people who misuse drugs, 45 the need for the drug may militate against any concerns the individual may 46 have about his or her health: 47

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1 ‘I knew that I was ill. My chest was killing and I had a constant cough, but I 2 didn’t care.’ 3 4 ‘The main thing is physically I have days where I wake up and I feel like I’ve 5 done 10 rounds with Mike Tyson; my body feels totally battered, aching all 6 over.’ 7 8 Emotional/psychological effects 9 The testimonies suggest that some people use drugs as a means of coping 10 with emotional or psychological problems, only to find that drug misuse 11 exacerbates the problem: 12 13 ‘My mental health suffered as well. As long as I was blocking stuff out with 14 the substance, I wasn’t dealing with it, so the problems were getting worse all 15 the time. It’s not that it’s not getting better, it’s getting worse.’ 16 17 ‘You don’t have emotions when you’re on gear. Emotions don’t even come into 18 the equation.’ 19 20 Relationships and social exclusion 21 Long-term drug use can have devastating effects upon the family, leading to 22 the individual feeling excluded from the family unit or culminating in him or 23 her leaving home: 24 25 ‘It’s really hurt my family. My mum washed her hands of me saying “we’ve done 26 everything we can for him and he doesn’t want to help himself”.’ 27 28 Not understanding the nature of dependence may cause the person who 29 misuses drugs to feel that he or she is the only person with a problem: 30 31 ‘I felt isolated; I thought I was the only one who ever felt the way I felt. I thought that 32 nobody could understand me’. 33 34 Within drug communities, there may also be a sense of isolation: 35 36 ‘Gear causes a lot of arguments and you end up falling out with everybody…you 37 become really greedy; you don’t want to share with your mates. I became really 38 selfish.’ 39 40 Employment 41 Long-term drug misuse may cause serious employment problems, leading to 42 unemployment or preventing the person from finding a job: 43 44 ‘I was always in the manager’s office. I started to take every Monday off, a long 45 weekend, then I started to take every Friday off long weekend, and then I ended going 46 in two days a week, and the rest of the time getting stoned’. 47

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1 Process of realisation about dependence 2 In the early stages of dependence, service users were unaware of their 3 dependence or chose to ignore it: 4 5 ‘I didn’t see it as a problem; it was other people around me that saw it as a 6 problem.’ 7 8 ‘I knew inside that I had a problem, but I didn’t want to admit it so I just 9 carried on.’ 10 11 Some individuals only came to realise the true extent of their dependence 12 when they experienced withdrawal symptoms; however, this did not 13 necessarily result in acceptance of the problem: 14 15 ‘I remember the day of having physical withdrawals and that’s when I knew I 16 needed it.’ 17 18 ‘It dawned on me that I had a problem, but finding the solution didn’t really 19 come until my parents found out.’ 20 21 Recognition of the problem can also occur as the dependence progresses: 22 23 ‘The deeper into my addiction I’ve got, the more I’ve realised I have a 24 problem.’ 25 26 ‘I completely blocked things out. It’s only now that I’m in rehab that I’ve got a 27 clear head to be able handle what was going on then. At the time, I tried hard 28 not to think about it – I just used more and more.’ 29 30 Acceptance of the problem came to many when their drug misuse adversely 31 affected members of their family and, in particular, their children: 32 33 ‘I was doing it 50-50 for myself and my parents. I didn’t want to have to put 34 them through any more and I could see the state of myself.’ 35 36 ‘I was getting to realise that I didn’t really know my family anymore and that 37 I must have spent longer away from them and a lot longer off my face on one 38 thing or another….I started to notice that gradually and then it hit me full on 39 since I’ve been in [treatment]; I realised that I was losing touch with them.’ 40 41 Behaviour change 42 A common theme emerging from the personal accounts was that individuals 43 felt that they had to reach a crisis point before engaging in behaviour change: 44 45 ‘You’ve just got to hit rock bottom basically before you decide that you’ve got 46 to stop doing this to yourself.’ 47

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1 ‘I couldn’t go any lower; the only way was up.’ 2 3 ‘I had to get out of injecting it because I knew that I would die.’ 4 5 Some patients reached a stage whereby treatment was the only option: 6 ‘I was too ill not to go [for treatment]…’ 7 8 Treatment 9 Many participants perceived treatment to be an opportunity for a fresh start: 10 11 ‘It gives you a chance to start again; you’ve got a new chance at life now to 12 start again from scratch…I’m going back to college, getting my own place, 13 getting a job… and starting again…’ 14 15 Some individuals were aware that they needed to be ready and motivated to 16 access treatment in order for it to be effective: 17 18 ‘You have to actually seek treatment. It’s up to them if they want to start…If a 19 person’s not ready, they’re not ready.’ 20 21 ‘My true feeling is that you have to do it for yourself.’ 22 23 However, participants perceived the long waiting times to be an obstacle in 24 accessing treatment: 25 26 ‘I’d go with all the intentions to get off it…but the longer you have to wait, the 27 more and more trouble you get in. Eight months is a long time; you don’t 28 know what is going to happen to you.’ 29 30 Participants reported that, once they accessed treatment, they became more 31 aware of their dependence as a problem and began to ask for help, which 32 facilitated recovery: 33 34 ‘I’ve been taught to empty your closet…that’s one thing I’ve never done is 35 gone up to somebody and told them my problems…now I’m learning to go and 36 ask for help. It’s not that bad asking for help; it’s not going to kill you.’ 37 38 During treatment, participants were able to learn about the nature of their 39 dependence and how to alter their drug-using lifestyles in order to deter 40 further drug misuse: 41 42 ‘I’ve come here to learn how to deal with these problems without having to 43 turn to drugs.’ 44 45 ‘I’ve learnt how it all works for you – how it makes your body and how it 46 makes you feel.’ 47

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1 Participants were also aware that treatment requires active engagement and a 2 complete change in mindset: 3 4 ‘You get out of it what you put in. If you don’t put anything in, you don’t get 5 anything out.’ 6 7 ‘You’ve got to be willing to change everything – your behaviour, your thought 8 patterns. It’s not just about putting a drink or drug down, it’s about changing 9 your life.’ 10 11 Recovery 12 Treatment was perceived as a crucial tool aiding recovery as it provides a 13 ‘safe’ area, in which participants can meet people in similar situations, and 14 therefore reduces isolation: 15 16 ‘I needed treatment. I tried to do it myself and it just didn’t work and I felt 17 very alone doing it myself because I couldn’t really talk to people about how I 18 was feeling and how awful I felt…they’ve not been in the same boat and they 19 don’t understand…’

20 5.3.2 Access to help and services, and early contact 21 The following extracts are taken from personal stories on the WIRED website 22 and demonstrate that, although treatment can successfully reduce drug use 23 and lead to abstinence, some service users reported that they did not receive 24 adequate help when trying to access services: 25 26 ‘I went to every doctor’s…everywhere. But we’re smack heads, “See the door, 27 close it on the way out, fuck off”. That’s all we got…them days…I was asking 28 for methadone, that was all. I wasn’t asking for valies [valium] or temazies 29 [temazepam] or anything…You get sick of asking for help and not getting 30 any.’ 31 32 Service users expressed concern over the delay in accessing treatment and 33 how this can lead to criminal behaviour, return to drug misuse and can have a 34 negative impact on seeking further treatment: 35 36 ‘In them days, you’d have to wait up to a year for help and in that time you 37 could have stolen millions of pounds worth of items’. 38 39 ‘I was trying to get help from loads of drug agencies and they were like, 40 “Sorry, we can’t help you for four months, we’ve already got people on our 41 books”. I thought “I can’t carry on like this for 4 months, it’s going to be easier 42 to end it”. I think that’s what one of the big problems is. Help not being 43 available, when you need it. There were times where I’d get into a really bad 44 way, try and get help and couldn’t get it. And then when the help comes 45 around you’ve usually got a bit of money and you think, ‘I’m not ready to quit 46 now.’

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1 2 ‘I’ve been waiting to change for a long time, especially the last two years. 3 We’re all crying out for help and people just think if they give you a 4 methadone script you’ll shut up and go away, but it ain’t that easy…And then 5 you’re like “Oh yeah, I’ll have a bit of gear, one bit won’t hurt.” But it’s never 6 just one, is it?...You ask anyone.’ 7 8 It was not uncommon for service users to report being unaware of treatment 9 facilities open to them. In some cases, the person or his or her family would be 10 the ones who actively sought out options: 11 12 ‘Even going to the doctors, you’d walk in and, as soon as you told them what 13 the problem was, they’d have you out the door. It dawned on me that I had a 14 problem, but finding the solution didn’t really come until my parents found 15 out.’ [After hours of ‘trawling’ through the Yellow Pages, Stephen’s 16 parents contacted the NHS helpline, which put them in touch with a 17 local drug agency.] 18 19 Accessing treatment in the prison setting was perceived by some service users 20 as problematic due to their experience that little help or support was offered 21 and hearing that: 22 23 ‘CARAT [counselling, advice, referral, assessment and throughcare] workers’ visits 24 were infrequent and not very helpful’. 25 26 However, for others the prison setting was seen as a fast-track to accessing 27 services: 28 29 ‘I reached the point where he believed prison was the “best bet” because of the 30 strict routine imposed there.’ 31 32 Due to the strain on resources and limited spaces available in different 33 treatment settings, some patients experienced being turned away from 34 services: 35 36 ‘I really thought I was going to get off it, but I was told that I was going to 37 have to wait a month for an appointment. When I went for that appointment 38 they said I wasn’t on it too badly so there wasn’t a rush for me to be seen; it 39 was going to take over 6 months.’ 40 41 Conversely, for some service users the obstacle to accessing treatment was 42 fear of involving social services with regards to their children: 43 44 ‘I used to work around the children so that I could pick them up from school 45 and make dinner and things like that…I was worried what would happen to 46 the children if I went to get help…so I just stayed on it, so I could get up in 47 the morning and get the kids to school.’

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1

2 5.3.3 Inpatient treatment 3 4 There is very limited research on users’ perceptions of inpatient programmes 5 and therapeutic aspects of treatment (Bacchus et al., 1999). Through semi- 6 structured interviews with 42 drug users receiving inpatient treatment, 7 Bacchus and colleagues (1999) found that patients acknowledged the high 8 demand for the service and were therefore generally satisfied with pre- 9 admittance waiting times. However, some clients reported that, during the 10 waiting period, their motivation to cease drug misuse decreased, and 11 continued exposure to drug-using friends increased social pressure to 12 maintain use. Clients – and especially parents who misuse drugs – wished to 13 receive more support and visits from family, though some felt the treatment 14 environment was not appropriate for their young children. Most clients were 15 able to develop a rapport with their key worker, which motivated patients to 16 achieve or maintain abstinence for fear of letting him or her down. 17 Befriending and supporting other new patients was also conducive to 18 abstinence maintenance and increased self-esteem, and the independent 19 thinking involved in this role often operated as a marker of self-improvement. 20 Attending an inpatient service also offered opportunities for self-reflection 21 and reassessment. 62% of clients had made prior arrangements for aftercare, 22 thus demonstrating their desire to maintain abstinence (Bacchus et al., 1999).

23 5.3.4 Service-user perceptions of abstinence and maintenance 24 treatment 25 26 Several authors have investigated drug users’ perceptions of treatment 27 services, their opinions of healthcare delivery and reasons for seeking 28 treatment. McKegany and colleagues (2004) investigated drug users’ reasons 29 for seeking treatment: specifically, whether treatment was sought to reduce 30 risk behaviour or to become abstinent from drug use. Eighty-two per cent of 31 the sample cited becoming abstinent and achieving stabilisation as their aim, 32 with 57% of the sample attending a drug agency primarily to achieve 33 abstinence. Patients expressed a preference for non-methadone drugs, thereby 34 further demonstrating their desire to become abstinent. Very few people who 35 misuse drugs cited harm-reduction outcomes, such as reduced use, 36 stabilisation or safer use, as the only change they desired. This suggests that 37 people who misuse drugs who approach treatment services have reached a 38 stage whereby they no longer want to misuse drugs. Similar results were 39 reported in the NTA service-user satisfaction survey conducted in 2005. This 40 revealed that users of prescribed methadone were more likely, when 41 compared with users of heroin, cocaine and crack cocaine, to be satisfied with 42 their level of use, but 50% wanted to stop completely and just over 10% 43 wanted to reduce their use (Best et al., 2006). 44

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1 A self-report questionnaire administered by Clarke and Wilkes (1997) found 2 that, of a sample of 70 drug misusing clients, the primary reason for seeking 3 help was being ‘fed up’ with using (78%), followed by concerns for family 4 (72%), money worries (61%) and health problems (57%). These findings 5 suggest that, after a certain length of drug misuse, clients become frustrated 6 with their lifestyles and seek treatment to change their current behaviour. 7 This sample was comprised of individuals receiving methadone maintenance. 8 Thus, the most frequently desired service was receiving methadone 9 prescriptions, and 82% reported being satisfied with the service they were 10 receiving. However, 20% of the sample did express a wish to receive a quick 11 detoxification, which suggests that some methadone users would rather 12 achieve total abstinence than be maintained on methadone (Clarke & Wilkes, 13 1997). 14 15 A significant proportion of people who misuse drugs in the UK currently 16 receive methadone maintenance treatment, and therefore it is important to 17 examine users’ perceptions of the effectiveness of such treatment. Neal (1998) 18 conducted semi-structured, qualitative in-depth interviews with 80 people 19 who misuse drugs currently receiving prescribed methadone. Clients 20 expressed mixed views on methadone: 45% felt that prescribed methadone 21 had improved their emotional and physical well-being in terms of reduced 22 painful withdrawal symptoms and sleep facilitation. However, a similar 23 percentage (43%) also reported experiencing negative health effects while on 24 methadone, in particular damaged teeth, weight problems (gains or losses), 25 stiffness and soreness. Moreover, there was widespread recognition that 26 methadone is simply a substitution of one drug (heroin) for another highly 27 addictive substance that produces similarly bad withdrawal symptoms when 28 people attempt to discontinue use (Neal, 1998). Another common criticism 29 was that being on methadone scripts is very time consuming, as the script 30 must be collected on a daily basis. For many, this restricts the opportunity to 31 perform a regular job. Conversely, while employment opportunities are not 32 necessarily enhanced, people perceive themselves to be in a better financial 33 situation as they may no longer have to sell their personal belongings or 34 accrue debts to finance an illicit drug habit. 35

36 5.4 Impact of drug misuse on carers 37 38 There is an increasing recognition that drug misuse affects the entire family 39 and the communities in which these families live. For example, the Home 40 Office’s updated Drug Strategy (2002) includes targets on increasing access to 41 help, advice and counselling for parents, carers and families of people who 42 misuse drugs. Additionally, the NTA user satisfaction survey found that 25% 43 of respondents felt that staff did not offer families and carers enough support 44 (Best et al., 2006). 45

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1 There has also been a growth in carer organisations, most notably ADFAM 2 and Families Anonymous (FA), for carers of people who misuse drugs and 3 over 100 peer support family groups in the UK founded on parents own 4 experience of drug use in their families. ADFAM evolved in the mid 1980s 5 after a distressed mother of a drug user found that there were no support 6 services to assist and advise her regarding her child’s drug problem. The main 7 ethos of the service is to provide support, training and advocacy for families 8 of drug and alcohol users. It also informs the government about patient and 9 family needs and challenges policy makers, decision makers and the media to 10 better represent and understand the issues facing families of drug users. 11 ADFAM has undergone marked development over the past two decades, 12 during which it has provided a nationwide helpline service (which closed in 13 2002), added training and criminal justice work to the service in the 1990s and 1514 re cently expanded its community development team. 16 Families Anonymous (FA) is a self-help service base on the 12-steps and is 17 aimed at helping families affected by drug use and behavioural problems. 18 Families attend meetings on a regular basis and share their experiences with 19 other families. Through these meetings family members are able to support 20 one another and overcome some of the issues they face. Families also learn 21 that their behaviour may enable drug users to persist in drug use, for example 22 protecting the person who misuses drugs from the consequences of 23 dependence may encourage him or her to continue negative drug behaviours. 24 FA originated in Los Angeles in 1971, and was introduced to the UK in 1980. 25 Like ADFAM it has also expanded in recent years, with approximately 50 26 groups running throughout the UK at present and have services worldwide. 27 28 However, despite the recognition of carers’ needs and the growth of carer 29 organisations, there is a rather limited evidence base assessing the impact on 30 carers/families of drug misuse, on interventions intended to support them, 31 and even less attention given to the needs of the family/carer in their own 32 right. Most interventions have targeted carers/families primarily to improve 33 outcomes of the person who misuses drugs and only secondarily to address 34 the needs of the family. Bancroft and colleagues (2002) noted that there is a 35 division in the literature between those who consider drug misuse ‘a problem 36 for the family’ and those who consider it ‘a problem of the family’. Taking the 37 latter approach may result in the carer or family member feeling stigmatised 38 and less likely to seek professional help. 39 40 There is a need to assess the impact on family members and carers of people 41 who misuse drugs in order to identify the challenges they face and to evaluate 42 the most effective ways to offer help and support to them. Velleman and 43 colleagues’ (1993) report of 50 close relatives of people who misuse drugs 44 suggested a strong psychological (for example, feelings of loneliness, 45 isolation, anxiety and depression) and physical (including raised blood 46 pressure, ulcers, and so on) impact on families/carers. Hudson and colleagues 47 (2002) assessed the social adjustment of 65 female family members and

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1 significant others of people who misuse drugs using the Social Adjustment 2 Scale — Self-Report (SAS-SR; Weismann & Bothwell, 1976). They compared 3 SAS-SR scores for family members and significant others of people who 4 misuse drugs with ‘standard’ control conditions derived from two other 5 published studies (Rorty et al., 1999; Weissman et al., 1978). Family members 6 and significant others of people who misuse drugs were found to have greater 7 difficulties in relation to social, work, social/leisure and extended family 8 adjustment than a ‘standard’ comparison group. However, the rather 9 problematic nature of the comparison group (derived from other studies with 10 clear geographical and temporal differences) limits the ability to make a 11 genuine comparison between the two groups. 12 13 It appears the impact on family members may differ depending on the roles 14 and responsibilities within the family. Lewis and Williams (1994), in their 15 study of a family support group for African-American grandparents, found 16 that grandparents often took the role of primary carer for their grandchildren 17 because their children had difficulties fulfilling parental responsibilities, due 18 to drug misuse, serving jail sentences, and so on. This sometimes resulted in 19 financial problems as government funding for childcare was not always 20 passed on to the grandparents. Velleman and colleagues (1993) found 21 partners were more likely to report physical violence, threatening behaviour 22 and pressure for money, while parents were more likely to report lying, 23 manipulation and self-neglect by the person who misuses drugs. Hudson and 24 colleagues (2002) also compared the experiences of partners and parents of 25 people who misuse drugs and found that partners tended to have slightly 26 greater adjustment problems than parents of people who misuse drugs. The 27 main difference appeared to be financial, with partners of drug users 28 experiencing greater financial problems than parents. 29 30 Adfam’s (2002) report identified a number of needs for families of people who 31 misuse drugs and alcohol. One of the major needs reported by families was 32 the need to cope with stigma. It was argued that stigma was a major barrier in 33 preventing carers or family members from accessing services both in terms of 34 actual exclusion from primary care services as well as self-exclusion through 35 fear of being judged. A further need was to access services. Provision of 36 services for families of people who misuse drugs was found to be rather 37 limited (see also Bancroft, 2002), but even where these services were available, 38 many families were either not aware of them or how to access them. Many 39 families also perceived themselves to be excluded from participation in the 40 treatment provided for their family member. Some families felt that workers 41 were hiding behind confidentiality when they could have provided general 42 information about treatment. 43

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1 5.4.1 Clinical practice recommendations

2 5.4.1.1 Healthcare professionals should explore with people who 3 misuse drugs whether to involve their families and carers in 4 assessment and treatment plans, ensuring that the service user’s right 5 to confidentiality is respected.

6 5.4.1.2 When in contact with family members or carers of people 7 who misuse drugs, all healthcare professionals should: 8 • enquire about family and carer concerns in relation to the 9 impact of drug misuse on their lives and relationships 10 • provide verbal and written information and education on the 11 impact of drug misuse on service users, families and carers.

12 5.4.1.3 Healthcare professionals should make themselves accessible 13 to family members and carers if appropriate. The needs of family 14 members and carers should be taken into account, including: 15 • the welfare of dependent children, siblings and vulnerable 16 adults 17 • a regular assessment of carers’ personal, social and mental 18 health needs. 19 20

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1 6 Identification and recognition

2 6.1 Introduction

3 6.1.1 Defining screening and identification 4 Screening has been defined as the systematic application of a test or enquiry 5 to identify individuals at high risk of developing a specific disorder who may 6 benefit from further investigation or preventative action (Peckham & 7 Dezateux, 1998). Screening programmes detect people who have the condition 8 or at risk of developing the condition in the future. They do not establish a 9 diagnosis but give some indication of any action that may be required, such as 10 further diagnostic investigation, closer monitoring or even preventative 11 action. Screening is not necessarily a benign process (Marteau, 1989). Since 12 screening tools may never be 100% accurate, people who are incorrectly 13 identified as being at risk of developing a condition (false positives) can be 14 subject to further possibly intrusive, harmful or inappropriate investigations, 15 management or treatment. Those falsely identified as not being at risk of 16 developing a condition (false negatives) will also suffer by not being given the 17 opportunity to undergo the further investigations that are needed. 18 19 The National Screening Committee (NSC), in its guidance for determining 20 whether a national screening programme should be undertaken for any 21 disorder, has set 22 criteria for appraising the viability, effectiveness and 22 appropriateness of a programme for large population screening (NSC, 2003). 23 These include: the need for a simple, safe, precise and validated screening 24 test; an agreed policy on the further evaluation of individuals with a positive 25 test result; the availability of an effective intervention for those identified 26 through early detection, with evidence of early treatment leading to better 27 outcomes than later treatment; adequate resources available prior to 28 commencement; and acceptability to the population. It is important that the 29 majority of these criteria are satisfied before a screening programme is 30 adopted, not least because screening can cause adverse effects, including 31 distress secondary to asking specific questions, raising concerns and raising 32 expectations of care. 33 34 Existing NICE mental health guidelines have considered the case for general 35 population screening for a number of mental health disorders and concluded 36 that screening should only occur for specific high-risk populations where 37 benefits outweigh risks (for example, NICE, 2004, 2005). 38 39 Screening has two main functions: identification and prediction. For the 40 purpose of this guideline, identification refers to the detection of current drug 41 misuse. Prediction refers to the detection of risk factors, either current or past, 42 that increase the probability of developing drug misuse. This chapter will

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1 only be addressing identification of current drug misuse, as prediction lies 2 outside of the current scope. 3 4 Additionally, this chapter distinguishes between methods to identify drug 5 misuse and tools used to provide comprehensive clinical assessment of drug 6 misuse. The latter are again outside of the scope but are covered in greater 7 detail in the NICE clinical guideline Drug Misuse - Detoxification (NICE, in 8 press).

9 Prevalence of drug use 10 As was described in Chapter 4, the British Crime Survey 2005/06 (Roe & Man, 11 2006) estimated that 34.9% of 16–59 year olds had used one or more illicit 12 drugs in their lifetime, 10.5% had used one or more in the past year and 6.3% 13 in the past month. Cannabis was the most widely used drug; 8.7% of 16–59 14 year olds reported using this drug in the last year. Cocaine was the next most 15 commonly used drug; 2.4% reported using either cocaine powder or crack 16 cocaine in the past year. This was followed by ecstasy at 1.6% and 17 amphetamines at 1.3%. Heroin use was much lower, with 0.1% reportedly 18 using opiates in the past year. The large majority of these individuals do not 19 present to drug treatment services, but they do present to acute medical 20 services, the criminal justice system and social care agencies, often as a 21 consequence of the drug misuse (Crome, in press). Effective methods are 22 needed to identify people who misuse drugs therefore may have value in 23 promoting access to appropriate treatment services. This chapter will not deal 24 with the use of large scale screening/identification tools the workplace, 25 schools and sport, which is beyond the scope of the guideline. It will be 26 restricted to identification of at-risk populations in health, social care and 27 criminal justice settings.

28 Current practice 29 Routine screening for drug misuse in the UK is largely restricted to criminal 30 justice settings, including police custody and prisons (Matrix Research and 31 Consultancy & NACRO, 2004). In health and social care settings, however, the 32 use of methods for identification and recognition is sparse. Initiatives are 33 underway to introduce routine or targeted screening for alcohol misuse in 34 health and criminal justice settings as part of the National Alcohol Harm 35 Reduction Strategy (Prime Minister’s Strategy Unit, 2004) and the public 36 health strategy (DH, 2004). A recent study of psychiatric inpatients in London 37 found that only 1 in 50 patients admitted to a teaching hospital had 38 undergone screening for drug misuse (Barnaby et al., 2003). The updated 39 Models of Care service framework emphasises the importance of non- 40 specialist (Tier 1) services in the identification of drug misuse as a precursor 41 to referral for treatment (NTA, 2006a). However, most of these programmes 42 are in the early stages of development and there is a clear need for 43 improvement of identification methods for drug misuse in the UK.

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1 6.2 Identification tools 2 There are a range of tools for identifying drug misuse including routine 3 clinical enquiry (where the clinician asks questions about whether an 4 individual uses drugs, and if appropriate, frequency and consequences of this 5 use) , questionnaires (paper and pencil tests, based either on clinician rating 6 or self-report, to assess if an individual meets certain criteria for dependence 7 or abuse of drugs) biological testing (biological testing of urine, oral fluid or 8 hair samples to assess if a person has used certain drugs within a certain 9 period of time). 10 11 The key measures of effectiveness of a drug misuse identification instrument 12 are generally considered to be sensitivity (the probability that someone with 13 drug dependence will have tested positive), specificity (the probability that 14 someone without drug dependence will have tested negative), the positive 15 predictive value (the probability that someone with a positive test result will 16 receive a diagnosis of drug dependence), the negative predictive value (the 17 probability that someone with a negative test result will not receive a 18 diagnosis of drug dependence) and overall efficiency (percentage of cases 19 correctly classified by the test as having or not being dependent). A good test 20 will have good results on all these different measures. The relative value 21 placed on each measure in determining which test to use is based on several 22 factors, including the prevalence of the disorder among the group being 23 considered and the risks of missing a diagnosis. It can be argued that the 24 positive predictive value is of particular importance. As the prevalence of a 25 condition reduces, so does the positive predictive value, i.e. there are more 26 individuals who have screened positive but do not have the condition (false 27 positives).

28 6.2.1 Identification questionnaires 29 Several identification questionnaires have been developed to identify drug 30 misuse. These may be of potential use for identifying drug misuse in at-risk 31 populations. Only questionnaires of fewer than 30 items, validated against a 32 structured interview that yielded a diagnosis of drug abuse/dependence were 33 included in this review. Eight studies reviewed below met the eligibility 34 criteria. These studies were evaluated in terms of psychometric effectiveness 35 (sensitivity, specificity, positive predictive value and negative predictive 36 value); feasibility for use in health, social and criminal justice settings; and 37 relevance to UK context.

38 Clinician-rated questionnaires for adult populations 39 The Drug Use Disorders Identification Test (DUDIT; Berman et al., 2005) is 40 based on the World Health Organization’s validated and widely used Alcohol 41 Use Disorders Identification Test (AUDIT; Babor et al., 2001). DUDIT consists 42 of 11 clinician-rated items covering domains of drug consumption, 43 dependence and problems associated with use. It has been validated in a

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1 Swedish drug-using population, and in that context had an acceptable level of 2 sensitivity (90%) but not specificity (78%) (Berman et al., 2005). 3 4 The CAGE questionnaire has been adapted to include drugs (CAGE-AID; 5 Brown & Rounds, 1995). CAGE was originally developed to identify alcohol 6 misuse and in that context has an acceptable sensitivity and specificity. 7 Among a general hospital population, three of the four items of the clinician- 8 rated CAGE-AID had fairly low sensitivity (71%) and specificity (76%) 9 (Brown et al., 1998). 10 11 The Chemical Use Abuse and Dependency (CUAD) scale is clinician rated 12 and has been developed and used in psychiatric populations (McGovern & 13 Morrison, 1992). A validation study found high sensitivity (88%) and 14 specificity (93%) (Appleby et al., 1997). Also used in psychiatric populations is 15 the Dartmouth Assessment of Lifestyle Instrument (DALI), an 18-item 16 clinician-rated scale concerned mainly with alcohol, cocaine and cannabis use 17 (Rosenberg et al., 1998). The items for alcohol and drug use were analysed 18 separately; the items designed to measure cannabis and cocaine use had a 19 sensitivity of 80% and a specificity of 100%. 20 21 Of the questionnaires discussed above, DUDIT had the highest sensitivity and 22 specificity and was also relatively quick to administer (11-items). 23 However, this has not been validated outside of a known drug-using 24 population and would require further research before it can be recommended 25 for general use in the UK. It is also important to note that most of the other 26 questionnaires have only been studied in North American psychiatric 27 populations and their validity in other settings is unknown.

28 Clinician-rated questionnaires for adolescent populations 29 The only questionnaire identified was CRAFFT (Knight et al., 1999).This is a 30 nine-item measure developed to identify drug misuse for 14-18 year olds in 31 an adolescent medical clinic. A cut-off score of two had a sensitivity of 92% 32 and specificity of 82%. However, this questionnaire has not been validated in 33 a general clinical population administered by clinicians, and its properties in a 34 UK adolescent population, are unknown.

35 Self-report questionnaires for adult populations 36 The shorter variant of the Drug Abuse Screening Test (DAST-10) has been 37 used as a self-report drug misuse screening tool in psychiatric populations 38 (Carey et al., 2003; Maisto et al., 2000). Maisto and colleagues (2000) found that 39 sensitivity ranged from 70–90% and specificity ranged from 67–80%, 40 depending on the cut-off used. It is therefore not of value as an identification 41 tool.

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1 Self-report questionnaires for adolescents 2 The self-report DAST has been adapted for use in adolescent psychiatric 3 populations (Martino et al., 2000) with moderate sensitivity (79%) and 4 specificity (85%). However, with 27 items, it is not likely to feasible for use as 5 an identification tool. 6 7 The Problem-Oriented Screening Instrument for Teenagers (POSIT; Latimer et 8 al., 2004) is a 17-item scale adapted from the 139-item POSIT. It does not have 9 an acceptable level of sensitivity (77%), specificity (60%) or positive predictive 10 value (19%). 11 12 There appear to be no feasible or psychometrically acceptable self-report 13 identification questionnaires.

14 6.2.2 Biological Testing

15 Urinalysis 16 Urinalysis remains the most reliable tool for identifying drug use in a drug 17 using population (Wolff, in press). In the context of identification of drug 18 misuse for at-risk populations in general health and social care populations, 19 the evidence for the sensitivity and specificity of urinalysis is sparse. 20 However, a recent targeted screening study by Tomaszewski and colleagues 21 (2005) in a US emergency department found excellent sensitivity and 22 specificity for opiates (sensitivity = 100%, specificity = 98.7%) and cocaine use 23 (sensitivity = 96.8%, specificity = 100%) but lower sensitivity for cannabis use 24 (sensitivity = 87.5%, specificity = 99.3%) when comparing near-patient urine 25 testing with confirmatory laboratory tests. George and Braithwaite’s (2002) 26 review of point-of-care testing tools (including urine, oral fluid and hair 27 analysis) suggested limited or variable sensitivity in detecting drug use. 28 Similarly, Wolff (in press) argues that such devices may be useful for the 29 detection of short-term usage of drugs but not suitable for widespread routine 30 use.

31 Oral fluid analysis 32 One of the major advantages of oral fluid drug testing is that it can be 33 relatively easily obtained and is less intrusive than urinalysis. These 34 properties enable oral fluid testing to be conducted by personnel with 35 relatively little training and make it less open to adulteration (Wolff, in press). 36 However, oral fluid can only identify very recent consumption of drugs. 37 Detection times for drugs in oral fluid are considerably shorter (5–48 hours) 38 compared with 1.5–4 days in urine (Verstraete, 2004). 39 40 There is sparse evidence for the sensitivity and specificity of oral fluid testing 41 products (Wolff, in press). Gronholm and Lillsunde (2001) found poor 42 sensitivity for detecting benzodiazepines and cannabinoids. In a small study 43 (n = 15), results obtained by law enforcement officers correlated well with

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1 laboratory results for cocaine and amphetamines but were unsatisfactory for 2 detecting heroin and cannabis use (Samyn & Van Haeren, 2000). 3 4 There is a lack of evidence to support the widespread routine use of oral fluid 5 testing for the identification of drug use in at-risk populations in health and 6 social care settings.

7 Hair analysis 8 The testing of human scalp hair for drug use has the potential for detecting 9 drug use over a longer period than urine or oral fluid testing (Wolff, in press). 10 Hair analysis is also potentially less intrusive than urinalysis. 11 12 However, there are a number of difficulties associated with the use of hair 13 analysis. This form of testing is still in a period of development, with 14 sufficient quality-control criteria yet to be established (Wolff, in press). 15 Therefore, hair analysis is associated with the need for a higher level of 16 expertise and consequently the greater costs involved. Once more, there is a 17 lack of evidence to support widespread and routine use of hair analysis for 18 the identification of drug use in at-risk populations.

19 6.2.3 Clinical summary 20 The development of questionnaire tools for identification of drug misuse is in 21 its infancy in comparison to the equivalent methods for detection of alcohol 22 misuse. Although some measures had reasonable sensitivity and specificity 23 the evidence base for this was often drawn only from one or at best two 24 studies. In addition the test with the highest sensitivity and specificity, 25 urinalysis, is not easy to administer as a routine identification instrument and 26 has also low acceptability to service users in non-specialist health care 27 settings. The self-administered or clinician administered measures are easier 28 to administer and probably more acceptable to service users but have weaker 29 sensitivity and specificity and can be time consuming to administer and score. 30 The technologies for oral fluid and hair analysis do not seem to be either well 31 enough developed or available to lend themselves for use in as routine 32 identification tools. Therefore none of the tools identified in this review, 33 applied to either adults or adolescents, can be recommended for routine 34 implementation in any setting on the basis that insufficient validation has 35 been carried out, particularly in the UK context. They confer no significant 36 advantages over the use of sensitive routine clinical enquiry.

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1 6.2.4 Clinical practice recommendations

2 Clinical enquiry

3 6.2.4.1 Healthcare professionals in mental health and criminal 4 justice settings where drug misuse is known to be prevalent should 5 routinely ask service users questions about recent legal and illicit 6 drug use including whether they have used drugs and: 7 • of what type and method of administration 8 • in what quantity and 9 • how frequently.

10 6.2.4.2 In settings such as primary care, general hospitals and 11 accident and emergency departments, enquiry about recent drug use 12 should be considered in presentations in which drug misuse may be 13 implicated, for example in: 14 • acute chest pain in a young person 15 • acute psychosis 16 • mood and sleep disorders.

17 Biological testing

18 6.2.4.3 Healthcare professionals should use biological testing (for 19 example, urine or oral fluid samples) as part of a comprehensive 20 assessment of drug use, but they should not rely on it as the sole 21 method of diagnosis and assessment.

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1 7 Brief interventions and reduction 2 of injection and sexual risk 3 behaviours

4 7.1 Introduction 5 Reducing drug-related harm is a widely cited aim in the treatment of people 6 who misuse drugs (for example, Department of Health, 1999; NTA, 2006a) 7 and is relevant to all chapters in this guideline. This chapter concerns the use 8 of brief interventions to reduce drug-related harm (focused on opiate, 9 stimulants and cannabis) by encouraging abstinence and/or reduction of 10 drug use. Additionally, drug misuse is often associated with increased 11 injection and sexual risk behaviours. This chapter will also consider 12 interventions designed to reduce such risk behaviours.

13 7.2 Brief interventions

14 7.2.1 Introduction 15 Brief interventions have a variety of potential advantages in the treatment of 16 drug misuse, including ease of delivery and less difficulty associated with 17 retaining people who misuse drugs. The provision of such interventions is 18 better developed in the treatment and management of alcohol related 19 problems (SIGN, 2003). It should be noted that a significant proportion of 20 people misusing opiates, stimulants and cannabis also misuse alcohol and this 21 is reflected in the participants in some of the trials described below. These 22 interventions can be conducted in a variety of settings including non-medical 23 settings and can be given opportunistically to people not in formal drug 24 treatment or as an adjunct to formal structured drug treatment (Ashton, 2005).

25 7.2.2 Definitions of interventions 26 Brief interventions are defined here as interventions with a maximum 27 duration of two sessions. The main aim of the intervention is to enhance the 28 possibility of change in terms of abstinence or the reduction of harmful 29 behaviours associated with drug use. The principles of brief interventions 30 include expressing empathy with the service user, not opposing resistance 31 and offering feedback, with a focus on reducing ambivalence. 32 33 In the included studies reviewed below, brief interventions were compared 34 with no treatment/minimal interventions and other active interventions. The 35 minimal interventions mainly consisted of providing a self-help or 36 information booklet on drug misuse. The active interventions included 37 relapse-prevention cognitive behavioural therapy and, for people within 38 formal treatment, standard care. 39

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1 Relapse-prevention cognitive behavioural therapy focuses on helping drug 2 users to develop skills to identify situations or states where they are most 3 vulnerable to drug use, to avoid high-risk situations, and to use a range of 4 cognitive and behavioural strategies to cope more effectively with these 5 situations (Carroll & Onken, 2005). 6 7 Standard care for people in formal drug treatment ranged from methadone 8 maintenance treatment (MMT) to cocaine or opiate detoxification and relapse- 9 prevention cognitive behavioural therapy.

10 7.2.3 Outcomes 11 The primary outcomes assessed were related to abstinence and drug use. 12 Abstinence can be expressed in a variety of ways, but the two main measures 13 examined were point abstinence and duration of abstinence. Measures of 14 abstinence based on urinalysis were preferred but self-report measures were 15 not excluded. Point abstinence refers to evidence for the absence of drug use 16 at a particular point in time (for example, end of treatment or at 12-month 17 follow-up). The main limitation of this measure is that, due to the relapsing 18 nature of drug misuse, it is not necessarily indicative of abstinence over a 19 longer period of time. For example, where a person is abstinent at the end of 20 treatment it does not indicate whether he or she used drugs less during 21 treatment than others who were not abstinent at the end of treatment. 22 Therefore, a measure of the duration of abstinence over a period of time is 23 also important to assess how long a person remains abstinent, and the 24 proportion of days a person is abstinent over a period of time. 25 26 Frequency of illicit drug use is also an important measure because, although 27 abstinence may be a desired goal, reducing the frequency of drug misuse may 28 be a more realistic way of reducing drug-related harm. Drug misuse is usually 29 measured by self-report, usually in terms of the frequency of using particular 30 drugs over a period of time. 31 Current practice 32 Although brief interventions are considered to be an important component of 33 psychosocial treatment in open-access drug services (for example, NTA, 2002, 34 2006a), provision of such interventions varies widely throughout England and 35 Wales. They have been provided in evaluative studies in a range of settings, 36 including in-patient psychiatric settings (Baker et al., 2002), schools (Tait & 37 Hulse, 2003), higher educational settings (Mc Cambridge & Strang, 2003), and 38 general healthcare settings (Miller et al., 2006), as well as in formal drug 39 treatment services (Stotts et al., 2001). However, despite this work, the precise 40 extent of the use and distribution of these interventions is not well 41 understood, but it is reasonable to assume that they are not widely 42 implemented in the UK at the present time. The review considers, therefore, 43 not only the efficacy of brief interventions but also the settings in which they 44 are provided, so as to better understand the likely benefit for people who 45 misuse drugs who are not in formal drug treatment, as well as those who are.

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1 7.2.4 Databases searched and inclusion/exclusion criteria 2 Information about the databases searched and the inclusion/ exclusion 3 criteria used for this section of the guideline are in Table 2. 4 Table 2: Databases searched and inclusion/exclusion criteria for clinical effectiveness of brief interventions Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who misuse opiates, stimulants, cannabis; poly-drug misuse Interventions Brief interventions Outcomes Abstinence: point abstinence, duration of abstinence Illicit drug use

5 7.2.5 Studies considered6 6 The review team conducted a new systematic search for RCTs that assessed 7 the efficacy of brief interventions. 8 9 For the brief intervention review for people not in formal drug treatment or 10 for those seeking treatment , seven trials (BAKER2005; BERNSTEIN2005; 11 COPELAND2001; MARSDEN2006; MCCAMBRIDGE2004; STEPHENS2000; 12 STEPHENS2002) met the guideline eligibility criteria, providing data on 2,701 13 participants. All were published in peer-reviewed journals. In four trials brief 14 interventions were assessed for people who misuse cannabis 15 (COPELAND2001; MCCAMBRIDGE2004; STEPHENS2000; STEPHENS2002), 16 in three trials for people who misuse stimulants (BAKER2005; 17 BERNSTEIN2005; MARSDEN2006) and in one trial for people who misuse 18 opiates (BERNSTEIN2005). 19 20 For the brief intervention review for people within formal drug treatment, 21 four trials (CARROLL2006A; MILLER2003; MITCHESON in press; 22 STOTTS2001) met the guideline eligibility criteria, providing data on 625 23 participants. Of these trials, three were published in peer-reviewed journals 24 and one trial was in press (the full trial report was provided by the author). In 25 all four trials brief interventions were assessed for people who misuse 26 stimulants, in one trial for people who misuse cannabis (CARROLL2006A) 27 and in one trial for people who misuse illicit opiates (MILLER2003). 28 29 For the review comparing brief interventions and CBT (RP), four trials 30 (BAKER2005; COPELAND2001; STEPHENS2000; STEPHENS2002) met the 31 guideline eligibility criteria, providing data on 807 participants. All of these

6 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 were published in peer-reviewed journals. In three trials comparisons 2 between brief interventions and CBT (RP) were examined for people who 3 misuse cannabis (COPELAND2001; STEPHENS2000; STEPHENS2002) and in 4 one trial for people who misuse stimulants (BAKER2005). 5 6 In addition, nine studies were excluded from the analysis. The most common 7 reason for exclusion was not providing required outcomes (further 8 information about both included and excluded studies can be found in 9 Appendix 14).

10 7.2.6 Brief interventions for people who misuse drugs and are not in 11 formal drug treatment or are seeking drug treatment 12 This section assesses brief interventions for people who are not in formal drug 13 treatment (for example, opportunistic interventions for people who are 14 presenting for a physical health problem in primary care) and people who are 15 not in drug treatment but who are seeking treatment for a drug problem. 16 Table 3: Study information table for trials of brief interventions for people who misuse drugs and are not in formal drug treatment or are seeking drug treatment Brief intervention Brief Individual CBT Group CBT (RP) versus self- intervention (RP) versus brief versus brief help/information versus waitlist intervention intervention booklet (seeking drug (seeking drug (seeking drug (not in formal drug treatment) treatment) treatment) treatment) Total no. of 4 RCTs (1 cluster 3 RCTs 3 RCTs 1 RCT trials (total randomised) (N = 970) (N = 602) (N = 205) no. of (N = 1,731) participants) Study ID BAKER2005 COPELAND2001 BAKER2005 STEPHENS2000 BERNSTEIN2005 STEPHENS2000 COPELAND2001 MARSDEN2006 STEPHENS2002 STEPHENS2002 MCCAMBRIDGE 2004 Problem drug Cannabis: Cannabis: Amphetamine: Cannabis (DSM-IV): or diagnosis MCCAMBRIDGE COPELAND2001 BAKER2005 STEPHENS2000 2004 Cannabis (DSM- Cannabis: Cocaine: III-R/IV COPELAND2001 BERNSTEIN2005 dependence): MARSDEN2006 COPELAND2001 Cannabis (DSM-III- Crack cocaine: STEPHENS2000, R/IV dependence): MARSDEN2006 2002 COPELAND2001, STEPHENS2002 Amphetamine: BAKER2005

Heroin: BERNSTEIN2005 Baseline Years regular Years weekly Years regular Years cannabis use: severity: amphetamine use: cannabis use: amphetamine use: 17.35 (5.21); days of mean (SD) 8.98 (6.99); daily 13.9 8.98 (6.99); daily use in past 90 days: level amphetamine (COPELAND level amphetamine 74.64 (18.54) use (OTI): 1.50 2001) use: (OTI): 1.50 (STEPHENS2000) (1.65) (BAKER2005) (1.65) Years cannabis (BAKER2005)

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DAST score: 8.0 use: 17.35 (5.21); (BERNSTEIN2005) days of use in Proportion days of past 90 days: use in past 90 days: 74.64 (18.54) 0.88 (STEPHENS (STEPHENS2002) 2000)

Proportion days of use in past 90 days: 0.88 (STEPHENS 2002) Treatment 1 session 2 sessions CBT: 4 sessions CBT: 14 sessions length (BAKER2005; Brief intervention: 2 COPELAND2001) sessions 9 sessions (STEPHENS2002)

Brief intervention: 1 session (BAKER2005) 2 sessions (COPELAND2001; STEPHENS2000) Length of 3 to 6 months Up to 12 months Up to 12 months 16 months follow-up Age (years) 16 to 38 32 to 36 30 to 36 34

1 2 Table 4: Summary evidence table for trials of brief interventions for people who misuse drugs and are not in formal drug treatment or are seeking drug treatment*

Brief intervention Brief Individual CBT Group CBT (RP) versus versus self- intervention (RP) versus brief brief intervention help/information versus waitlist intervention (seeking drug booklet (seeking drug (seeking drug treatment) (not in formal drug treatment) treatment) treatment) Total no. of 4 RCTs (1 cluster 3 RCTs 3 RCTs 1 RCT trials (total randomised) (N = 970) (N = 602) (N = 205) no. of (N = 1,731) participants) Study ID BAKER2005 COPELAND2001 BAKER2005 STEPHENS2000 BERNSTEIN2005 STEPHENS2000 COPELAND2001 MARSDEN2006 STEPHENS2002 STEPHENS2002 MCCAMBRIDGE 2004 Overall High Moderate Moderate Low quality of evidence Point Stimulants Continuous Cannabis: Abstinence 3- to 6-month duration for Follow-up: RR follow-up: RR 1.34 cannabis: 2.60 (1.45 to 4.66) (1.12 to 1.60), 3 to 4 months: K = 2, N = 462 K = 3, N = 1,665 RR 3.45 (1.94 to 6.10), Follow-up: SMD Heroin K = 3, N = 570 0.24 (-0.13 to Follow-up: RR 1.54 0.51) (1.09 to 2.16), K = 1, Proportion days K = 1, N = 102 N = 1,175 not using

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cannabis: Amphetamine: Heroin and cocaine 3-month follow- RR 0.89 (0.57 to Follow-up: RR = up: SMD -0.42 (- 1.39) 1.45 (1.02 to 2.05), 0.81 to -0.03), K = 1, N = 140 K = 1, N = 1,175 K = 1, N = 105 Drug use Cannabis Cannabis Cannabis Cannabis 3-month follow up 4-month follow- 9-month follow- 12-month follow-up: (adjusted for up: SMD up: SMD -0.43 SMD 0.03 (-0.65 to 0.23) baseline -0.68 (-0.88 to - (-0.58 to -0.17) K = 1, N = 179 differences): 0.49), K = 1, N = 245 B = 11.54 (6.91 to K = 2, N = 432 16.18), p<0.0001 K = 1, N = 200 * RR >1 favours intervention; in comparisons of CBT and brief interventions RR >1 favours CBT; negative SMD values favour intervention; in comparisons of CBT and brief interventions negative SMD values favour CBT; B >1 favours intervention 1 2 Most studies were for people who misuse cannabis or stimulants; brief 3 interventions were associated with greater abstinence and reduced drug use 4 compared to no treatment or minimal control groups for these people (see 5 Table 3 for study information and Table 4 for evidence summary). One trial 6 conducted on opiate users suggests brief interventions may also be effective 7 for this group. 8 9 There were mixed results for comparisons of brief interventions with relapse- 10 prevention cognitive behavioural therapy. For people who misuse cannabis, 11 individual relapse-prevention cognitive behavioural therapy, but not group 12 relapse-prevention cognitive behavioural therapy, appeared to be more 13 effective than brief interventions but it should be noted that the relapse- 14 prevention cognitive behavioural therapy interventions provided in both 15 trials had four times as many sessions as the brief intervention. For people 16 who misuse stimulants (amphetamines), no differences were found between 17 individual relapse-prevention cognitive behavioural therapy and brief 18 interventions.

19 7.2.7 Adjunctive brief interventions versus standard care for people who 20 misuse drugs and are receiving formal drug treatment 21 Brief interventions have also been assessed as an adjunct to formal drug 22 treatment programmes. This section is concerned with whether such an 23 additional intervention for people already engaged in formal treatment 24 improves abstinence and drug use outcomes. 25 26 Table 5: Summary evidence table for trials of brief interventions for people who 27 misuse drugs and are receiving drug treatment* Brief intervention versus Brief intervention Brief intervention Brief intervention standard care for people who versus standard versus standard versus standard misuse drugs and/or alcohol care for people care for people care for people undergoing cocaine undergoing MMT who are primarily detoxification stimulant or heroin misusers Total no. of 1 RCT 1 RCT 1 cluster 1 RCT trials (total (N = 336) (N=52) randomizes trial (N=208)

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no. of (N=29) participants) Study ID CARROLL2006A STOTTS2001 MITCHESON in MILLER2003 press

Problem Alcohol (50%), cannabis (20%), Cocaine (100%) Crack cocaine Cocaine (53%), drug/ stimulants (24%) (100%) heroin (29%) diagnosis

Baseline ASI: Drug: 0.11 (0.12) Mean duration of Crack cocaine use - severity (CARROLL2006A) cocaine use: 10 in last 30 days: years 100%

Treatment 1 session 2 sessions 1 session 1 session length Length of 3 months End of 1 month 12 months follow-up detoxification treatment (10 days) Age (years) 33 35 39 33 Overall Low Moderate Moderate Low quality of evidence Abstinence Abstinent from Abstinence: cocaine after F(1, 55) = 1.12, detoxification: p<.29 RR = 1.44 (1.03 to 2.01)

Drug use Days of primary substance use Days of crack Illicit drug use: at 1-month follow-up: cocaine use in last F (3, 157) = 0.89, SMD = -0.11 (-0.33 to 0.10) 30 days: p<.45 SMD = -0.07 (-0.81 Days of primary substance use to 0.67) of 3-month follow-up: SMD = 0.04 (-0.18 to 0.25)

* RR >1 favours brief intervention; negative SMD values favour brief intervention 1 2 The use of brief interventions as an adjunct to formal drug treatment did not 3 have any important effects on drug use compared to standard care (see Table 4 5). Miller and colleagues (2003) found no statistically significant differences 5 between the brief intervention and standard care groups for days abstinent 6 from illicit drugs or for treatment attendance. This finding was consistent for 7 inpatient and outpatient samples, and for primary cocaine and heroin users. 8 Similarly, Carroll and colleagues (2006a) found no statistically significant 9 differences in days using primary substances. 10 11 A cluster randomised trial in the UK also found no statistically significant 12 differences between the brief intervention and control groups on the primary 13 outcome of crack-cocaine use. However, the brief intervention group reported 14 a statistically significant reduction in heroin use compared to control 15 (Mitcheson et al., in press). 16

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1 In contrast, Stotts and colleagues (2001) found that an adjunctive brief 2 intervention reduced cocaine use during cocaine detoxification. However, the 3 intervention appeared to be more effective for those with lower motivation at 4 baseline. This offers a possible explanation for why the effect of the brief 5 intervention was more pronounced in this study than the others. Participants 6 in other studies receiving formal drug treatment may have already felt 7 motivated to change their drug use and therefore did not require an 8 additional motivational intervention.

9 7.2.8 Clinical summary 10 The majority of meta-analyses of brief interventions do not distinguish the 11 context in which the intervention is conducted (for example, Burke, 2003). The 12 results of the current systematic review, discussed above, suggest this is 13 important. People who misuse cannabis or stimulants, and not in formal drug 14 treatment, appear to respond well to brief interventions both in terms of 15 increased abstinence levels and reduced drug use. There is some evidence to 16 suggest people who misuse opiates who are not in formal drug treatment may 17 also benefit from such interventions. 18 19 In contrast, for people already receiving formal drug treatment, an additional 20 brief intervention did not appear to have much effect on abstinence or drug 21 use in most studies. Although one study did find evidence of benefit, this was 22 mainly accounted for by participants with lower motivation at baseline. The 23 majority of studies were for people who misuse stimulants, although similar 24 findings were also found for people who misuse cannabis or heroin. Ashton 25 (2005), in a review of brief interventions, suggested that such interventions are 26 effective for people who are ambivalent about change but ineffective for 27 people who are motivated to change and already receiving treatment. 28 29 Results were mixed for comparisons of brief interventions with longer 30 interventions for people who misuse cannabis or amphetamines. All the 31 studies were for people seeking drug treatment. Individual relapse- 32 prevention cognitive behavioural therapy, lasting between four and nine 33 sessions, was associated with greater levels of abstinence and reductions in 34 drug use for people who misuse cannabis, although interventions of such 35 duration are effectively brief treatments. However, no differences were found 36 for group relapse-prevention cognitive behavioural therapy for cannabis 37 misuse or individual relapse-prevention cognitive behavioural therapy for 38 amphetamine misuse. Further research is required to assess the efficacy of 39 brief interventions in comparison with individual and group relapse- 40 prevention cognitive behavioural therapy, other interventions, and with 41 people who misuse drugs other than cannabis.

42 7.2.9 Clinical practice recommendations

43 7.2.9.1 For people in limited contact with services (for example, 44 attendance at a needle and syringe exchange) and if concerns about

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1 drug misuse are identified by the service user or healthcare 2 professional, opportunistic brief interventions should be offered. 3 These interventions should: 4 • be of a maximum duration of two sessions (normally ranging 5 between 10 and 45 minutes) 6 • offer appropriate information and feedback in an empathic 7 manner.

8 7.2.9.2 For people not in contact with drug misuse services and if 9 concerns about drug misuse are identified by the service user or 10 healthcare professional, opportunistic brief interventions should be 11 offered. These interventions should: 12 • be of a maximum duration of two sessions (normally ranging 13 between 10 and 45 minutes) 14 • offer appropriate information and feedback in an empathic 15 manner.

16 7.3 Psychosocial interventions to improve compliance with physical 17 healthcare

18 7.3.1 Introduction 19 Psychosocial interventions to improve compliance with physical healthcare 20 for problems associated with the misuse of drugs have been developed which 21 potentially could improve the prevention (for example, hepatitis B 22 vaccinations), identification (for example, HIV or hepatitis C tests) and 23 treatment (for example, anti-retrovirals for people with hepatitis C) of the 24 physical problems in people who misuse drugs. The psychosocial 25 interventions that have received the most research attention in this area are 26 contingency management and outreach. 27 28 Contingency management provides a system of incentives and disincentives 29 (although almost all studies are concerned with provision of incentives) 30 designed to make continual drug use less attractive and abstinence more 31 attractive (Griffith et al., 2000). The two major methods of providing 32 incentives in the context of increasing compliance with physical healthcare 33 are: 34 35 Voucher-based reinforcement: the individual receives vouchers with various 36 monetary values for engaging in a particular behaviour (for example, 37 returning for a TB skin test or hepatitis B vaccination). Once earned, 38 vouchers are exchanged for goods or services such as food or shopping. 39 40 Cash: the individual receives cash for engaging in a particular behaviour. 41 42 Outreach involves targeting high risk and local priority groups. The four 43 generally agreed aims of outreach work are to: identify and contact hidden

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1 populations, refer members of these populations to existing care services, 2 initiate activities aimed at prevention and at demand reduction, and promote 3 safer sex and safer drug use (European Monitoring Centre for Drugs and 4 Drug Addiction, 1999). 5 Current practice 6 There are a number of physical health problems commonly associated with 7 drug misuse. For example, more than two in five injecting drug users in the 8 UK have been infected with hepatitis C. In England and Wales, hepatitis C 9 transmission among injecting drug users is high, with one in six of those who 10 had started to inject since the beginning of 2002 having become infected 11 (Health Protection Agency, 2005). 12 13 Uptake of testing for hepatitis C among injecting drug users in contact with 14 drug services has increased in recent years as offering tests has become part of 15 routine management (NTA, 2006). It is estimated, however, that around half 16 of those injecting drug users with hepatitis C in contact with these services 17 still remain unaware of their infection (Health Protection Agency, 2005). It is 18 also likely that there are substantial numbers of current and former injecting 19 drug users who are not in contact with services who will be unaware that they 20 have hepatitis C. A recent study found that case finding for hepatitis C in 21 injecting drug users is cost effective (Castelnuovo et al., 2006). In addition, 22 NICE has recommended the use of pegylated interferon and ribavirin for the 23 treatment of hepatitis C (NICE, 2004, 2006).

24 7.3.2 Databases searched and inclusion/exclusion criteria 25 Information about the databases searched and the inclusion/ exclusion 26 criteria used for this section of the guideline are in Table 6. 27 Table 6: Databases searched and inclusion/exclusion criteria for clinical effectiveness of interventions to improve compliance with physical healthcare Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Observational studies Patient population People who misuse opiates, stimulants, cannabis; poly-drug misuse Interventions CM, outreach Outcomes compliance with physical health/harm-reduction interventions

28 7.3.3 Studies considered7 29 For the search on psychosocial interventions to reduce injection and sexual 30 risk behaviour (see Section 7.4), a study on increasing compliance with

7 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 physical healthcare was identified (MALOTTE2001). The review team then 2 conducted an additional systematic search for RCTs and observational studies 3 that assessed the efficacy of psychosocial interventions to increase compliance 4 with physical healthcare. 5 6 For the efficacy review of contingency management, five RCTs 7 (MALOTTE1998; MALOTTE1999; MALOTTE2001; SEAL2003; 8 SORENSEN2006) met the eligibility criteria, providing data on 2,412 9 participants. 10 11 Two trials were for reinforcing return for a TB test (MALOTTE1998; 12 MALOTTE1999), one trial to reinforce compliance with prophylactic TB 13 medication (MALOTTE2001), one trial to reinforce hepatitis B vaccination 14 (SEAL2003) and one trial for compliance with HIV anti-retroviral medication 15 (SORENSEN2006). 16 17 For the review of implementing contingency management, a further five 18 studies met the eligibility criteria (BRASSARD2004; CHAISSON1998; 19 FITZGERALD1999; LORVICK1999; PERLMAN2003), providing data on 2,417 20 participants. All studies were published in peer-reviewed journals. 21 22 Three studies were for reinforcing return for a TB skin test (BRASSARD2004; 23 CHAISSON1998; FITZGERALD1999), one study was for a chest x-ray to 24 confirm TB (PERLMAN2003), and one study (LORVICK1999) was for 25 returning a TB skin test followed by prophylactic medication (further 26 information about both included and excluded studies can be found in 27 Appendix 14).

28 7.3.4 Contingency management to improve physical healthcare Table 7: Summary evidence table for contingency management to improve physical healthcare* One-off CM versus standard care for CM versus standard outreach for compliance with TB skin tests and compliance with prophylactic TB hepatitis B vaccination medication, HIV anti-retroviral medication and hepatitis B vaccination Total no. of 3 RCTs 3 RCTs trials (total no. (N = 2,183) (N = 325) of participants) Study ID MALOTTE1998 MALOTTE2001 MALOTTE1999 SEAL2003 SEAL2003 SORENSEN2006 Problem drug Injection drug use: all Injection drug use: all or diagnosis Crack cocaine: MALOTTE1998, 1999 Crack cocaine: MALOTTE2001

HIV positive: SORENSEN2006 Baseline Drug use in past 30 days: injection Injection in past 30 days: heroin – 74%, severity: mean only – 24%, crack only – 41%, crack methamphetamine – 16%, speedball (SD) and injection – 23% (MALOTTE1998) (heroin with methamphetamine) – 51% (SEAL2003)

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Drug use in past 90 days: injection only – 11%, crack cocaine 77%, crack and injection – 12% (MALOTTE1999)

Injection in past 30 days: heroin – 74%, methamphetamine – 16%, speedball (heroin with methamphetamine) – 51% (SEAL2003) Nature of One-off cash payment or voucher, $5– Cash or vouchers incentive 20 in value

Treatment Single reward for adherence to single 6 months length session Length of Up to 5 months Not followed up follow-up Age (years) 18 to 43 23 to 49 Overall quality High High of evidence Adherence to Returned for skin test or vaccination: Completed full course of vaccination harm-reduction RR 2.00 (1.48 to 2.72) or prophylaxis: RR 6.38 (1.00 to 40.54), intervention K = 3, N = 828 K = 2, N = 206

Proportion medication taken on time: During treatment: SMD -1.07 (-1.59 to -0.55), K = 1, N = 66

During 1-month follow-up: SMD -0.48 (-0.97 to 0.01) K = 1, N = 66 *RR>1 favours contingency management, negative SMD values favour contingency management 1 Table 6 shows that contingency management, with either cash or vouchers, is 2 more effective than standard care or outreach for increasing compliance with 3 a range of physical healthcare interventions, including returning for TB skin 4 tests and hepatitis B vaccinations, and compliance with medication (TB 5 prophylaxis and HIV anti-retrovirals). 6 Implementation studies of contingency management to engage people in 7 harm-reduction treatment 8 Three comparative studies with historical controls (Chaisson et al., 1998; 9 FitzGerald et al., 1999; Perlman et al., 2003) and two case series (Brassard et al., 10 2004; Lorvick et al., 1999) have documented the implementation of 11 contingency management to enhance compliance with TB screening and 12 prophylaxis in a variety of settings where injection drug use is prevalent. 13 14 Using a prospective comparative design, Chaisson and colleagues (1996) 15 analysed return rates for purified protein derivative tuberculin skin test 16 readings among 666 HIV-infected participants (49% of whom injected drugs) 17 in an urban HIV clinic in Baltimore, USA. Participants had a purified protein 18 derivative skin test planted and were offered respectively over three phases of 19 the study: no intervention (n = 272); a fast-food voucher incentive, roughly 20 US$4 in value, on return for purified protein derivative reading within 3 days 21 (n = 229); or a brief educational message from the test nurse emphasising the 22 importance of returning for a reading, in addition to a fast-food voucher upon

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1 return (n = 158). Return rates for both voucher incentive (RR = 1.38; 95% CI: 2 1.11 to 1.70) and voucher incentive plus education (RR = 1.74; 95% CI: 1.42 to 3 2.14) groups were higher than for the control group. 4 5 Similar findings were reported by FitzGerald and colleagues (1999), who 6 studied 1,107 service users of a community-based needle and syringe 7 exchange service in Vancouver, Canada. In the first phase of the study, 558 8 participants were offered no incentives, whereas the 549 participants in the 9 second phase were offered CA$5 cash on return for a purified protein 10 derivative reading. The return rate was again significantly higher for the 11 incentive group than for the control group (RR = 1.77; 95% CI: 1.59 to 1.97). 12 Another Canadian study, a case series (Brassard et al., 2004), also reported a 13 very high return rate (94% of 262 injecting participants) for purified protein 14 derivative readings, where a cash incentive of CA$10 was offered contingent 15 on return. 16 17 In a comparative study by Perlman and colleagues (2003), 177 service users of 18 an inner-city needle and syringe exchange service in New York with a 19 positive purified protein derivative reading were referred off site for a 20 confirmatory chest x-ray. Consecutive cohorts of participants were offered, 21 respectively, standard reimbursement for transportation (n = 119) and an 22 additional US$25 cash incentive on adherence within 7 days to the chest x-ray 23 referral (n = 58). The incentive group were more likely to adhere to the chest 24 x-ray referral than the control group (RR = 2.69; 95% CI: 2.06 to 3.52). 25 26 One case series (Lorvick et al., 1999) followed 205 street-recruited injection 27 drug users in the San Francisco Bay Area, USA, from initial purified protein 28 derivative skin test through to isoniazid (anti-tuberculosis) prophylaxis 29 (where indicated). Cash incentives of US$10 were offered at each point of 30 initial contact (skin-test reading, medical evaluation and prophylaxis 31 enrolment appointment) as well as subsequent contact for observed 32 medication, which was administered twice weekly over a 6-month course. 33 Adherence was high throughout, for example with 87% of 205 participants 34 having returned for the purified protein derivative reading, and 89% of the 27 35 participants requiring prophylaxis having completed the full course of 36 treatment. 37 38 In summary, non-RCTs of the implementation of contingency management in 39 routine care provide further evidence to support the effectiveness of monetary 40 incentives in encouraging people who misuse drugs to comply with 41 preventive interventions for TB. These interventions were implemented in 42 different localities across the USA as well as Canada with apparently 43 consistent effectiveness, which should be noted in considering whether 44 similar interventions may be successfully implemented in the UK. 45 Participants in the above studies were recruited from a number of different 46 settings with a high rate of injecting drug use, including needle and syringe

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1 exchange programmes and HIV clinics. It should also be noted that, in all the 2 studies considered, the one-off incentives were all modest in value, ranging 3 from US$4–25 (approximately £2–12.50).

4 7.3.5 Clinical summary 5 The main interventions assessed in this section were contingency 6 management for one-off practices (for example, TB skin test readings and 7 hepatitis B vaccinations) and compliance with physical health medication (TB 8 prophylaxis, HIV anti-retrovirals). Contingency management interventions 9 appear to be considerably more successful than standard care or outreach in 10 increasing the proportion of participants presenting for TB tests, vaccinations 11 for hepatitis B and compliance with TB and HIV medications. Although TB is 12 possibly not as prevalent among drug users in the UK in comparison with the 13 US, it is likely these findings can be generalised to physical health problems 14 more common in the UK (such as hepatitis C). Although there are no UK 15 studies assessing contingency management in this context, the findings are 16 consistent across a number of locations in the US and Canada, and also in a 17 variety of naturalistic studies, increasing the likelihood that these effects are 18 generalisable to other contexts. 19 20 A number of these studies (for example, Fitzgerald et al, 1999; Bassard et al, 21 2004) have looked at the effectiveness of contingency management in 22 improving compliance with TB screening in injecting drug users. Both 23 reported on the impact of small financial incentives for completion of the 24 screening programme and Fitzgerald and colleagues (1999) described 25 increased compliance (43% v.78%) following the introduction of contingency 26 management.

27 7.3.6 Clinical practice recommendation

28 7.3.6.1 For all people at risk of physical health problems (including 29 transmittable diseases) resulting from their drug misuse, the use of 30 modest material incentives (for example, shopping vouchers, up to 31 £10 in value) should be considered to encourage specified harm- 32 reduction objectives. Incentives should be delivered on a one-off basis 33 or over a limited duration, contingent on compliance with or 34 completion of each intervention, in particular: 35 • hepatitis B/C and HIV testing 36 • hepatitis B immunisation schedule 37 • TB test.

38 7.4 Psychosocial interventions to reduce injecting and sexual risk 39 behaviours

40 7.4.1 Introduction 41 It is widely accepted that injecting drug users are at greater risk of 42 developing blood-borne viruses than the general population and that many

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1 engage in injecting and sexual risk behaviours. A recent prospective cohort 2 study of new injecting drug users in London found high levels of injecting 3 risk behaviour (Judd et al., 2005). A total of 24% reported having injected in 4 the last 4 weeks with needles and syringes used by someone else and 53% 5 having shared injecting paraphernalia. The baseline prevalence of antibodies 6 to hepatitis C virus was 44% and of antibodies to HIV 4%. It would appear 7 that injecting drug users in London have a higher incidence of hepatitis C 8 virus than those in many cities worldwide, and an incidence of HIV 9 comparable to that among men who have sex with men attending clinics for 10 sexually transmitted infections in London (Judd et al., 2005). Therefore, 11 reducing the risk of blood-borne viruses among injecting drug users is an 12 important issue in the UK. It has also been noted that people who misuse 13 crack or cocaine have also exhibited high levels of sexual risk behaviour (for 14 example, Malow et al., 1994). Therefore, it is important not to exclude other 15 groups of people who misuse drugs from such interventions. 16 17 One of the central public health interventions to reduce injection drug use in 18 the UK has been through the establishment of needle and syringe exchange 19 programmes. A number of studies have assessed the efficacy of needle and 20 syringe exchange programmes. The results have been summarised in several 21 recent systematic reviews (for example, Gibson et al., 2001; Ksobiech, 2003; 22 Wodak & Coney, 2006). The main aim of these studies was to assess the 23 efficacy of needle and syringe exchange programmes on a range of outcomes, 24 including reducing injection risk behaviour and HIV seroconversions. While 25 the efficacy of needle and syringe exchange programmes per se is beyond the 26 scope of this guideline, the additional psychosocial elements of these 27 programmes are assessed below. 28 Current practice 29 One of the primary methods of reducing injection risk behaviour in the UK is 30 through the use of needle and syringe exchange programmes. In 1998, there 31 were 2,000 needle and syringe exchange outlets in the UK distributing over 25 32 million syringes annually (Hunter et al., 2000). 33 34 The psychosocial components of needle and syringe exchange programmes 35 can be divided into two main aspects: methods of distributing sterile needles, 36 and psychosocial interventions designed specifically to reduce sexual and 37 injection risk behaviours above and beyond providing sterile needles. 38 39 The distribution of needles can vary widely in the extent of psychosocial 40 contact involved. Some needle and syringe exchange programmes provide 41 sterile needles by dispensing machine and therefore potentially involve very 42 little psychosocial contact. Conversely, other programmes distribute sterile 43 needles through counsellors and therefore may involve more opportunities 44 for interaction with the person who misuses drugs. 45

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1 Needle and syringe exchange programmes often include additional 2 psychosocial interventions such as education about blood-borne viruses to 3 reduce injection and sexual risk behaviours (for example, Des Jarlais, 1996; 4 Huo, 2006).

5 7.4.2 Definitions of interventions 6 The most common intervention designed to reduce injection and sexual risk 7 behaviour is psychoeducation. 8 9 Psychoeducation, as described here, is a programme designed for individuals 10 or groups of people who misuse drugs that combines education about blood- 11 borne viruses (such as HIV or hepatitis C) with skills training to improve 12 communication skills, assertiveness, and safe sexual and injection risk 13 behaviour. It also provides people who misuse drugs with an opportunity to 14 ask questions and receive relevant feedback. These interventions are typically 15 provided over 4 to 6 sessions in a variety of settings such as methadone 16 maintenance clinics, needle and syringe exchanges, and outreach 17 programmes.

18 7.4.3 Outcomes 19 HIV seroconversion refers to the production of specific antibodies to antigens 20 present in the body resulting in a change of a serologic test from negative to 21 positive, indicating the development of antibodies in response to infection 22 (Macpherson, 2002). 23 24 Injection risk behaviour includes the frequency of injection drug use, sharing 25 needles and reusing needles (Darke et al., 1991). 26 27 Sexual risk behaviour refers to unsafe sexual practices, including not using 28 condoms, either with a regular or casual partner, having multiple sexual 29 partners and anal sex (Darke et al., 1991).

30 7.4.4 Databases searched and inclusion/exclusion criteria 31 Information about the databases searched and the inclusion/ exclusion 32 criteria used for this section of the guideline are in Table 8. 33 Table 8: Databases searched and inclusion/exclusion criteria for clinical effectiveness of interventions to reduce HIV risk behaviours Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who misuse opiates, stimulants, cannabis; poly-drug misuse Interventions HIV psychoeducation, CM, psychosocial components of NSE programmes, CBT(RP), CBT (S), IPT, BCT, family-based interventions Outcomes Reduced risk behaviours associated with HIV and other blood-borne viruses, HIV seroconversion

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1 7.4.5 Studies considered8 2 The review team conducted a new systematic search for RCTs that assessed 3 the efficacy of psychosocial interventions to reduce sexual and injection risk 4 behaviour. 5 6 For the review of psychoeducation, 15 trials (AVANTS2004; BAKER1993; 7 COLON1993; ELDRIDGE1997; EPSTEIN2003; HARRIS1998, 8 KOTRANSKI1998; MALOW1994; O′NEILL1996; SIEGAL1995, 9 SCHILLING1991; SORENSEN1994: study 1; SORENSEN1994: study 2; 10 STERK2003; WECSHBERG2004) met the eligibility criteria, providing data on 11 4,651 participants. All trials were published in peer-reviewed journals. 12 13 For the review of standard education, five trials (BAKER1993; BAKER1994; 14 GIBSON1999: study 1; GIBSON1999: study 2; TUCKER2004A) met the 15 eligibility criteria, providing data on 735 participants. All trials were 16 published in peer-reviewed journals. 17 18 For the review of psychosocial interventions within needle and syringe 19 exchange programmes, one RCT (KIDORF2005) met the eligibility criteria 20 providing data on 302 participants. This trial was published in a peer- 21 reviewed journal. 22 23 An additional search for observational studies on psychosocial interventions 24 within needle and syringe exchange programmes was undertaken, since only 25 one RCT on psychosocial interventions was identified from the original search 26 and no trials that assessed directly the efficacy of machine-dispensing needle 27 and syringe exchange programmes in comparison with counsellor-distributed 28 programmes. 29 30 For the review of psychosocial interventions within needle and syringe 31 exchanges, a narrative review (DOLAN2003) and two descriptive studies 32 (JACOB2000; NELLES1999) were identified. 33 34 In addition, 18 studies were excluded from the analysis. The most common 35 reason for exclusion was not being an RCT (further information about both 36 included and excluded studies can be found in Appendix 14).

37 7.4.6 Skills-based HIV psychoeducation versus standard HIV education Table 9: Study information table for trials of HIV education for people who misuse drugs Psychoeducation Psychoeducation Standard education Psychoeducation versus standard versus self-help versus self-help versus standard HIV education booklet booklet education, for at-

8 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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risk subgroup Total no. of 12 RCTs 4 RCTs 5 RCTs 4 RCTs trials (total (N = 4,412) (N = 334) (N = 735) (N = 2,816) no. of participants) Study ID AVANTS2004 BAKER1993 BAKER1993 COLON1993 BAKER1993 SCHILLING1991 BAKER1994 KOTRANSKI1998 COLON1993 SORENSEN1994: GIBSON1999: MALOW1994 ELDRIDGE1997 study 1 study 1 SIEGAL1995 EPSTEIN2003 SORENSEN1994: GIBSON1999: HARRIS1998 study 2 study 2 KOTRANSKI1998 TUCKER2004A MALOW1994 O′NEILL1996 SIEGAL1995 STERK2003 WECSHBERG2004 Problem drug Injection drug use: Injection drug use: Injection drug use: Injection drug use: or diagnosis BAKER1993 BAKER1993 all COLON1993, COLON1993 KOTRANSKI1998, KOTRANSKI1998 Opiates (DSM-III- Heroin: SIEGAL1995 O′NEILL1996 R/IV dependence, TUCKER2004A SIEGAL1995 MMT or Cocaine (DSM-III- STERK2003 undergoing Opiates (entering R/IV dependence): detoxification): detoxification): MALOW1994 Crack: SCHILLING1991, GIBSON1999: WECSHBERG2004 SORENSEN1994: studies 1 & 2 HIV positive: studies 1 & 2 KOTRANSKI1998 Cocaine (DSM-III- HIV positive: (5%), SIEGAL1995 R/IV dependence): HIV positive: BAKER1993 (6%) (1.5%) AVANTS2004 BAKER1993 (6%) MALOW1994 Hepatitis C: TUCKER2004A Opiates (DSM-III- (64%) R/IV dependence or MMT): AVANTS2004 HARRIS1998 O′NEILL1996

Court-ordered inpatient treatment: ELDRIDGE1997

HIV positive: BAKER1993 (6%), ELDRIDGE1997 (2.9%), KOTRANSKI1998 (5%), SIEGAL1995 (1.5%) Treatment 3 to 16 sessions 2 to 6 sessions 1 session 3 to 4 sessions length 1 2 Table 10: Summary evidence table for trials of HIV education for people who 3 misuse drugs* Psychoeducation Psychoeducation Standard education Psychoeducation versus standard versus self-help versus self-help versus standard HIV education booklet booklet education, for at- risk subgroup

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Total no. of 12 RCTs 4 RCTs 5 RCTs 4 RCTs trials (total (N = 4,412) (N = 334) (N = 735) (N = 2,816) no. of participants) Study ID AVANTS2004 BAKER1993 BAKER1993 COLON1993 BAKER1993 SCHILLING1991 BAKER1994 KOTRANSKI1998 COLON1993 SORENSEN1994: GIBSON1999: MALOW1994 ELDRIDGE1997 study 1 study 1 SIEGAL1995 EPSTEIN2003 SORENSEN1994: GIBSON1999: HARRIS1998 study 2 study 2 KOTRANSKI1998 TUCKER2004 MALOW1994 O΄NEILL1996 SIEGAL1995 STERK2003 WECSHBERG2004 Overall Moderate Moderate Moderate Moderate quality of evidence Injection risk Engaging in risk Various measures: Engaging in risk Unsafe at baseline, behaviours behaviours: RR 0.95 SMD -0.02 (-0.33 to behaviours: safer at endpoint: (0.73 to 1.23) 0.29) 3-month follow-up: RR 1.09 (0.98 to K = 3, N = 841 K = 3, N = 166 RR 0.89 (0.53 to 1.21) 1.50) K = 3, N = 1261 Various measures: K = 2, N = 296 SMD -0.21 (-0.42 to 0.00) Various measures: K = 3, N = 353 1- to 3-month follow-up: SMD - 0.04 (-0.29 to 0.21) K = 2, N = 243

4- to 6-month follow-up: SMD - 0.17 (-0.50 to 0.16) K = 2, N = 140 Sexual risk Engaging in risk Engaging in risk Engaging in risk Unsafe at baseline, behaviours behaviours: behaviours: RR 0.58 behaviours: safer at endpoint: Endpoint: RR 0.91 (0.35 to 0.98) 3-month follow-up: RR 1.56 (1.25 to (0.73 to 1.12) K = 1, N = 92 RR 0.94 (0.74 to 1.95), K = 5, N = 1,123 1.21) K = 3, N = 1,195 Various measures: K = 2, N = 296 6-month follow-up: SMD -0.32 (-0.57 to RR 0.94 (0.82 to -0.07) Various measures: 1.07) K = 4, N = 240 1- to 3-month K = 2, N = 460 follow-up: SMD -0.09 (-0.34 to 0.17) Various measures: K = 2, N = 243 SMD -0.30 (-0.47 to -0.13), favours 6-month follow-up: psychoeducation SMD 0.06 (-0.27 to K = 5, N = 541 0.39) K = 2, N = 140 * RR>1 favours intervention, negative SMD values favour intervention

1 7.4.7 Clinical summary 2 A number of RCTs have been conducted to assess the efficacy of HIV 3 psychoeducation for reducing injection and sexual risk behaviours. The 4 review also drew on a number of observational studies. From this review, it 5 appears that psychoeducational programmes have little or no effect on

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1 injection risk behaviour and a limited and inconsistent impact on the 2 reduction of sexual risk behaviour in people who misuse drugs. Interpretation 3 of the research is made difficult by the lack of data on HIV seroconversion 4 rates.

5 7.4.8 Clinical practice recommendations

6 7.4.8.1 Healthcare professionals should provide during routine 7 contacts and opportunistically (for example at a needle and syringe 8 exchange) information and advice to all people who misuse drugs 9 about reducing their exposure to the transmission of blood-borne 10 viruses including the reduction of sexual and injection risk 11 behaviours, and if appropriate offer testing for such viruses.

12 7.4.8.2 Healthcare professionals should not routinely provide 13 separate group-based psychoeducational interventions for people 14 who misuse drugs designed specifically to provide information and 15 advice about reducing exposure to blood-borne viruses, including the 16 reduction of sexual and injection risk behaviours.

17 7.4.9 Psychosocial components of needle and syringe exchange 18 programmes 19 Modes of distribution 20 There are no studies that directly compare machine-distributed needle 21 exchanges with counsellor-distributed needle exchanges. Some brief indirect 22 comparisons can be made, although conclusions are difficult to draw from 23 such studies. Jacob and Stover (2000) assessed the establishment of two needle 24 and syringe exchange programmes (one in a men’s prison and another in a 25 women’s prison) in Germany over a 2-year period. Both prisons were given 26 the option of distributing needles through slot machines or by counsellors; the 27 men’s prison opted for counsellors distributing needles whereas the women’s 28 prison opted for slot machines. Each prison offered similar levels of 29 psychosocial support. 30 31 Although this allows some comparisons to be made between the two modes 32 of distribution, the study was predominantly descriptive. The general 33 conclusions were that staff and prisoners evaluated the machine distribution 34 needle and syringe exchange programme more positively than the counsellor 35 distribution programme. Prisoners appeared to prefer the anonymity of 36 machine distribution of needles. 37 38 Nelles and colleagues (1998) also described the establishment of a machine- 39 distributed needle and syringe exchange programme in a women’s prison in 40 Switzerland. There were reported reductions in sharing of needles and 41 injection drug use. 42

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1 In addition, Dolan (2003) reviewed a study on counsellor-distributed needle 2 and syringe exchange programmes in two Spanish prisons. Once more, there 3 was evidence of the effectiveness of the programme, with reduced levels of 4 blood-borne viruses. 5 Psychosocial interventions conducted in needle and syringe exchange 6 programmes 7 Assessment of the efficacy of additional psychosocial interventions within 8 needle and syringe exchange programmes requires comparison with a 9 minimal control or no treatment group. Only one RCT was found that 10 compared psychosocial interventions with a control in needle and syringe 11 exchange programmes. Kidorf and colleagues (2005) compared the use of a 12 one-session brief intervention with standard referral and an attentional 13 control. No statistically significant differences were found between the brief 14 intervention group and the two control groups.

15 7.4.10 Clinical summary 16 Only one trial was found that assessed an additional psychosocial 17 intervention compared to a standard needle and syringe exchange 18 programme. No differences were found in terms of reduction of risk 19 behaviour. Further research is required to assess the efficacy of additional 20 interventions within these programmes. 21 22 Most studies evaluating needle and syringe exchange programmes failed to 23 provide enough detail on the mode of distribution. Studies that provided 24 these details were primarily descriptive and did not seek to compare different 25 methods of distributing needles. At present, it is not possible to conclude 26 whether machine or counsellor distribution of syringes or needles are 27 associated with better outcomes. 28

29 7.4.11 Research recommendation - psychosocial interventions within 30 needle and syringe exchange programmes

31 7.4.11.1 For people who use injection drugs, do needle and syringe 32 exchange programmes with greater psychosocial content (including 33 staff distribution of syringes and needles and/or provision of 34 psychoeducation on reducing blood-borne virus risk) compared with 35 those with minimal psychosocial content (including machine 36 dispensing of syringes and needles and minimal or no information on 37 reducing blood-borne virus risk) reduce injection and sexual risk 38 behaviours and seroprevalence blood-borne virus rates associated 39 with drug use? 40 41 Why this is important 42

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1 There is extensive literature assessing whether needle and syringe exchange 2 programmes reduce injection and sexual risk behaviour and HIV 3 seroprevalence rates. However, there is very little research that seeks to 4 distinguish the impact of the provision of sterile needles from the 5 psychosocial interventions often offered in such programmes. Psychosocial 6 contact and interventions in needle and syringe exchange programmes 7 require a great deal of resources, therefore it is important to assess whether 8 these additional psychosocial elements are clinically and cost-effective. 9

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1 8 Psychological interventions

2 8.1 Introduction 3 Psychological approaches to the treatment of drug misuse have been the 4 subject of much research and debate over the years (Wanigaratne et al., 2005). 5 Such approaches vary depending on the theoretical model underpinning 6 them but are broadly based on the use of the interaction between therapist 7 and service user to elicit changes in the service user’s behaviour (for example, 8 drug use), as well as other related factors including cognition and emotion. 9 This chapter is concerned with structured psychological approaches used to 10 help people with drug problems in their efforts to change drug-using 11 behaviour. The approaches reviewed here contrast with those reviewed 12 within the brief interventions chapter in that they are longer in duration, and 13 usually are part of a treatment plan within specialist services. 14 15 Over recent years, there has been an increase in the development and 16 evaluation of psychological interventions in drug misuse treatment including: 17 cognitive behavioural therapy, motivational approaches, contingency 18 management treatments and family-based interventions. Psychological 19 interventions within this field have been used either as stand-alone treatments 20 or in combination with pharmacological interventions. In order to reflect this, 21 the chapter has been divided into four sections: psychological interventions 22 alone that are used without pharmacological interventions, psychological 23 interventions used in combination with opiate agonist maintenance treatment, 24 psychological interventions used in combination with naltrexone maintenance 25 treatment and, finally, the application of psychological treatments within 26 broader packages of care (for example, day care and case management). In 27 addition, the available research on self-help approaches is also reviewed. 28 29 Psychological treatments can also be used to help people who misuse drugs 30 address coexisting disorders such as anxiety and depression. These 31 approaches are not covered within this review and the reader is referred to 32 the separate NICE guidelines that address psychological interventions for 33 specific mental health problems9. Healthcare professionals should note that, 34 although the presence of substance misuse problems may impact, for 35 example, on the duration of a formal psychological treatment, there is no 36 evidence supporting the view that psychological treatments for common 37 mental disorders are ineffective for people with substance misuse disorders 38 (see for example, Woody et al., 1985). The position with regard to severe 39 mental disorders such as schizophrenia is different and current evidence 40 suggests that specifically designed interventions are required for this group 41 (Bellack et al, 2006).

9 www.nice.org.uk

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1 2 Clinical practice recommendation

3 8.1.1.1 Cognitive behavioural therapy should be considered for the 4 treatment of comorbid disorders such as anxiety and depression (in 5 line with existing NICE guidance for the treatment of these disorders) 6 for people who misuse cannabis, stimulants and opiates. 7 8 Current practice 9 Despite the recent increase in research on psychological treatments, current 10 UK practice is not underpinned by a strong evidence base and there is wide 11 variation in the uptake and implementation of psychological approaches to 12 treatment across services. A number of factors may contribute to this 13 situation. First, the emphasis in many community-based opiate treatment 14 services is based on pharmacological management and supportive case 15 coordination, with practice tending to be influenced more by the background 16 and training of those delivering treatment within services than what research 17 has shown to be effective. Second, a considerable amount of the evidence is 18 extrapolated from other disorders (predominantly alcohol misuse) or other 19 healthcare systems, for example the United States or Australia, and inevitably 20 this raises questions about the applicability of the evidence to UK drug 21 misuse services. Thirdly, there has been weak dissemination of the evidence 22 base concerning psychological interventions until recently (Wanigaratne et al., 23 2005). Fourthly, the limited availability of appropriately trained therapists 24 also contributes significantly to variable access to such services in the UK 25 (Lovell et al; 2003). 26 27 Standard care in the UK typically consists of keyworking (Roxburgh, 2006) 28 which, as a matter of good practice, involves the building of a therapeutic 29 relationship with the client and which includes: 30 31 • an initial care plan, if required, to address immediate needs (for 32 example, providing information and advice on drug and alcohol 33 misuse)

34 • harm reduction interventions

35 • motivational interventions to enhance retention in treatment

36 • developing and agreeing the care plan with the client and 37 implementation of the care plan — with interventions relevant to 38 each stage of the treatment journey and regular care plan reviews.

39 40 While formal psychological interventions may be delivered by a keyworker, 41 this activity is not part of the keyworking process per se. The keyworker may

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1 provide a level of ongoing face-to-face therapeutic support involving the use 2 of some psychological techniques. 3 4 Most NHS drug services in the UK tend to focus on people who misuse 5 opiates and to be dominated by substitute prescribing. People who misuse 6 cannabis tend not to be seen as a priority and are rarely included in service 7 contracts. Cocaine treatment services have been developed recently but tend 8 to lack focus and use mostly education-based approaches, for which no 9 evidence has yet been identified. 10 11 When evaluating the outcomes of the studies described below it is important 12 to consider that standard care in the United States, where most of the research 13 considered in this chapter is conducted, may involve higher levels of care and 14 regular counselling, which surpass that usually available in the UK. The 15 American Society of Addiction Medicine (ASAM, 2001) has defined standard 16 outpatient treatment in the US as organised, non-residential services with 17 designated drug misuse professionals providing regular treatment sessions 18 totalling fewer than 9 contact hours per week. Treatment might typically 19 consist of weekly individual and/or group counselling, which would aim to 20 address not only the drug misuse but also wider medical, psychological and 21 social needs. ‘Treatment as usual’ in recent US-based multi-site clinical trials 22 reflects this characterisation (for example, Peirce et al., 2006; Rawson et al., 23 2004). Timko and colleagues (2003) surveyed all 176 Veterans Affairs 24 substance misuse treatment programmes across the US and found that nearly 25 all (99%) provided some form of drug or alcohol counselling or 26 psychotherapy as part of standard outpatient care, with correspondingly high 27 (90%) utilisation by service users. 28 29 8.2 Outcomes 30 31 The primary outcomes assessed were related to abstinence and drug use. 32 Abstinence can be expressed in a variety of ways, but the two main measures 33 examined were point abstinence and duration of abstinence. Measures based 34 on urinalysis were preferred but studies reporting only self-report measures 35 were not excluded. Point abstinence refers to evidence for the absence of drug 36 use at a particular point in time (for example, end of treatment or at 12-month 37 follow-up). The main limitation of this measure is that, due to the relapsing 38 nature of drug misuse, it is not necessarily indicative of abstinence over a 39 longer period of time. For example, where a person is abstinent at the end of 40 treatment it does not indicate whether he or she used drugs less during 41 treatment than others who were not abstinent at the end of treatment. 42 43 Therefore, a measure of the duration of abstinence over a period of time is 44 also important to assess how long a person remains abstinent, and the 45 proportion of days a person is abstinent over a period of time. 46

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1 Frequency of illicit drug use is also an important measure because, although 2 abstinence may be a desired goal, reducing drug misuse may be a more 3 realistic way of reducing drug-related harm. Drug misuse is usually 4 measured by self-report, often in terms of the frequency of using particular 5 drugs over a period of time.

6 8.3 Psychological interventions alone for the management of drug 7 misuse (cocaine, cannabis and opiates)

8 8.3.1 Introduction 9 This section reviews the evidence for psychological interventions alone for the 10 treatment of drug misuse; that is, without pharmacological interventions. 11 Most of this evidence is focused on studies of drugs for which there is, as yet, 12 little or no evidence for effective pharmacological interventions or substitute 13 prescribing, for example cannabis and cocaine. 14

15 8.3.2 Definitions of interventions 16 Contingency management 17 Contingency management provides a system of incentives and disincentives 18 (although almost all studies are concerned with provision of incentives) 19 designed to make continual drug use less attractive and abstinence more 20 attractive (Griffith et al., 2000). There are three primary methods of providing 21 incentives: 22 23 • Voucher-based reinforcement: people who misuse drugs receive 24 ‘vouchers’ with various monetary values (usually increasing in 25 value after successive periods of abstinence) for providing 26 biological samples (usually urine) that are negative for the tested 27 drugs. These vouchers are withheld when the biological sample 28 indicates recent drug use. Once earned, vouchers are exchanged for 29 goods or services that are compatible with a drug-free lifestyle.

30 • Prize-based reinforcement: this is more formally referred to as the 31 ‘variable magnitude of reinforcement procedure’ (Prendergast et al., 32 2006). Participants receive draws, often from a number of slips of 33 paper kept in a fishbowl, for providing a negative biological 34 specimen. Provision of a specimen indicating recent drug use 35 results in the withholding of draws. Each draw has a chance of 36 winning a ‘prize’, the value of which varies. Typically, about half 37 the draws say ‘Good job!’ The other half result in the earning of a 38 prize, which may range in value from ₤1 to ₤100 (Prendergast et al., 39 2006).

40 • Clinic privileges: Participants receive clinic privileges for providing 41 a negative biological sample. Privileges include take-home

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1 methadone doses (for example, Stitzer et al, 1992), and changes in 2 methadone dose (for example, Stitzer et al, 1986).

3 Community reinforcement approach 4 In community reinforcement emphasis is placed on environmental 5 contingencies in aspects of life such as work, recreation, family involvement, 6 and so on, to promote a lifestyle that is more rewarding than drug misuse 7 (Roozen et al., 2004). In almost all studies, the community reinforcement 8 approach for people who misuse drugs is conducted in combination with 9 contingency management. 10 Standard cognitive behavioural therapy 11 Standard cognitive behavioural therapy is a discrete, time limited, structured 12 psychological intervention, derived from a cognitive model of drug misuse 13 (Beck et al., 1993). There is an emphasis on identifying and modifying 14 irrational thoughts, managing negative mood and intervening after a lapse to 15 prevent a full-blown relapse (Maude-Griffin, 1998). 16 Relapse-prevention cognitive behavioural therapy 17 This differs from standard cognitive behavioural therapy in the emphasis on 18 training drug users to develop skills to identify situations or states where they 19 are most vulnerable to drug use, to avoid high-risk situations, and to use a 20 range of cognitive and behavioural strategies to cope effectively with these 21 situations (Carroll & Onken, 2005). 22 Behavioural couples therapy 23 Behavioural couples therapy usually involves (a) the person who misuses 24 drugs stating his or her intention not to use drugs each day and his or her 25 partner expressing support for the former’s efforts to stay abstinent; (b) 26 teaching more effective communication skills, such as active listening and 27 expressing feelings directly; and (c) helping to increase positive behavioural 28 exchanges between partners by encouraging them to acknowledge pleasing 29 behaviours and engage in shared recreational activities (Fals-Stewart et al., 30 2002). 31 Family-based interventions 32 In this approach professionals work jointly with the person who misuses 33 drugs and his or her family members, partner or others from a wider social 34 network (for example, a close friend) to seek reduced drug use or abstinence 35 (for example, Copello et al, 2005). 36 37 Interpersonal therapy 38 Interpersonal therapy is a discrete, time limited, structured psychological 39 intervention, originally developed for the treatment of depression, that 40 focuses on interpersonal issues and where therapist and service user: a) work 41 collaboratively to identify the effects of key problematic areas related to

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1 interpersonal conflicts, role transitions, grief and loss, and social skills, and 2 their effects on current drug misuse, feelings states and/or problems; and b) 3 seek to reduce drug misuse problems by learning to cope with or resolve 4 interpersonal problem areas (Weissman et al, 2000). 5 Short-term psychodynamic interventions 6 Short-term psychodynamic interventions are derived from a psychodynamic/ 7 psychoanalytic model in which: a) therapist and patient explore and gain 8 insight into conflicts and how these are represented in current situations and 9 relationships, including the therapy relationship; b) service users are given an 10 opportunity to explore feelings and conscious and unconscious conflicts 11 originating in the past, with the technical focus on interpreting and working 12 through conflicts; c) therapy is non-directive and service users are not taught 13 specific skills such as thought monitoring, re-evaluation or problem solving. 14 Treatment typically consists of 16 to 30 sessions (Leichsenring et al, 2004). 15

16 8.3.3 Databases searched and inclusion/exclusion criteria 17 Information about the databases searched and the inclusion/ exclusion 18 criteria used for this section of the guideline is in table 1.

Table 11: Databases searched and inclusion/ exclusion criteria for clinical effectiveness of psychological interventions Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who misuse opiates, stimulants, cannabis, poly drugs Interventions CM, CBT , BCT, CRA, IPT, family-based interventions, psychodynamic interventions Outcomes Abstinence: point abstinence, duration of abstinence Drug use: frequency of using illicit drugs over a period of time 19

20 8.3.4 Studies considered10 21 The review team conducted a new systematic search for RCTs that assessed 22 the efficacy of contingency management, cognitive behavioural therapy, 23 interpersonal therapy, behavioural couples therapy, family-based 24 interventions and short-term psychodynamic interventions. 25 26 In the review of standard cognitive behavioural therapy, two trials (CRITS- 27 CHRISTOPH1999; MAUDE-GRIFFIN1998) met the eligibility criteria,

10 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 providing data on 370 participants. Both trials were for cocaine dependence 2 and were published in peer-reviewed journals. 3 4 In the review of relapse-prevention cognitive behavioural therapy, seven 5 trials (BROWN2002; CARROLL1991; MONTI1997; MCKAY2004; 6 STEPHENS1994; STEPHENS2000; STEPHENS2002) met the eligibility criteria, 7 providing data on 1,214 participants. Of these trials, four were on cocaine 8 dependence (BROWN2002; CARROLL1991; MONTI1997; MCKAY2004) and 9 three were on cannabis dependence (STEPHENS1994; STEPHENS2000; 10 STEPHENS2002). All trials were published in peer-reviewed journals. 11 12 For contingency management, 14 trials (BUDNEY2006; CARROLL2006B; 13 HIGGINS1993; HIGGINS1994; JONES2004; KADDEN2006; PETRY2004; 14 PETRY2005A; PETRY2005B; PETRY2006; RAWSON2006; ROLL2006; 15 SHOPTAW2005; SHOPTAW2006) met the eligibility criteria, providing data 16 on 1,498 participants. Of these trials, six were for cocaine dependence 17 (HIGGINS1993; HIGGINS1994; PETRY2004; PETRY2005A; PETRY2006; 18 RAWSON2006), one for cocaine and/or heroin dependence (PETRY2005B), 19 three for methamphetamine dependence (ROLL2006; SHOPTAW2005; 20 SHOPTAW2006) and three for cannabis dependence (BUDNEY2006; 21 CARROLL2006A; KADDEN2006). All trials were published in peer-reviewed 22 journals. 23 24 For behavioural couples therapy, three trials (FALS-STEWART1996; 25 KELLEY2002; WINTERS2002) met the eligibility criteria, providing data on 26 123 participants. All trials were published in peer-reviewed journals and were 27 for people who were cocaine dependent or heroin dependent (all participants 28 in these trials underwent detoxification, if required, before receiving the 29 intervention). 30 31 For psychodynamic interventions, one trial (CRITS-CHRISTOPH1999) met the 32 eligibility criteria, providing data on 247 participants. This trial was published 33 in a peer-reviewed journal and was for cocaine dependence. 34 35 For IPT, one trial (CARROLL1991) met the eligibility criteria, providing data 36 on 42 participants. This trial was published in a peer-reviewed journal and 37 was for cocaine dependence. 38 39 In addition 37 studies were excluded from the analysis. The most common 40 reason for exclusion was no drug use outcomes (further information about 41 both included and excluded studies can be found in Appendix 14). 42 43 Table 12: Study information and summary of evidence table for trials of cognitive 44 behavioural therapy versus waitlist or standard care, for people who are cocaine or 45 cannabis dependent CBT (RP) versus CBT (RP) versus standard care CBT (RP) versus standard

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waitlist for cannabis for cannabis dependence care for cocaine dependence dependence Total no. of 2 RCTs 1 RCT 4 RCTs trials (total (N = 444) (N = 212) (N = 558) no. of participants) Study ID STEPHENS2000 STEPHENS1994 BROWN2002 STEPHENS2002 CARROLL1991 MONTI1997 MCKAY2004 Problem Cannabis dependence Cannabis dependence (DSM- Cocaine dependence drug or (DSM-IV) IV) (DSM-III/III-R/IV) diagnosis Treatment 9 individual sessions 12 group sessions + 2 booster 8 sessions (MONTI1997) length (STEPHENS2002) 14 sessions at follow-up group sessions 10 sessions (STEPHENS2000) (BROWN2002)

12 sessions (CARROLL1991)

12 individual + 12 group sessions (MCKAY2004)

Length of 12 months 12 months 12 months follow-up Age 34 to 36 32 27 to 42 (years) Overall High Moderate Moderate quality of evidence Point Negative urine: Negative urine: Self-report: abstinence 4-month follow-up: 3-month follow up: RR 0.74 Endpoint: RR 1.14 RR 4.90 (2.77 to 8.85) (0.48 to 1.14) (0.96 to 1.36) K = 2, N = 444 K = 3, N = 427 12-month follow-up: RR 0.75 (0.37 to 1.51) 12-month follow-up: RR K = 1, N = 212 0.96 (0.71 to 1.29) K = 1, N = 257 Duration of - - Days in past 3 months: abstinence 3-month follow-up: SMD - 0.08 (-0.33 to 0.17) K = 1, N = 247

6-month follow-up: SMD - 0.11 (-0.34 to 0.11) K = 2, N = 301

12-month follow-up: SMD -0.13 (-0.39 to 0.13) K = 1, N = 247

Illicit drug - Days per month: Drug use in last 3 months use 3-month follow-up: SMD -0.11 (6 month follow up): (-0.41 to 0.20) SMD -0.19 (-0.68 to 0.30) 12-month follow-up: SMD - K=1 N=65 0.02 (-0.32 to 0.29) K = 1, N = 212

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1 2 Table 12: Study information and summary of evidence table for trials of cognitive 3 behavioural therapy versus waitlist or standard care, for people who are cocaine or 4 cannabis dependent (continued) CBT (S) versus standard care for CBT (RP) versus IPT for cocaine dependence cocaine dependence Total no. of 2 RCTs 1 RCT trials (total no. (N = 370) (N=42) of participants) Study ID CRITS-CHRISTOPH1999 CARROLL2002 MAUDE-GRIFFIN1998 Problem drug Cocaine dependence (DSM-III-R/IV) Cocaine dependence (DSM-III) or diagnosis Treatment 12 sessions (MAUDE-GRIFFIN1998) 12 sessions length 39 sessions (CRITS-CHRISTOPH1999) Length of 6 to 9 months 3 months follow-up Age 34 27 (years) Overall Moderate Moderate quality of evidence Point Negative urine: Endpoint: RR 1.00 Self-report: abstinence (0.78 to 1.30) 3-month follow up: RR 1.71 (0.84 to 3.48) K = 2, N = 370 K=1 N=42 Duration of - - abstinence Illicit drug use - - 5 6 Relapse-prevention cognitive behavioural therapy appeared to be effective for 7 cannabis dependence, particularly compared with waitlist control. However, 8 in one trial (Stephens et al., 1994), where the therapy was compared with a 9 support group, no significant differences were found. This may be explained 10 by the use of group therapy in this trial; individual therapy appears to be 11 more effective (for example, Stephens et al., 2002). 12 13 Neither relapse-prevention nor standard cognitive behavioural therapy was 14 effective for the treatment of cocaine dependence. No differences were found 15 for abstinence and drug misuse outcomes compared to control groups. 16 17 Table 13: Study information table for trials of contingency management for people 18 who misuse drugs CM versus CM versus CM versus CM versus CBT CM versus CBT control for control for control for (RP) for (RP) for cannabis cocaine and/or methamphet- cannabis stimulant dependence heroin use amine dependence dependence dependence Total no. of 6 RCTs 2 RCTs 2 RCTs 2 RCTs 4 RCTs trials (total (N = 742) (N = 222) (N = 183) (N = 200) (N = 375) no. of participants)

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Study ID HIGGINS1993 ROLL2006 CARROLL2006B RAWSON2006 BUDNEY2006 HIGGINS1994 SHOPTAW2006 KADDEN2006 SHOPTAW2005 CARROLL2006B PETRY2004 KADDEN2006 PETRY2005A PETRY2005B PETRY2006 Problem Cocaine Methampheta- Cannabis Cocaine Cannabis drug or dependence mine dependence dependence dependence diagnosis (DSM-III-R/IV) dependence (DSM-IV) (DSM-IV): (DSM-IV) (DSM-IV) RAWSON2006 Opiate (90%) dependence (DSM-IV): Metampheta- PETRY2005B mine dependence (DSM-IV): RAWSON2006 (10%), SHOPTAW2005 Nature of Vouchers Vouchers Vouchers Vouchers Vouchers incentive (HIGGINS1993, HIGGINS1994), Prizes (PETRY2004, PETRY2005A, PETRY2005B, PETRY2006) Treatment 12 weeks 12 weeks 8 weeks 16 weeks 8 weeks length (CARROLL2006 (CARROLL2006 B) B) 9 weeks 9 weeks (KADDEN2006) (KADDEN2006) 14 weeks (BUDNEY2006) Length of 3 to 12 months 3 to 6 months 6 to 12 months 12 months 12 months follow-up Age (years) 29 to 35 30 to 32 21 to 32 36 to 37 33

1 2 3 Table 14: Summary of evidence table for trials of contingency management for people who misuse drugs* CM versus CM versus CM versus CM versus CBT CM versus control for control for control for (RP) for CBT (RP) for cocaine and/or methamphet- cannabis stimulant cannabis heroin use amine dependence dependence dependence dependence Total no. of 7 RCTs 2 RCTs 2 RCTs 2 RCTs 4 RCTs trials (total (N = 833) (N = 222) (N = 183) (N = 200) (N = 375) no. of participants) Study ID HIGGINS1993 ROLL2006 CARROLL2006B RAWSON2006 BUDNEY2006 HIGGINS1994 SHOPTAW2006 KADDEN2006 SHOPTAW2005 CARROLL2006 JONES2004 B PETRY2004 KADDEN2006 PETRY2005A PETRY2005B PETRY2006

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Overall High Low Low Moderate Low quality of evidence Durations of Continuous Continuous Continuous Continuous Continuous abstinence duration: duration: duration: duration: duration: 3 weeks: RR 3 weeks: RR 1.24 9 weeks: RR 1.97 3 weeks: RR 1.66 6 weeks: RR 1.81 (1.47 to (0.83 to 1.86) (0.83 to 4.64) (1.11 to 2.47), 3.00 (1.25 to 2.24), K = 4, N = K = 1, N = 109 K = 1, N = 116 K = 1, N = 118 7.21) 612 12 weeks: RR 2.74 Longest Longest K = 1, N = 60 6 weeks: RR (0.89 to 8.37) duration: SMD - duration: SMD - 4.07 (2.25 to K = 1, N = 113 0.37 (-0.87 to 0.79 (-1.24 to - 9 weeks: RR 7.39) K = 3, N = 0.12) 0.34) 1.32 (0.85 to 197 Longest duration: K = 1, N = 64 K = 1, N = 82 2.04) SMD -0.22 (-0.59 K = 1, N = 115 9 weeks: RR to 0.15) Abstinent for Proportion of 3.10 (2.15 to K = 1, N = 113 past 3 months: urines negative: Longest 4.47) K = 5, N = 12-month SMD -0.66 (-1.11 duration: SMD 660 follow-up: RR to -0.22) 0.89 (0.36 to 2.24) K = 1, N = 82 -0.24 (-0.73 to 12 weeks: RR K = 1, N = 116 0.25) 4.60 (2.94 to K = 1, N = 64 7.22) K = 6, N = 741

Longest duration: SMD - 0.55 (-0.85 to - 0.25) K = 2, N = 182 Point - - Negative urine: Negative urine: Negative abstinence 3-month follow- Endpoint: RR urine: up: RR 0.97 (0.35 1.11 (0.89 to 1.39) Endpoint: RR to 2.71) 1.33 (0.66 to 6-month follow- 2.69) 6-month follow- up: RR 0.98 (0.78 up: RR 1.13 (0.62 to 1.25) K = 1, N = 60 to 2.07) K = 1, N = 67 12-month 3-month follow-up: RR follow-up: RR 0.89 (0.71 to 1.13) 0.93 (0.44 to K = 1, N = 82 1.95) K = 2, N = 129

6-month follow-up: RR 1.43 (0.82 to 2.49) K = 2, N = 129

9-month follow-up: RR 1.25 (0.37 to 4.21) K = 1, N = 60

12-month follow-up: RR 0.80 (0.41 to

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1.59) K = 2, N = 175 Illicit drug Never Days used: use abstinent: RR Endpoint: SMD 0.35 (0.16 to 0.09 (-0.34 to 0.74)** 0.53) K = 3, N = 212 6-month follow- up: SMD 0.28 (- 0.16 to 0.71)

12-month follow-up: SMD -0.15 (-0.59 to 0.28) K = 1, N = 82 *RR > 1 favours intervention; in comparisons of contingency management and relapse-prevention cognitive behavioural therapy > 1 favours contingency management SMD negative values favour intervention; in comparisons of contingency management and cognitive behavioural therapy negative values favour contingency management ** RR < 1 favours intervention 1 2 There is strong evidence that contingency management is associated with 3 much longer continuous periods of abstinence for cocaine compared to 4 control groups. People in contingency management groups were more likely 5 to be abstinent from cocaine over 3, 6, 9 and 12 continuous weeks in both 6 prize and voucher reinforcement studies. Only one study compared prize and 7 voucher reinforcement, there was a trend favouring prizes (RR =1.59; 95% CI: 8 0.94 to 2.69). More research is required to assess its efficacy for 9 methamphetamine and cannabis dependence. There were trends favouring 10 contingency management on periods of continuous abstinence for both 11 methamphetamine and cannabis. During treatment, it was associated with 12 longer periods of continuous abstinence than cognitive behavioural therapy; 13 however, this difference was not sustained at follow-up. 14 Table 15: Summary evidence table for trials of behavioural couples therapy and psychodynamic interventions for people who misuse drugs* BCT versus CBT (RP) Psychodynamic interventions versus control Total no. of 3 RCTs 1 RCT trials (total no. (N = 198) (N = 247) of participants) Study ID FALS-STEWART1996 CRITS-CHRISTOPH1999 KELLEY2002 WINTERS2002 Problem drug Primary cocaine dependence (DSM- Cocaine dependence (DSM-IV) or diagnosis III-R): FALS-STEWART1996 (51%), KELLEY2002 (38%), WINTERS2002 (22%)

Primary opiate dependence, detoxification provided if necessary before treatment (DSM-III-R): FALS- STEWART1996 (38%), KELLEY2002 (48%), WINTERS2002 (14%) Treatment 12 sessions 26-week active phase + 12 weeks

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length (monthly booster session) Length of 12 months 18 months follow-up Age range 34 to 36 years 40 years Overall quality Moderate Low of evidence Durations of Proportion days in past 3 months: Continuous duration: abstinence Endpoint: SMD -0.38 (-0.66 to -0.09) 2 months: RR 0.76 (0.55 to 1.06) K=3 N=198 K = 1, N = 247

6-month follow-up: SMD -0.52 (-0.81 to -0.24) K=3 N=198

12-month follow-up: SMD -0.34 (-0.62 to -0.06) K = 3, N = 198 Illicit drug use - Relapsed at 12 months follow-up: RR 1.04 (0.80, 1.36) K = 1, N = 247 *RR > 1 favours intervention; SMD negative values favour intervention

1 2 3 Behavioural couples therapy was consistently associated with abstinence both 4 at end of treatment and at 6- and 12-month follow up for people with primary 5 stimulant and/or heroin dependence. There was a lack of trials assessing 6 psychodynamic interventions. The one included trial did not appear to be 7 effective in terms of abstinence and illicit drug use outcomes. 8

9 8.3.5 Clinical summary 10 Stimulant misuse — People presenting to treatment with stimulant misuse 11 (including cocaine and amphetamines) receiving contingency management 12 were more likely to be abstinent for longer periods of time during treatment 13 than people in the control group. Both prize- and voucher-based 14 reinforcement were found to be effective. In contrast, contingency 15 management for cannabis did not appear as effective during treatment as for 16 cocaine, although there was a trend towards favouring contingency 17 management, this was evident at follow-up. Psychodynamic therapy was also 18 ineffective during treatment and at follow-up in significantly reducing 19 cocaine use. Direct comparisons of relapse-prevention cognitive behavioural 20 therapy and contingency management for stimulant misuse demonstrated the 21 superior effectiveness of contingency management during treatment but not 22 at follow-up. It is unclear whether the lack of difference between contingency 23 management and relapse-prevention cognitive behavioural therapy at follow- 24 up is due to a delay in the benefits of cognitive behavioural therapy, being 25 observable only at follow-up, and/or a weakening of the effects of 26 contingency management after treatment has ended. 27

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1 Cannabis misuse — In contrast, relapse-prevention cognitive behavioural 2 therapy focused on drug misuse and relapse prevention strategies was 3 effective for people with cannabis-related problems when compared to no 4 intervention (a waitlist control), but a statistically significant benefit for group 5 relapse-prevention cognitive behavioural therapy was not seen when 6 compared to standard case management. It appears individual therapy may 7 be more effective than group therapy. This would suggest the provision of 8 individual relapse-prevention cognitive behavioural therapy alone for the 9 treatment of cannabis misuse would be appropriate. It should be noted that 10 the population in these studies had long-standing problematic cannabis 11 misuse of an average of 15 years’ duration. 12 13 Opiate and stimulant misuse — Individuals with cocaine and/or opiate 14 dependence and who have contact with a family member or carer benefit 15 from behavioural couples therapy both during treatment and at follow-up. 16

17 8.3.6 Clinical practice recommendations

18 8.3.6.1 Drug misuse services should introduce contingency 19 management programmes to reduce illicit drug use, promote 20 abstinence and/or promote engagement in services for people who 21 primarily misuse stimulants.

22 8.3.6.2 Healthcare professionals should consider the use of 23 individual cognitive behavioural therapy for people who present with 24 problematic cannabis use. The cognitive behavioural therapy should 25 be focused on drug use and should: 26 • consist of at least 12 weekly sessions 27 • focus on the identification of situations or states in which the 28 service user is most vulnerable to drug use 29 • focus on skills training to help the service user to cope in such 30 situations or states.

31 8.3.6.3 Cognitive behavioural therapy should not be routinely 32 provided for people presenting for treatment of stimulant misuse or 33 for people receiving methadone maintenance treatment.

34 8.3.6.4 Behavioural couples therapy should be considered for 35 people who are in close contact with a partner, family member or 36 carer and who misuse cocaine, heroin and/or have completed opiate 37 detoxification. These interventions should: 38 • focus on the service user’s drug misuse 39 • consist of at least 12 weekly sessions 40 • be based on cognitive behavioural principles. 41

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1 8.4 Psychological interventions in combination with opiate agonist 2 maintenance treatment

3 8.4.1 Introduction 4 The use of psychological interventions in combination with drug maintenance 5 treatment is by far the most common application of psychological 6 interventions in UK statutory drug treatment services. The most widely used 7 of the drug treatments is methadone, originally pioneered by Dole and 8 Nyswander (1965) as a treatment for heroin dependence. Less commonly 9 prescribed is buprenorphine which is a partial opiate agonist but which along 10 with methadone is an accepted maintenance treatment for opiate misuse 11 (NICE, 2006 TA). The rationale for maintenance treatment is that, by using a 12 synthetic opiate, cravings are relieved and, by switching from heroin to a 13 controlled drug, risks and harms associated with illicit drug use can be 14 reduced (for example, injecting behaviour and illegal activities associated 15 with obtaining drugs) and stability can be increased. This stability may create 16 a platform from which to continue psychological work in order to cope with 17 the risk of relapse, deal with associated problems and eventually aim to 18 achieve abstinence and develop a drug-free lifestyle. 19 20 As previously discussed, current practice is very varied in the UK. The most 21 common scenario is for people on a maintenance prescription to have regular 22 contact with a worker where practical issues are discussed and reviewed. 23 Furthermore, it is rare in UK services to deliver psychological interventions 24 specifically focused on attempting to reduce illicit drug use within methadone 25 maintenance or buprenorphine maintenance treatment programmes. Most 26 commonly, a significant proportion of people in these programmes continue 27 to experience a range of difficulties with other substances, including illicit 28 drugs and alcohol. 29

30 8.4.2 Databases searched and inclusion/exclusion criteria 31 Information about the databases searched and the inclusion/ exclusion 32 criteria used for this section of the guideline is in Table 16. 33 34 Table 16: Databases searched and inclusion/exclusion criteria for clinical 35 effectiveness of psychological interventions in combination with opiate agonist 36 maintenance treatment

Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who are receiving opiate agonist maintenance treatment and who misuse an additional opiate, stimulant and/or cannabis Interventions Pharmacological maintenance treatment: buprenorphine, methadone Psychological interventions: BCT, CRA, CM, CBT, family-based interventions, STPT, IPT Outcomes Abstinence: point abstinence, duration of abstinence

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Drug use: frequency of using illicit drugs over a period of time

1 8.4.3 Studies considered11 2 The review team conducted a new systematic search for RCTs that assessed 3 the efficacy and/or safety of contingency management, cognitive behavioural 4 therapy, behavioural couples therapy, short-term psychodynamic therapy, 5 family-based interventions, and interpersonal therapy in combination with 6 opiate agonist maintenance treatment. 7 8 For methadone maintenance treatment in combination with standard 9 cognitive behavioural therapy, one trial (WOODY1983) met the eligibility 10 criteria, providing data on 78 participants. This trial was published in a peer- 11 reviewed journal. 12 13 In the review of methadone maintenance treatment in combination with 14 relapse-prevention cognitive behavioural therapy, three trials (EPSTEIN2003; 15 RAWSON2002; UKCBTMM2004) met the eligibility criteria, providing data 16 on 146 participants. One trial (UKCBTMM2004) was unpublished (a full trial 17 report was obtained from the authors) and two trials were published in peer- 18 reviewed journals. 19 20 For methadone maintenance treatment in combination with contingency 21 management, 12 trials (CHUTUAPE2001; EPSTEIN2003; MCLELLAN1993; 22 PETRY2002; PETRY2005C; PEIRCE2006; PRESTON2000; RAWSON2002; 23 SCHOTTENFELD2005; SILVERMAN1998; SILVERMAN2004; STITZER1992) 24 met the eligibility criteria, providing data on 1,436 participants. All trials were 25 published in peer-reviewed journals between 1992 and 2006. 26 27 For buprenorphine maintenance treatment in combination with contingency 28 management, three trials (GROSS2006; KOSTEN2003; SCHOTTENFELD2005) 29 met the eligibility criteria, providing data on 202 participants. All trials were 30 published in peer-reviewed journals. 31 32 For behavioural couples therapy, one trial (FALS-STEWART2003) met the 33 eligibility criteria, providing data on 36 participants. This trial was published 34 in a peer-reviewed journal. 35 36 For family-based interventions, one trial (CATALANO1999) met the eligibility 37 criteria providing data on 132 participants. This trial was published in a peer- 38 reviewed journal. 39

11 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 For psychodynamic interventions, two trials (WOODY1983; WOODY1995) 2 met the eligibility criteria, providing data on 150 participants. All trials were 3 published in peer-reviewed journals. 4 5 In addition 24 studies were excluded. The most common reason for exclusion 6 was not providing extractable data (further information about both included 7 and excluded studies can be found in Appendix 14). 8 9 For the review of implementing contingency management a further 8 studies 10 met the eligibility criteria; three focused on patient based outcomes 11 (PETRY2001, SHOPTAW2006, LAWENTAL2006,) four focused on staff 12 attitudes (WILLENBRING2004, MCGOVERN2004, KIRBY2006; RITTER2006) 13 and one focused on both staff attitudes and organisational development ( 14 KELLOGG2005). All studies were published in peer-reviewed journals. 15 16 Table 17: Study information table for trials of CBT and contingency management 17 for people in opiate agonist maintenance treatment CBT (RP) versus CBT (S) versus CM versus standard care CM versus standard care standard care within within MMT standard care within MMT MMT within BMT Total no. of 3 RCTs 1 RCT 12 RCTs 3 RCTs trials (total (N = 146) (N = 78) (N = 1,436) (N = 202) no. of participants) Study ID EPSTEIN2003 WOODY1983 CHUTUAPE2001 GROSS2006 RAWSON2002 EPSTEIN2003 KOSTEN2003 UKCBTMM2004 MCLELLAN1993 SCHOTTENFELD PETRY2002 2005 PETRY2005C PEIRCE2006 PRESTON2000 RAWSON2002 SCHOTTENFELD2005 SILVERMAN1998 SILVERMAN2004 STITZER1992 Problem drug Opiate dependence Opiate dependence Opiate dependence Opiate or diagnosis (MMT) (MMT) (MMT) dependence (buprenorphine Cocaine Cocaine: maintenance) dependence (DSM- SILVERMAN1998 III-R/IV): EPSTEIN2003, Cocaine dependence RAWSON2002 (DSM-III-R/IV): PETRY2002, 2005C, RAWSON 2002, EPSTEIN2003, SILVERMAN2004 Nature of N/A N/A Vouchers Vouchers incentive (EPSTEIN2003; PRESTON2000; RAWSON2002; SILVERMAN1998; SILVERMAN2004; SCHOTTENFELD2005)

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Prizes (PETRY2002; PETRY2005C; PEIRCE2006)

Take home methadone (CHUTUAPE2001; MCLELLAN1993; SILVERMAN2004; STITZER1992)

Treatment 12 weeks 26 weeks 8 weeks (PRESTON2000) 12 weeks length 12 weeks (EPSTEIN2003; (GROSS2006; PETRY2002; SCHOTTENFELD PEIRCE2006; 2005) PETRY2005C; SCHOTTENFELD2005SI 24 weeks LVERMAN1998 (KOSTEN2003) 16 weeks (RAWSON2002) 25 weeks (STITZER1992) 26 weeks (MCLELLAN1993) 34 weeks (CHUTUAPE2001) 52 weeks (SILVERMAN2004) Length of 0 to 12 months 12 months 0 to 15 months 3 to 6 months follow-up Age (years) 27 to 42 33 35 to 44 32 to 37 1 2 3 4 Table 17: Study information table for trials of CBT and contingency 5 management for people in opiate agonist maintenance treatment (continued)* CBT (RP) versus CBT (S) versus CM versus standard CM versus standard standard care Standard care within care within MMT care within within MMT MMT buprenorphine maintenance treatment Total no. of 3 RCTs 1 RCT 12 RCTs 3 RCTs trials (total no. (N = 146) (N = 78) (N = 1,436) (N =163) of participants) Study ID EPSTEIN2003 WOODY1983 CHUTUAPE2001 GROSS2006 RAWSON2002 EPSTEIN2003 KOSTEN2003 UKCBTMM2004 MCLELLAN1993 SCHOTTENFELD PETRY2002 2005 PETRY2005C PEIRCE2006 PRESTON2000 RAWSON2002 SCHOTTENFELD 2005 SILVERMAN1998 SILVERMAN2004

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STITZER1992 Overall Low Low High Low quality of evidence Durations of Cocaine - Cocaine and opiates 8 weeks continuous abstinence Continuous Continuous duration: abstinence: RR 1.10 duration: 3 weeks: RR 2.06 (1.20 (0.30 to 4.11) 3 weeks: RR 1.50 to 3.54) K=1 N=82 (0.72 to 3.14) K = 5, N = 278 K = 1, N = 60 Longest duration: 6 weeks: RR 4.17 (2.42 SMD 0.12 Heroin to 7.18) (-0.18 to 0.43) Proportion days K = 4, N = 198 K = 2, N = 162 abstinent: Change from 8 weeks: RR 3.87 (2.61 Opiates baseline: SMD to 5.74) K = 6, N = Longest duration: -0.17 (-0.74 to 667 SMD -0.26 0.39) (-0.69 to 0.18) K = 1, N = 49 12 weeks: RR 3.08 K = 1, N = 83 (1.73 to 5.47) K = 5, N = 582 Cocaine and opiates Continuous duration: 26 weeks: RR 23.00 8 weeks: RR 1.10 (1.43 to 371.00) (0.30 to 4.11) K = 1, N = 52 K = 1, N = 83

Longest duration: SMD 0.06 (-0.21 to 0.34) K = 3, N = 202

Total duration: SMD 0.50 (-0.13 to 1.13) K = 1, N = 40 Point Cocaine - Negative urine for - abstinence 12-month follow- cocaine and opiates: up: RR 2.25 (1.16 Endpoint: RR 2.65 to 4.36) (1.46 to 4.79) K = 1, N = 60 K = 2, N = 137

6-month follow-up: RR 1.81 (1.07 to 3.06) K = 2, N = 137

12-month follow-up: RR 2.00 (1.01 to 3.95) K = 1, N = 60 Drug use Opiates Opiates Never abstinent from - Endpoint, change Endpoint, change from cocaine or opiates: from baseline: baseline: SMD 0.07 RR 0.63 (0.30 to 1.35) SMD 0.12 (-0.40 to 0.54) K = 4, N = 218 (-0.28 to 0.52) K = 1, N = 69 K = 2, N = 146 Cocaine 6 to 12 months Endpoint, change from follow-up, baseline: change from SMD -0.23 (-0.70 to baseline: SMD 0.25) 0.04 (-0.29 to 0.36) K = 1, N = 69 K = 2, N = 146 *RR > 1 favours intervention; SMD negative values favour intervention

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1 2 Relapse-prevention and standard cognitive behavioural therapy do not 3 appear to be effective in reducing elicit drug use for people undergoing 4 methadone maintenance treatment. The majority of trials found no benefit for 5 either form of cognitive behavioural therapy in comparison with control 6 groups for abstinence and reduction in illicit drug use. Consistent with the 7 evidence above of contingency management for cocaine misuse, there is good 8 evidence that contingency management for people undergoing methadone 9 maintenance treatment is strongly and consistently associated with longer 10 periods of continuous periods of abstinence during treatment and point 11 abstinence at 6- and 12-month follow-up. These findings were consistent for 12 studies using vouchers, prizes and privileges as reinforcers. 13 14 However, the evidence of contingency management for people undergoing 15 buprenorphine maintenance treatment is absent. It appears that contingency 16 management is not associated with improved abstinence and illicit drug use 17 outcomes for this population. 18 19 Table 18: Study information and summary of evidence table for trials of family- 20 based and psychodynamic interventions for people in methadone maintenance 21 treatment* BCT versus standard Family-based Psychodynamic Psychodynamic care within MMT intervention versus interventions versus interventions versus standard care within standard care within CBT (S) within MMT MMT MMT Total no. of 1 RCT 1 RCT 2 RCTs 1 RCT trials (total (N = 36) (N = 132) (N = 150) (N = 56) no. of participants) Study ID FALS-STEWART CATALANO1999 WOODY1983 WOODY1983 2001 WOODY1995

Problem drug Opiate dependence Opiate dependence Opiate dependence Opiate dependence or diagnosis (MMT) (MMT) (MMT) (MMT) Treatment 12 weeks 32 weeks 6 to 26 weeks 26 weeks length Length of 3 months 12 months 12 months 12 months follow-up Age (years) 34 35 34 to 36 30 Overall Moderate Moderate Low Low quality of evidence Point - - - - abstinence Illicit drug Endpoint: SMD -1.22 Illicit opiate use: Illicit opiates Opiates use (-1.94 to -0.50) Endpoint: SMD -0.47 Days used: Days used: K = 1, N = 36 (-0.82 to -0.12) Endpoint: SMD -0.04 Endpoint: SMD -0.08 (-0.37 to 0.30) (-0.56 to 0.41) Cocaine use: K = 2, N = 150 K = 1, N = 65 Endpoint: SMD -0.34 (-0.68 to 0.01) Stimulants Days used: Stimulants Cannabis use: Endpoint: SMD -0.38 Days used: Endpoint: SMD -0.16 (-0.72 to -0.05) Endpoint: SMD 0.00

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(-0.51 to 0.18) K = 2, N = 150 (-0.49 to 0.49) K = 1, N = 56

*RR > 1 favours intervention; negative SMD values favour intervention; in the comparison of psychodynamic interventions and standard cognitive behavioural therapy, negative values favour psychodynamic interventions 1 2 Consistent with the evidence reviewed above of primary stimulant or heroin 3 misuse, behavioural couples therapy and family-based interventions for 4 people undergoing methadone maintenance treatment were associated with 5 reductions in illicit drug use. Psychodynamic interventions did not appear to 6 be effective for reducing illicit opiate use for people undergoing methadone 7 maintenance treatment but there was some evidence for benefit on the 8 secondary outcome of stimulant use. 9

10 8.4.4 Health economics

11 Literature review of health economic evidence 12 A systematic literature review of economic evidence on drug misuse and its 13 effective treatments was performed using a wide range of standard 14 bibliographic databases (summarised in Appendix 10). Relevant publications 15 were assessed for internal validity using standard methods of health 16 economic appraisal. An adaptation of the 35-point checklist used by the 17 British Medical Journal (Drummond and Jefferson, 1996) was utilised to 18 assess eligibility for inclusion in the guideline. Additional references were 19 identified by handsearching or, in some instances, as a courtesy from authors 20 whose studies were accepted into press. From this review, data were 21 extracted by the health economists, summarised on a data extraction table, 22 and presented for comparison in a cost-effectiveness model in accordance 23 with standard principles of health economic appraisal. 24 Introduction — rationale for economic modelling and comparison of 25 interventions 26 Provision of contingency management for people undergoing methadone 27 maintenance treatment who misuse cocaine and/or illicit opiates was 28 identified by the GDG as an area with potential major resource implications. 29 Therefore, a decision-analytic model was developed in order to assess the cost 30 effectiveness of contingency management versus standard care for cocaine 31 and illicit opiate users under methadone maintenance treatment in the UK. 32 Contingency management was defined as involving regular contact with a 33 case worker over 12 weeks, combined with reinforcement in the form of 34 vouchers exchangeable for retail goods and services awarded to the user 35 when weekly abstinence from cocaine and/or opiate use was achieved. 36 Standard care consisted of less regular contact with a case worker over the 12- 37 week period. 38 Economic model structure

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1 A decision tree was developed to assess the costs and benefits associated with 2 contingency management and standard care over 52 weeks. According to the 3 model structure, a hypothetical cohort of people misusing cocaine and/or 4 illicit opiates under methadone maintenance treatment received either 5 contingency management or standard care over 12 weeks. All people in the 6 cohort underwent urinalysis for the detection of cocaine and/or opiates every 7 time they contacted a case worker. Service users receiving contingency 8 management were awarded a voucher exchangeable for retail goods and 9 services for every week they remained abstinent over the 12 weeks of 10 treatment. After the 12-week intervention period, the cohort was followed for 11 a further 40 weeks and underwent further urinalysis. Service users who had 12 received contingency management were awarded vouchers if they were 13 found abstinent at 24, 36 or 52 weeks. 14 Costs and health benefits included in the analysis 15 The economic analysis adopted the perspective of the NHS. Health service 16 costs included intervention costs and additional healthcare costs such as those 17 associated with Accident and Emergency (A&E) attendances, and primary 18 and secondary care for physical health problems, as well as mental healthcare. 19 A further analysis considering a wider NHS and criminal justice system 20 perspective was also undertaken, as the economic impact of drug misuse on 21 the criminal justice system was considered to be significant. 22 23 The measure of health benefit used in the analysis was the number of weeks 24 people in the study population remained abstinent from cocaine and illicit 25 opiates. Estimation of health benefits in the form of quality adjusted life years 26 (QALYs) was not possible, as appropriate data on the health-related quality of 27 life of the study population (that is, utilities for the health state of abstinence 28 from cocaine and illicit opiates following treatment and for the health state of 29 lack of abstinence despite treatment) were not available in the literature. 30 31 Effectiveness data utilised in the model 32 Effectiveness data used in the model were derived from meta-analyses of 33 RCTs that compared the effectiveness of contingency management and 34 standard care in the study population, which were included in the systematic 35 review of clinical studies undertaken for the guideline. Data for the 12-week 36 period of treatment were taken from studies reporting outcomes in the form 37 of percentage of service users undergoing methadone maintenance treatment 38 remaining abstinent from cocaine and opiates over a minimum number of 39 consecutive weeks during the period of treatment. Follow-up data were based 40 on studies that reported outcomes in the form of percentage of service users 41 that were abstinent at the end of treatment, at 6 months and at one year of 42 follow-up. Table 19 presents the effectiveness data used in the economic 43 analysis and the clinical studies from which they were derived. Details of the 44 clinical studies are provided in Appendix 14. 45

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Table 19: Effectiveness data utilised in the economic model

Data derived from the guideline meta-analysis Studies included A. Percentage of users abstinent over a minimum of 1 week during treatment Intervention Mean 95% CI PETRY2002 CM 70.59% 58.13% to 80.70% PRESTON2000 SILVERMAN1998 Standard care 48.57% 36.57% to 60.72% RR 1.47 1.10 to 1.96 (fixed-effects model) B. Percentage of users abstinent over a minimum of 2 weeks during treatment Intervention Mean 95% CI PETRY2002 CM 61.76% 49.14% to 73.04% PRESTON2000 SILVERMAN1998 Standard care 28.57% 18.72% to 40.80% RR 2.19 1.44 to 3.34 (fixed-effects model) C. Percentage of users abstinent over a minimum of 3 weeks during treatment Intervention Mean 95% CI PETRY2002 PRESTON2000 CM 52.17% 43.54% to 60.68% SCHOTTENFELD2005 Standard care 27.14% 20.14% to 35.42% SILVERMAN1998 RR 2.06 1.20 to 3.54 (random-effects model) RAWSON2002 D. Percentage of users abstinent over a minimum of 6 weeks during treatment Intervention Mean 95% CI PETRY2002 CM 46.59% 35.99% to 57.49% PRESTON2000 Standard care 12.73% 7.39% to 20.76% SCHOTTENFELD2005 RR 4.17 2.42 to 7.18 (fixed-effects model) SILVERMAN1998 E. Percentage of users abstinent over a minimum of 8 weeks during treatment Intervention Mean 95% CI MCLELLAN1993 PETRY2002 CM 27.46% 22.82% to 32.63% PEIRCE2006 Standard care 7.23% 4.78% to 10.71% PRESTON2000 RR 3.87 2.61 to 5.74 (fixed-effects model) SCHOTTENFELD2005 SILVERMAN1998 F. Percentage of users abstinent over 12 weeks during treatment Intervention Mean 95% CI MCLELLAN1993 PETRY2002 CM 12.33% 8.89% to 16.79% PEIRCE2006 Standard care 4.14% 2.26% to 7.31% SILVERMAN1998 RR 3.08 1.73 to 5.47 (fixed-effects model) SILVERMAN2004 G. Percentage of users abstinent at end of treatment Intervention Mean 95% CI PETRY2005C CM 42.86% 31.28% to 55.22% RAWSON2002 Standard care 16.42% 8.87% to 27.91% RR 2.65 1.46 to 4.79 H. Percentage of users abstinent at 6-month follow-up Intervention Mean 95% CI PETRY2005C CM 40.00% 28.69% to 52.41% RAWSON2002 Standard care 22.39% 13.47% to 34.52% RR 1.81 1.07 to 3.06 I. Percentage of users abstinent at 1-year follow-up Intervention Mean 95% CI RAWSON2002 CM 53.33% 34.64% to 71.20% Standard care 26.67% 12.98% to 46.18% RR 2.00 1.01 to 3.95 1 2 It must be noted that data referring to the 12-week treatment report the 3 longest minimum consecutive period of abstinence achieved by the users. 4 That means that if a user remained abstinent, for example, over 6 consecutive

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1 weeks, then used cocaine and/or opiates for a short period and subsequently 2 remained abstinent for another 3 weeks, this latter period of abstinence was 3 not reported in the studies. Owing to lack of such data, it was conservatively 4 assumed in the analysis that each user had only one period of consecutive 5 weeks in abstinence during treatment, lasting 1 week at the minimum and 12 6 weeks at the maximum. The percentages of users who remained abstinent 7 over consecutive periods of weeks during treatment that were not reported in 8 the trials (for example, over 4 weeks, 5 weeks, and so on) were estimated 9 assuming that the percentage of users remaining abstinent over an increasing 10 number of weeks (between periods of consecutive weeks for which data was 11 available) declined at a constant rate. In order to estimate the percentages of 12 service users remaining abstinent within each week between the end of 13 treatment and one year follow-up, it was assumed that the percentage of 14 service users being abstinent over each week changed at a constant rate 15 between the time points for which relevant data were reported in the 16 literature. 17 Cost data 18 Estimation of costs was based on deterministic costing of relevant resources. 19 Resource utilisation was estimated and subsequently combined with unit 20 prices to provide total costs associated with each arm of the model. Resource 21 utilisation regarding the interventions assessed, reflecting UK clinical 22 practice, was based on the GDG expert opinion. For each intervention, the 23 GDG estimated the number of contacts with case workers over 12 weeks. In 24 every such contact a urinalysis test (dipstick) was undertaken for the 25 detection of cocaine and/or opiates. Users in the contingency management 26 arm were assumed to receive a £10 voucher for each week they remained 27 abstinent from cocaine and opiates during the 12-week treatment, and £20 28 vouchers each time they were found to be abstinent in checks performed at 29 24, 36 and 52 weeks. Costs of methadone maintenance treatment as well as 30 follow-up costs up to a year from the start of the model were excluded from 31 the analysis, as they were common to the two arms of the model. Case-worker 32 unit costs (assumed to be equivalent to those of community psychiatric nurses 33 [CPNs]) were taken from Curtis & Netten (2005). The price of urine dipsticks 34 was determined by personal communication with a pharmacist. Resource 35 utilisation estimates and unit costs associated with contingency management 36 and standard care are presented in Table 20. 37 38 39 40 Table 20: Resource utilisation estimates and unit costs associated with contingency management and standard care Resource utilisation (GDG opinion)

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CM Weeks 1–3: 3 contacts per week with a case worker, lasting 30 min each Weeks 4–6: 2 contacts per week with a case worker, lasting 30 min each Weeks 7–12: 1 contact per week with a case worker, lasting 30 min Plus: urinalysis (dipstick) at every contact

Reinforcers: £10 voucher per week of abstinence during the 12-week treatment £20 voucher for abstinence in checks performed at 24, 36 and 52 weeks

Standard care Weeks 1–12: 1 contact per fortnight with a case worker, lasting 30 min Plus: urinalysis (dipstick) at every contact Unit costs Case worker per hour of clinic contact: £56 Curtis & Netten (2005); cost of CPN excluding qualification costs Urinalysis (dipstick): £2 Personal communication with a pharmacist 1 2 Additional healthcare costs, including costs associated with A&E attendances, 3 GP visits and inpatient care for physical health problems, as well as inpatient 4 and outpatient mental healthcare, were derived from Godfrey and colleagues 5 (2002). The study estimated the annual healthcare cost incurred by Class A 6 problem drug users in England and Wales, excluding treatment for 7 dependence. Costs were reported separately for users not in treatment for 8 dependence and those already in treatment; costs incurred by the latter were 9 utilised in the economic analysis. It must be noted that additional healthcare 10 costs estimated by Godfrey and colleagues were not adjusted to take into 11 account the impact of current drug use on future healthcare demands. As a 12 consequence, potential future costs from infectious disease risks among users 13 of cocaine and illicit opiates were not included in the estimation of healthcare 14 costs. Criminal justice costs were also based on Godfrey and colleagues (2002). 15 As with healthcare costs, annual criminal justice costs incurred by Class A 16 problem drug users undergoing formal drug treatment were used. 17 18 It was assumed in the model that service users did not incur any additional 19 healthcare costs (apart from intervention and methadone maintenance 20 treatment costs) or criminal justice costs for periods within the time frame of 21 the analysis over which they were abstinent from cocaine and illicit opiates. 22 This is a rather strong assumption, especially for service users found to be 23 abstinent only for short time periods, such as 1–2 weeks, and is acknowledged 24 as a limitation of the analysis. 25 26 Costs were adjusted to 2005 prices using the hospital and community health 27 services pay and price inflation index (Curtis & Netten, 2005). Discounting 28 was not applied, as the time horizon of the analysis was 1 year. Table 21 29 provides all cost data utilised in the base-case economic analysis. 30 Table 21: Cost data utilised in the economic model

Cost parameter Cost (2005 prices) Source — comments

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Intervention Cost of staff from Curtis & Netten (2005); costs of CM £630 dipsticks from personal communication; cost of Standard care £180 reinforcers in the form of vouchers not included. For more details see Table 20. Additional annual £1,418 Godfrey et al. (2002); cost for Class A problem healthcare cost drug users undergoing treatment for dependence, excluding cost of treatment for dependence Annual criminal £8,657 Godfrey et al. (2002); cost for Class A problem justice cost drug users undergoing treatment for dependence 1 2 Sensitivity analysis 3 In addition to the base-case analysis, which utilised the most accurate data 4 available, a sensitivity analysis was undertaken to investigate the robustness 5 of the results under the uncertainty characterising the model input 6 parameters. Selected input parameters were varied over a range of values and 7 the impact of these variations on the results was explored. The following 8 input parameters were tested in sensitivity analysis: 9 • Relative risks (RRs) of the percentage abstinence over a consecutive 10 number of weeks during treatment or at follow-up, of service users 11 receiving contingency management versus standard care. The 95% 12 confidence intervals (CIs) of RRs calculated in the guideline meta- 13 analyses, as shown in Table 19, were used. Two scenarios examined 14 the simultaneous use of the lower 95% CIs and the upper 95% CIs 15 of all estimated RRs, respectively.

16 • Costs of vouchers received by abstinent service users undergoing 17 contingency management. A 100% increase and a 50% decrease in 18 the total value of vouchers were tested.

19 • Additional healthcare costs and criminal justice costs. Lowest and 20 highest estimates as reported in Godfrey and colleagues (2002) were 21 used.

22 Method of presentation of the results 23 The results of the economic analysis are presented in the form of incremental 24 cost-effectiveness ratios (ICERs), expressing additional cost per additional 25 unit of benefit associated with one intervention versus another (in this case an 26 additional week of abstinence achieved). In the case of an intervention being 27 more effective (that is, providing greater benefit) and less costly than its 28 comparator, the calculation of such a ratio is not required; the intervention is 29 clearly more cost effective than its comparator, and is characterised as the 30 dominant option. 31 32 33 Results 34 Base-case analysis

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1 Contingency management was more effective than standard care, as it 2 resulted in a higher number of weeks of abstinence from cocaine and illicit 3 opiates in the study population over 1 year. From the NHS perspective, it was 4 more costly than standard care, resulting in an ICER of £18 per additional 5 week of abstinence achieved. 6 7 When criminal justice costs were considered in the analysis, contingency 8 management was the dominant option, as, in addition to being more effective, 9 it also led to cost savings compared to standard care. Full results of the 10 analysis are provided in Table 22. 11 Table 22: Results of the economic analysis: total average costs and benefits per user under contingency management or standard care, over a year of follow-up A. NHS perspective Intervention Average total cost Average number of Cost effectiveness weeks of abstinence CM £1,514 22.51 ICER of CM versus standard Standard care £1,298 11.03 care: £18 per additional Difference £216 11.49 week of abstinence achieved B. NHS + criminal justice system perspective Intervention Average total cost Average number of Cost effectiveness weeks in abstinence CM £6,417 22.51 CM dominates standard Standard care £8,119 11.03 care Difference -£1,702 11.49 12 13 As indicated by the base-case results, contingency management was shown to 14 be clearly cost effective from the wider perspective of the NHS and the 15 criminal justice system. 16 17 In order to interpret the ICER of contingency management versus standard 18 care when the narrower NHS perspective was considered, the minimum 19 required improvement in health-related quality of life (HRQoL) was 20 calculated, characterised by a week of abstinence from cocaine and illicit 21 opiates in the study population, that would make the estimated ICER 22 (transformed into £/QALY) fall below the NICE-set threshold of 23 £30,000/QALY12. Using this upper threshold seemed reasonable given the 24 wide effect of drug misuse on various aspects of users’ lives, such as personal 25 relationships and social functioning; the limited effectiveness of other 26 interventions aimed at reducing the prevalence of drug misuse; the special 27 risks associated with drug injection, such as the risk of contracting and 28 spreading HIV and hepatitis B, which have a substantial economic impact on 29 the NHS, and which may be considerably reduced if long-term user 30 abstinence is achieved; and the wider financial and non-financial implications 31 for society of drug misuse. It was estimated that abstinence from cocaine and

12 http://www.nice.org.uk/page.aspx?o=201973

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1 illicit opiates needed to reflect at least a 0.03 improvement in the HRQoL of 2 users under methadone maintenance treatment (on a scale of 0–1), in order for 3 the base-case ICER to fall below the £30,000/QALY threshold. This level of 4 improvement in HRQoL was deemed to be a realistic estimate, and therefore 5 contingency management was considered a cost-effective intervention from 6 the perspective of the NHS. 7 8 Sensitivity analysis 9 Results were robust in the majority of the scenarios explored in sensitivity 10 analysis. Varying the value of vouchers and the additional healthcare and 11 criminal justice costs had no impact on the base-case results. From the NHS 12 perspective, the ICER of contingency management versus standard care 13 varied between £4 and £25 per additional week of abstinence achieved; this 14 range required only a slight improvement in HRQoL owing to abstinence, 15 between 0.01 and 0.04 (on a scale of 0–1), in order for contingency 16 management to be cost effective according to the NICE cost-effectiveness 17 threshold of £30,000/QALY gained. From the wider NHS and criminal justice 18 system perspective, contingency management remained the dominant 19 strategy. 20 21 Results were sensitive to changes in the RRs of the percentage abstinence 22 achieved by users receiving contingency management versus standard care. 23 When the lower 95% CIs of all RRs were used, the ICER of contingency 24 management versus standard care, from the NHS viewpoint, rose to £218 per 25 additional week of abstinence achieved, which translated into a minimum 26 0.38 improvement in HRQoL related to abstinence (on a scale of 0–1), in order 27 for contingency management to remain cost effective according to the NICE 28 cost-effectiveness threshold. However, the value of 0.38 was deemed to be 29 higher than the actual improvement in HRQoL experienced by users in 30 periods of abstinence, and therefore contingency management was not cost 31 effective from the NHS perspective in this scenario. Regarding the wider NHS 32 and criminal justice system viewpoint, contingency management was more 33 costly than standard care, with an ICER of £51 per additional week of 34 abstinence achieved. This meant that a minimum improvement of 0.09 (on a 35 scale of 0–1) in HRQoL was required in order for the contingency 36 management to be cost effective according to the NICE-set threshold, which 37 was considered a realistic figure. When the upper 95% CIs of all RRs were 38 used, contingency management dominated standard care from both 39 perspectives examined. It must be noted that the base-case results were robust 40 under changes in the RRs of abstinence rates referring to the 12-week period 41 of treatment only (that is, when RRs of abstinence rates achieved at follow-up 42 remained intact). It was therefore the uncertainty characterising the follow-up 43 data used in the analysis that strongly affected the results. 44 45 Limitations of the economic analysis and overall conclusions

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1 The results of the analysis are subject to various limitations. In order to utilise 2 the available efficacy data, a number of assumptions were required. It was 3 assumed that users had only one period of consecutive weeks of abstinence, 4 as only one (that is the longest) such period was recorded for every user in the 5 trials considered in the analysis. Rates of abstinence for periods of consecutive 6 weeks in treatment not reported in the trials were extrapolated from existing 7 data. Follow-up data on abstinence were derived from a limited number of 8 studies, and referred to three different time points only: end of treatment, 6 9 months and one year. Such evidence may not accurately reflect abstinence 10 trends among users over time, which means that estimation of weekly 11 abstinence rates over one year, required for the construction of the economic 12 model, by extrapolating available follow-up data, is subject to uncertainty. 13 14 Intervention costs were based on GDG estimates of relevant resource use, 15 owing to lack of research-based data. Other healthcare costs included in the 16 analysis were based on a UK study. However, that study (and consequently 17 the economic analysis as well) did not take into account long-term costs 18 associated with drug misuse, such as costs associated with infectious disease 19 risks among users of cocaine and illicit opiates which may impose a 20 significant burden on the health service. Costs related to neonatal care of 21 infants born to mothers misusing cocaine and/or opiates were also not 22 considered in the analysis, although there is evidence that maternal drug 23 misuse and subsequent care of infants born to drug users may also impose a 24 significant economic burden on the health service (Godfrey et al., 2002; 25 Behnke et al., 1997; Chiu et al., 1990; Joyce et al., 1995; Norton et al., 1996; 26 Phibbs et al., 1991; US General Accounting Office, 1990). A strong assumption 27 of the model, with respect to additional healthcare and criminal justice costs, 28 was that users did not incur any such costs in periods during which they were 29 found to be abstinent from cocaine and illicit opiates, even when the periods 30 of abstinence were short, for example 1–2 weeks. 31 32 Despite the limitations of the analysis, there was little variation in the 33 components utilised in the model and the results were therefore generally 34 robust, as demonstrated in a sensitivity analysis. Overall, the results of the 35 analysis indicate that contingency management is a cost-effective option for 36 users of cocaine and illicit opiates undergoing methadone maintenance 37 treatment, especially when the wider economic, social and public health 38 consequences of drug misuse are considered.

39 8.4.5 Implementation studies of contingency management 40 Evidence for the efficacy of contingency management in the treatment of drug 41 miscue has been available for over a decade (Petry, 2001) but it has not seen 42 widespread implementation in the NHS or even in the United States where 43 much of the efficacy research on contingency management has been 44 conducted. In this respect contingency management is not different from 45 many other non-pharmacological treatments where uptake of the

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1 interventions can be limited even after the publications of guidance 2 specifically designed to promote their uptake (Sheldon et al, 2004; Grimshaw 3 et al, 2004). Despite these similarities contingency management appears to 4 raise particular concerns about its implementation in routine care (Petry, 5 2001). 6 7 The concerns raised relate to a number of areas and include the attitudes of 8 staff and senior managers, the particularities of the RCTs and the participants 9 recruited to such studies, the costs associated with its implementation, the 10 reluctance of service users to willingly participate in a contingency 11 management programme and the cultural difference between the health care 12 system of the United States and other, particularly publicly funded health 13 care systems such as exist in the UK. All of these concerns are seen as 14 potential barriers to effective implementation and will be discussed in light of 15 evidence from implementation studies identified. 16 17 A number of studies (Willinberg et al, 2004; McGovern et al, 2004; Kellogg et 18 al 2005; Kirby et al, 2006; Ritter and Cameron, 2006) have looked at staff 19 attitudes to contingency management have reported a generally positive 20 attitude by the majority surveyed. Four of the studies took place in the United 21 States, with one in Australia (Ritter and Cameron, 2006) and the majority of 22 the participants were employed in publicly funded services such as the 23 Veterans Administration substance misuse services. A number of studies have 24 used a questionnaire, the Provider Survey of Incentives (Kirby et al., 2006) to 25 facilitate comparisons between services. In one such comparison, between the 26 US and Australian services, US services showed more positive responses but a 27 significant number of the Australian respondents were neutral rather than 28 negative to contingency management (Ritter and Cameron, 2006). More senior 29 staff such as senior clinicians and programme mangers tended to have more 30 positive attitudes to contingency management, where as other staff favoured 31 the use of other psychosocial interventions such as cognitive behavioural 32 therapy or motivational enhancement (McGovern et al, 2004). The specific 33 objections raised by staff are well summarised by Kirby et al (2006) and 34 mirror findings from the other studies. They included: the possibility that 35 incentive programs are viewed by treatment providers as being too costly and 36 labour intensive; too difficult to implement, and a poor fit with what 37 clinicians are already doing; and that treatment providers are not adequately 38 trained to administer contingency management. 39 40 A number of studies have reported on the implementation of contingency 41 management which focus on organisational responses and service user 42 outcomes. In the most comprehensive report Kellogg et al (2005), describe the 43 introduction of contingency management into a large publicly funded 44 substance misuse services in New York. The services involved in the 45 implementation programme included; eight methadone treatment 46 programmes, 19 outpatient chemical dependency treatment programmes,

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1 eight inpatient detoxification units, two halfway houses, a residential 2 programme run in partnership with a community-based provider, four 3 hospital intervention and referral services, and an intensive case management 4 programme. The programme described by Kellogg et al, sought to address the 5 concerns commonly raised and provided important information both on the 6 necessary changes required from staff, the training and support programmes 7 required to support its implementation and the responses of services users. 8 Unsurprisingly key to successful implementation was the endorsement of the 9 programme directors and a willingness of the directors and implementation 10 team to engage with the concerns of staff. This also needed to be supported 11 with a full educational and training programme which provided clear 12 direction for staff many of whom were unfamiliar with the basic principles of 13 contingency management. A crucial element seemed to be that staff 14 recognised contingency management as an intervention aimed at changing 15 key behaviours and not simply rewarding people for generally being well 16 behaved. Service user based quantitative outcomes in this study whilst 17 positive, were very limited and were concerned only with increased 18 participation, for example in vocational rehabilitation programmes. However, 19 a series of interviews and discussions with staff and service users suggested 20 that contingency management had : increased service user motivation for 21 treatment; facilitated therapeutic progress; improved the attitude and morale 22 of staff; and promoted the development of more positive relationships not 23 only between service users and staff, but also amongst staff members (Kellogg 24 et al., 2005). In this study contingency management shifted from being an 25 intervention which was viewed as being potentially problematic to integrate 26 with other interventions to becoming the main focus of interventions with the 27 programme’s users. 28 29 Three other studies report some service user based outcomes, the first, Petry 30 et al. (2001), is a small case series which describe the successful use of 31 contingency management in individuals with a range of substance misuse 32 and psychiatric problems. The second study, by Lawental and Eshkol (2006) 33 describes the impact of the implementation of contingency management in a 34 methadone maintenance programme in a drug treatment unit in Haifa, Israel. 35 This study described the outcomes for two groups before implementation (n = 36 35) and after implementation (n = 41) of contingency management and 37 reported an improvement of 36% in clean urine tests (chi sq. = 11.08, p<0.01) 38 following the implementation. No other adjustments were made to the 39 delivery of the unit’s treatment programme other than the introduction of 40 contingency management. The final study by Shoptaw et al. (2006) looked at 41 the impact of contingency management on the reduced use of 42 metamphetemine among gay and bisexual men in specialist HIV services in 43 San Francisco. The intention of the programme was to reduce 44 metamphetemine use and thereby also reduce risky sexual practices in a 45 group with a high HIV prevalence. The group studied (n = 143) had a high 46 rate of metamphetemine use with 42.7% reporting daily use and a further

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1 43.4% at least weekly use, 77.6 % of the sample were HIV positive with large 2 numbers engaging in unprotected sex (for example, 70.6% reported 3 unprotected anal sex in the last month). The programme reported good 4 recruitment rates, reduced drug use comparable with results in trials with 5 similar populations (Shoptaw et al., 2005) and acceptability by service users. 6 However, retention rates (30% at 12 weeks) were lower than in comparable 7 programmes for non-HIV populations which were possibly attributed to the 8 lower reinforcement values offered. The costs were considered by the authors 9 to be ‘modest’ and the implementation programme was continued following 10 the completion of the evaluation.

11 8.4.6 Clinical summary 12 Contingency management — For people in methadone maintenance treatment 13 programmes who misuse illicit drugs, contingency management leads to 14 clinically significant reductions in the illicit drug use (including both opiates 15 and cocaine), during treatment and at follow-up. In contrast, the evidence for 16 the efficacy of contingency management for people maintained on 17 buprenorphine was weak, with no effects comparable to those obtained with 18 contingency management and methadone maintenance treatment. This may 19 reflect differences in the population in the trials, comparator groups or 20 possibly the impact of the differential effects of the methadone and 21 buprenorphine on the reward system under-pinning contingency 22 management. 23 24 Family or couples based interventions — For individuals who have contact 25 with a family member or carer and who are in receipt of methadone 26 maintenance treatment, the addition of behavioural couples therapy or 27 behaviourally focused family-based interventions can lead to reduction in the 28 use of illicit opiates or cocaine. 29 30 Short-term psychodynamic therapy — Short-term psychodynamic therapy 31 did not appear to reduce illicit opiate use but in one trial there was evidence 32 of reduced stimulant use during treatment. 33 34 Cognitive behavioural therapy — Standard and relapse-prevention cognitive 35 behavioural therapy did not show evidence of a benefit in the methadone 36 maintenance treatment trials on opiate use but there was very limited 37 evidence of benefits on stimulant use. Additionally, in a direct comparison 38 between standard cognitive behavioural therapy and psychodynamic 39 therapy, there were no statistically significant differences between the two 40 treatments either for opiate or stimulant use. 41 42 In summary, the use of contingency management in combination with 43 methadone maintenance treatment, but not with buprenorphine, shows 44 significant benefit in the reduction of illicit opiate and stimulant use. Similar 45 results are obtained for behaviourally-orientated family interventions, albeit

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1 from a more limited evidence base. There is little evidence to support the use 2 of short-term psychodynamic psychotherapy or standard or relapse- 3 prevention cognitive behavioural therapy in methadone treatment 4 programmes. A small number of studies describe some of the barriers to 5 successful implementation of contingency management and there are limited 6 but encouraging results from these studies suggesting that it may be possible 7 to implement contingency management programmes outside of clinical trials 8 and in countries other than the United States. 9

10 8.4.7 Clinical practice recommendations

11 8.4.7.1 Drug misuse services should introduce contingency 12 management programmes to reduce illicit drug use and/or promote 13 engagement in services for people undergoing methadone 14 maintenance treatment.

15 8.4.7.2 Contingency management aimed at reducing illicit drug use 16 for people undergoing methadone maintenance treatment or for 17 people who primarily misuse stimulants should adhere to the 18 following principles. 19 • The scheme should provide incentives (usually privileges or 20 vouchers) contingent on each presentation of a drug-negative 21 screen (for example, free from cocaine or non-prescribed 22 opiates). 23 • The frequency of screening should be set at three tests per 24 week for the first 3 weeks, two tests per week for the next 3 25 weeks and once weekly thereafter until stability is achieved 26 • If vouchers are used they should have monetary values in the 27 region of £5 and increase in value with each additional, 28 continuous period of abstinence 29 • Urinalysis is the preferred method of testing but consideration 30 may be given to the use of oral fluids.

31 8.4.7.3 When delivering contingency management programmes 32 healthcare professionals should ensure that: 33 • the target goal is agreed in collaboration with the service user 34 • the service user fully understands the relationship between 35 the desired behaviour change and the incentive schedule 36 • incentives are individualised, with choice available so that the 37 incentive is perceived as such by the service user (not just the 38 healthcare professional) and supports a healthy/drug free 39 lifestyle.

40 8.4.7.4 Family or couples-based interventions should be considered 41 for people who are in close contact with a partner, family member or

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1 carer and continue to use illicit drugs when in opiate agonist 2 maintenance treatment. These interventions should: 3 • focus on the service user’s drug misuse 4 • consist of at least 12 weekly sessions 5 • be based on cognitive behavioural principles.

6 8.4.7.5 All interventions for people who misuse drugs should be 7 delivered by trained staff who are competent in delivering the 8 intervention and are in receipt of appropriate supervision.

9 8.4.8 Research recommendation – contingency management

10 Implementation of contingency management

11 8.4.8.1 For people who misuse drugs, what methods of 12 implementing contingency management (including delivering and 13 ceasing rewards) and in what settings (including legally mandated, 14 community-based and residential), compared with one another and 15 standard care, are associated with longer periods of continued 16 abstinence, reduced drug use and maintenance of 17 abstinence/reduction of drug use at follow-up? 18 Why this is important 19 20 Although the efficacy of contingency management for drug misuse has been 21 extensively investigated, there is a lack of large-scale and well-conducted 22 implementation studies. The implementation of contingency management 23 programmes in the UK would be aided by research assessing specific 24 components of the programme.

25 Testing within contingency management programmes

26 8.4.8.2 For people who misuse drugs and are receiving contingency 27 management, are urinalysis, sweat and oral fluid analyses alone and 28 in comparison with one another sensitive, specific, cost-effective and 29 acceptable to service users? 30 Why this is important 31 32 There is a lack of data comparing sensitivity and specificity, cost-effectiveness 33 and acceptability to service users of these methods of identification of drug 34 use. Identifying drug use during treatment is an important aspect of 35 contingency management; therefore assessing which method(s) are more 36 effective on the above outcomes is an important issue for health and social 37 care settings intending to implement contingency management programmes. 38

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1 8.5 Psychological interventions in combination with naltrexone 2 maintenance treatment

3 8.5.1 Introduction 4 Naltrexone is an opiate antagonist which blocks the euphoric and other effects 5 of opiates, and therefore eliminates the positive rewards associated with 6 opiate use. A recent health technology appraisal conducted by NICE (2006) 7 concluded that naltrexone may have some limited benefit in helping those 8 who have been detoxified from opiates in remaining abstinent, although very 9 limited evidence also suggests naltrexone to be more effective in individuals 10 who are highly motivated. The HTA also recommended that people who are 11 prescribed naltrexone engage in psychosocial interventions, such as 12 counselling and self-help groups. However, the presented evidence only 13 suggests that contingency programmes, providing incentives for individuals 14 to remain abstinent, have any positive impact on naltrexone compliance and 15 other outcomes. A central question is whether the wider evidence base for 16 psychosocial interventions substantiates the HTA’s recommendation. 17 18 Naltrexone is not widely used in the UK, accounting for only 11,000 to 14,000 19 prescriptions per annum, not all of which would be for managing opiate 20 dependence (NICE, 2006). Where it is prescribed, it is not evident whether this 21 is done as part of a comprehensive package of care that includes 22 psychological intervention and general support. 23

24 8.5.2 Databases searched and inclusion/exclusion criteria 25 Information about the databases searched and the inclusion/ exclusion 26 criteria used for this section of the guideline is in Table 23. 27 Table 23: Databases searched and inclusion/exclusion criteria for clinical 28 effectiveness of psychological interventions in combination with naltrexone 29 maintenance treatment

Electronic databases MEDLINE, EMBASE, PsycINFO, HMIC, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who are undergoing naltrexone maintenance treatment for opiate dependence Interventions Opiate antagonist treatment: naltrexone Psychological interventions: CM, CBT, family-based interventions, psychodynamic interventions Outcomes Abstinence: point abstinence, duration of abstinence Illicit drug use: frequency of using illicit drugs over a period of time Compliance with naltrexone: number of doses or days taken

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1 8.5.3 Studies considered13 2 The review team conducted a new systematic search for RCTs that assessed 3 the efficacy of contingency management, interpersonal therapy, cognitive 4 behavioural therapy, behavioural couples therapy, psychodynamic and 5 family-based interventions (see Table 24). 6 7 In the review of naltrexone in combination with contingency management, 8 three trials (CARROLL2001B; CARROLL2002; PRESTON1999) met the 9 eligibility criteria, providing data on 171 participants. All trials were 10 published in peer-reviewed journals. 11 12 For naltrexone in combination with relapse-prevention cognitive behavioural 13 therapy, two trials (RAWSON2001; TUCKER2004B) met the guideline 14 eligibility criteria, providing data on 256 participants. All trials were 15 published in peer-reviewed journals. 16 17 For naltrexone in combination with family-based interventions, two trials 18 (CARROLL2001B; FALS-STEWART2003) met the eligibility criteria, providing 19 data on 216 participants. All trials were published in peer-reviewed journals. 20 21 In addition, two studies were excluded from the analysis. The most common 22 reason for exclusion was poor study quality (further information about both 23 included and excluded studies can be found in Appendix 14).

24 8.5.4 Summary evidence profiles for psychological interventions in 25 combination with pharmacological maintenance treatment

13 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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Table 24: Study information table for trials of psychological interventions in combination with naltrexone versus control Naltrexone + CM versus Naltrexone + CBT (RP) Naltrexone + family-based naltrexone + standard care versus naltrexone + interventions versus standard care naltrexone + standard care Total no. of 3 RCTs 2 RCTs 2 RCTs trials (total (N = 172) (N = 253) (N = 216) no. of participants) Study ID CARROLL2001B RAWSON2001 CARROLL2001B CARROLL2002 TUCKER2004B FALS-STEWART2003 PRESTON1999 Problem drug Opiate dependence Opiate dependence Opiate dependence or diagnosis Treatment 12 weeks 12 weeks (TUCKER2004B) 12 weeks length (CARROLL2001B, 52 weeks (RAWSON2001) (CARROLL2001B) CARROLL2002, 24 weeks (FALS- PRESTON1999) STEWART2003) Length of 3 to 6 months 3 to 12 months 12 months follow-up Age (years) 32 to 33 30 to 33 33 to 34 Overall Moderate Moderate Moderate quality of evidence Compliance Days/doses used: SMD - Days/doses used: SMD - Days/doses used: SMD - with 0.69 (-1.32 to -0.06) 0.74 (-1.19 to -0.29) 0.46 (-0.73 to -0.19) naltrexone K = 3, N = 172 K = 1, N = 81 K = 2, N = 216 Durations of Cocaine Continuous duration: Cocaine abstinence Longest duration: SMD - 3 weeks: RR 1.46 (1.02 to Longest duration: SMD - 0.32 (-0.67 to 0.03) 2.10) 0.43 (-0.84 to -0.01) K = 2, N = 133 K = 1, N = 92 8 weeks: RR 1.19 (0.68 to Proportion days abstinent: 2.09) Proportion days abstinent: SMD -0.32 (-0.77 to 0.12) K = 1, N = 81 SMD -0.41 (-0.76 to -0.05) K K = 1, N = 77 = 2, N = 133 Proportion opiate negative Opiates urines during treatment: Opiates Longest duration: SMD - SMD -0.66 (-1.11 to -0.22) Longest duration: SMD - 0.41 (-0.76 to -0.05) K = 2, K = 1, N = 81 0.45 (-0.86 to -0.03) N = 133 K = 1, N = 92

Proportion days abstinent: Proportion days abstinent: SMD -0.07 (-0.52 to 0.37) SMD -0.43 (-0.70 to -0.16 K = 1, N = 77 K = 2, N = 133 Point - Negative urine or self- - abstinence report: Endpoint: RR 1.13 (0.62 to 2.05) K = 1, N = 81 Illicit drug - Days heroin use in past - use month: Endpoint: SMD -0.16 (-0.58 to 0.26) K = 1, N = 88

3-month follow-up: SMD 0.13 (-0.30 to 0.56) K = 1, N = 84 Mortality - RR 0.98 (0.14 to 6.59) - K = 1, N = 81 1

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1 8.5.5 Clinical summary 2 Contingency management, behavioural couples therapy and family-based 3 interventions were all associated with significantly improved outcomes 4 during treatment, but there is very limited follow-up data in any of the six 5 trials and no evidence of long-term benefit. 6 7 There were mixed results for cognitive behavioural therapy. The trial with a 8 52-week duration appeared to be effective, however, a more recent 12-week 9 trial did not appear to effect drug use. 10 11 Given the recommendation in the NICE technology appraisal for a specific 12 psychosocial intervention to support the use of naltrexone (which currently 13 has a very low rate of uptake in the NHS) current evidence would suggest 14 that service user and clinician preference, and whether the service user is in 15 close contact with a partner or family member, should direct the choice of 16 contingency management, behavioural couples therapy and family-based 17 interventions.

18 8.5.6 Clinical practice recommendation 19 8.5.6.1 For people on naltrexone maintenance treatment to prevent 20 relapse to opiate dependence, healthcare professionals should 21 consider the use of the following psychosocial interventions:

22 • For all service users – contingency management 23 • For all people in contact with a partner, family member, or carer – 24 family or couples-based interventions. 25 26 These should be based on the same principles as those used for people 27 on methadone maintenance treatment.

28 8.6 Self-help groups 29 Introduction 30 There is a long tradition in North America and Europe of self-help groups for 31 people with substance misuse. Most of these offer a programme of recovery 32 known as the 12-steps, which has its origins in Alcoholics Anonymous. Self- 33 help groups especially relevant to drug users are Narcotics Anonymous (NA) 34 and Cocaine Anonymous (CA). There are other self-help groups available that 35 offer alternative philosophies and approaches, but these have not taken root 36 in the UK to the same extent as 12-step groups. There is open access to 37 groups; the only entry requirement is for individuals to acknowledge that 38 they have a drug problem. People may attend simply with a desire to become 39 abstinent; it is not a requirement to be drug-free at first attendance. 40 41 There have been few research studies into the acceptability of the 12-step 42 programme among British drug users; however, a series of studies conducted

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1 in London NHS inpatient detoxification services (for example, Harris et al., 2 2000; Best et al., 2001) have suggested that people who were drug dependent 3 reported more positive attitudes to NA/AA and to the 12-step programme 4 than those who were alcohol dependent and reported a greater intention to 5 attend after detoxification. 6 7 Current practice 8 Over the past 15 years, there has been a marked increase in availability of self- 9 help group meetings in the UK. In 2003, there were approximately 500 regular 10 NA group meetings nationwide; by 2006, this had risen to 800 11 (www.ukna.org). Many individuals will make use of self-help groups without 12 first having contact with statutory drug services, either self-referring or 13 attending following advice from a non-drug specialist such as a GP or other 14 member of the primary care team. 15 16 One of the limitations of the literature reviewed below is the lack of UK 17 studies, with the majority of studies on 12-step self-help groups conducted in 18 the US. However, the growth of NA in the UK suggests that there is some 19 acceptability of this resource among people who misuse drugs.

20 8.6.1 Definitions of interventions 21 Self-help groups 22 A group of people who misuse drugs meet regularly to provide help and 23 support for one another. The group is typically community-based, peer-led 24 and non-professional. 25 26 12-step self-help groups 27 A non-profit fellowship of people who meet regularly to help each other 28 remain abstinent. The core of the 12-step programme is a series of 12 steps 29 that include admitting to a drug problem, seeking help, self-appraisal, 30 confidential self-disclosure, making amends – when possible – where harm 31 has been done, achieving a spiritual awakening and supporting other drug 32 addicts who want to recover. 33

34 8.6.2 Databases searched and inclusion/exclusion criteria 35 Information about the databases searched and the inclusion/ exclusion 36 criteria used for this section of the guideline is in Table 25. 37 38 39 40

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1 Table 25: Databases searched and inclusion/exclusion criteria for clinical 2 effectiveness of self-help interventions

Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Observational studies Patient population People who misuse opiates, stimulants, cannabis, poly drugs Interventions Self-help 12-step SHGs Outcomes Abstinence: point abstinence , duration of abstinence Illicit drug use: frequency of using illicit drugs over a period of time

3 4 The review team conducted a systematic search for RCTs and observational 5 studies that assessed the efficacy of 12-step self-help groups. Seven studies 6 met the inclusion eligibility criteria set by the GDG. Two were RCTs 7 (MCAULIFFE1990; TIMKO2006), two were cohort studies (MOOS1999; 8 ETHERIDGE1999), one was a prospective longitudinal study 9 (FIORENTINE2000), one was a case series (TOMBOUROU2002) and one was 10 a sub-analysis of self-help group participation in all groups of an RCT 11 (WEISS2005). All studies were published in peer-reviewed journals. 12 13 In addition, 16 studies were excluded from the analyses. The most common 14 reason for exclusion was diagnosis of comorbid psychosis. 15 16 Benefits of attendance at self-help groups 17 18 The majority of studies on self-help groups have looked at 12-step-based 19 groups. Various studies show that 12-step involvement has a positive impact 20 on outcomes. For example, Weiss and colleagues (2005) show that, while 21 simple attendance did not predict drug use, active participation in self-help 22 groups did predict lower cocaine use in the following month and increasing 23 levels of participation produced a significant incremental benefit. Similar 24 associations between NA attendance and improved drug-use outcomes are 25 reported by Fiorentine and Hillhouse (2000). 417 participants commencing 26 outpatient substance misuse treatment completed an intake interview and 8 27 months later completed a follow-up interview, in order to determine the 28 relationship between drug treatment participation and 12-step involvement. 29 Overall findings illustrate that individuals who regularly attended 12-step 30 programmes prior to treatment had significantly higher rates of successful 31 treatment completion. Fiorentine and Hillhouse also demonstrate an additive 32 effect of engaging in treatment and a 12-step self-help groups at the same 33 time, as this results in significantly better treatment outcomes when compared 34 to drug treatment or 12-step self-help group participation alone. In Australia, 35 Tombourou and colleagues (2002) conducted interviews with 91 new 36 members entering NA self-help groups. At baseline, participants filled in 37 questionnaires regarding sociodemographic status and attendance levels at 38 12-step self-help groups in the year prior to the first interview. At 12-month

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1 follow-up, participants completed a second interview detailing levels of 2 involvement, highest step completed and levels of weekly attendance at the 3 self-help groups. Self-report measures indicated that higher and more stable 4 levels of NA involvement were associated with less marijuana and hazardous 5 alcohol use. 6 7 McAuliffe and colleagues (1990) conducted an RCT comparing a recovery 8 training and self-help programme with a control condition. The recovery 9 training and self-help group received a combined programme of 10 professionally led recovery skills workshops and weekly self-help group 11 meetings (not 12-step). They showed improved drug-use outcomes at 6 and 12 12 months in both a US and a Hong Kong sample. This may indicate that non 13 -12- step self-help groups are also beneficial in reducing relapse. 14 15 There is consistent evidence that 12-step attendance mediates better substance 16 misuse outcomes. However, it should be noted that in most studies reviewed 17 above self-help groups attendance was assessed alongside other treatment 18 programmes. Although there are clear associations between self-help group 19 attendance and drug-use outcomes, the impact of self-help groups outside of 20 intensive treatment programmes has not been assessed in enough detail. 21 22 Facilitating self-help group affiliation 23 A variety of studies have assessed interventions that encourage self-help 24 group affiliation. These interventions range from ‘intensive referral’, 25 providing advice, information and a personal contact (Timko et al., 2006), to 26 residential programmes with a strong 12-step focus. 27 28 A large-scale prospective cohort study (n = 3,018) conducted by Moos and 29 colleagues (1999) revealed that people receiving 12-step-based treatment for 30 drug and/or alcohol misuse had superior abstinence outcomes compared to 31 those in cognitive behavioural therapy or eclectic (based on a combination of 32 12-step and cognitive behavioural therapy principles) treatment groups. 33 Humphreys and colleagues (1999) sought to further investigate the 34 relationship between post-treatment self-help group participation and 35 abstinence. They suggest that the level of participation in self-help groups 36 may mediate the relationship between self-help group involvement and 37 abstinence; that is, those receiving 12-step-based treatment programmes were 38 more highly involved in self-help groups than those in either cognitive 39 behavioural therapy or eclectic treatment programmes; thus, increased levels 40 of participation may have facilitated positive outcomes. 41 42 Timko and colleagues (2006) investigated the effects of intensive versus 43 standard referral to self-help groups (based on the 12-step model), in order to 44 determine which method increased self-help group attendance over a 6- 45 month period. Participants commencing substance-use outpatient treatment 46 were randomly assigned to either group; those in the standard referral group

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1 received a timetable of local meetings. Participants in the intensive referral 2 group received the same material as those in the standard group, with the 3 addition of an information pack detailing various aspects of 12-step meetings 4 and a more intensive discussion of the benefits, and potential concerns, of 5 attending 12-step meetings. They were required to keep a record of self-help 6 group meetings they attended and give brief descriptions of their personal 7 reactions to and thoughts regarding the meeting. Counsellors also arranged 8 for the participants to meet with a self-help group volunteer who would 9 accompany them to their first meeting. At 6 months’ follow-up, the intensive 10 referral group showed greater attendance of and participation in self-help 11 groups compared with those in the standard referral group. Furthermore, 12 those in the intensive referral group showed greater reduction in alcohol and 13 drug use and were more likely to be abstinent compared with those in the 14 standard referral group. 15 16 Ouimette and colleagues (1998) showed that there was a synergistic effect 17 between outpatient aftercare provision and 12-step self-help group 18 participation following treatment. Service users who participated in both did 19 better than those who only participated in one or the other. Those who did 20 neither had the poorest outcomes. Once again, this study showed that 21 increased frequency of attendance and increased involvement in 12-step 22 activities enhanced outcomes. 23 24 Clinical Summary 25 In summary, there have been several studies assessing the use of self-help 26 groups for people who misuse drugs. The majority of studies have been 27 conducted on 12-step programmes. There is limited but consistent evidence 28 from these studies that 12-step attendance is associated with abstinence from 29 illicit drugs and alcohol, and fewer drug and alcohol problems. Furthermore, 30 involvement in such programmes can be improved by interventions from 31 healthcare professionals to encourage regular attendance and active 32 participation with such groups. 33

34 8.6.3 Clinical practice recommendations

35 8.6.3.1 Healthcare professionals should routinely provide 36 information about self-help groups for people who misuse drugs. The 37 most established of such groups are those based on 12-step principles, 38 for example Narcotics Anonymous and Cocaine Anonymous.

39 8.6.3.2 If a person who misuses drugs has expressed an interest in 40 attending 12-step self-help groups, healthcare professionals should 41 consider facilitating the person’s initial contact with the groups. 42

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1 8.7 Co-ordination of care and case management

2 8.7.1 Introduction 3 This section focuses on the evidence for the use of psychological interventions 4 as part of broader packages of care, in particular case management. Case 5 management is a strategy to improve the co-ordination of care for people who 6 misuse drugs. It was devised for people with complex and multiple needs. An 7 individual worker is responsible for the co-ordination and, where necessary, 8 provision of care for service users. Contact with the case manager is usually 9 expected to be on a regular ongoing basis. Case management originated in the 10 mental health field and since the early 1980s it has been used in substance 11 misuse services, mostly in the US but also in some European countries (in 12 particular the Netherlands and Belgium). 13 14 In UK practice, case management has not been applied systematically in the 15 same way as it has in the US and other European countries. The closest to case 16 management in the UK is care planning and care co-ordination approach, 17 which have recently been the focus of much attention from the NTA, who 18 established this as an important area for development in UK services. Care 19 planning and care co-ordination have also been the subject of the recent 20 Health Commission and NTA review of services across the UK, establishing 21 these as important areas for development in UK services (NTA, 2006a). One of 22 the conclusions of this review is that there is wide variation in procedures 23 across the country.

24 8.7.2 Definitions of interventions

25 Case management 26 There is no unified definition of case management, and programmes vary 27 depending on clinical populations and treatment systems. The guiding 28 principle, consistent with a long-term view of drug problems, is that of co- 29 ordinating episodes of care both over time and across health and social care 30 systems. In practice, a case manager works with the service user in order to 31 enrol the service user in the required services and co-ordinate the various 32 services required for the complex array of problems.

33 Intensive referral

34 This intervention aims to engage service users into treatment via an initial 35 needs assessment and referral session, but does not provide the element of 36 ongoing contact that is considered here as characteristic of case management. 37 38 Standard referral 39 40 Service user is provided with a list of contact details and they are expected to 41 make their own appointments.

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1 8.7.3 Databases searched and inclusion/exclusion criteria 2 Information about the databases searched and the inclusion/ exclusion 3 criteria used for this section of the guideline is in Table 26. 4 5 Table 26: Databases searched and inclusion/exclusion criteria for clinical 6 effectiveness of case management

Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who misuse opiates, stimulants, cannabis, poly drugs Interventions Case management, intensive referral, care coordination Outcomes Abstinence: point abstinence, duration of abstinence Drug use: frequency of using illicit drugs over a period of time 7 8 The review team conducted a new systematic search for RCTs that assessed 9 the efficacy of case management (see Table 27). For trials of intensive referral 10 versus standard referral, two RCTs met the eligibility criteria, providing data 11 on 286 participants. For trials of case management with ongoing contact 12 versus standard care, eight RCTs met the eligibility criteria providing data on 13 2,623 participants. 14 15 All trials were published in peer-reviewed journals. In addition, 5 studies 16 were excluded from the analysis. The most common reason for exclusion was 17 not providing required outcomes (further information about both included 18 and excluded studies can be found in Appendix 14). 19

20 8.7.4 Case management 21 Table 27: Study information table for trials of case management for people who 22 misuse drugs Intensive referral versus standard care Case management (with ongoing for people not in formal drug contact) versus standard care for treatment people not in formal drug treatment Total no. of 2 RCTs 8 RCTs trials (total no. (N = 286) (N = 2,623) of participants) Study ID STRATHDEE2006 COVIELLO2006 ZANIS1996 MARTIN1993 MEJTA1997 MORGENSTERN2006 NEEDELS2005: Study 1 NEEDELS2005: Study 2 SALEH2002 SORENSEN2005 Problem drug IDU: STRATHDEE2006 (100%) Any drug misuse in past 6 months: or diagnosis NEEDELS2005 (87%) Opiate dependence (seeking MMT): STRATHDEE2006 (100%), ZANIS1996 History of drug use associated with (100%) HIV risk: MARTIN1993 (100%)

Any substance dependence (DSM-IV):

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MORGENSTERN2006 (100%; 33% primarily alcohol)

Seeking residential substance misuse treatment: SALEH2002 (100%)

Opiate dependence: COVIELLO2006 (100%), MEJTA1997 (100%), SORENSEN2005 (100%) Treatment 1 week: STRATHDEE2006 6 weeks: COVIELLO2006 length 2 weeks: ZANIS1996 6 months: MARTIN1993, SORENSEN2005 12 months: SALEH2002 15 months: MORGENSTERN2006 36 months: MEJTA1997 Length of Up to 2 weeks Up to 3 years follow-up Age (years) 41 to 42 17 to 45

1 2 3 Table 28: Summary of evidence table for trials of case management for people who misuse drugs Intensive referral versus standard care Case management versus standard for people not in formal drug care for people not in formal drug treatment treatment Total no. of 2 RCTs 8 RCTs trials (total no. (N = 286) (N = 2,623) of participants) Study ID STRATHDEE2006 COVIELLO2006 ZANIS1996 MARTIN1993 MEJTA1997 MORGENSTERN2006 NEEDELS2005: Study 1 NEEDELS2005: Study 2 SALEH2002 SORENSEN2005 Overall quality Moderate Moderate of evidence Durations of - Drug-free days per month: SMD -0.13 abstinence (-0.47 to 0.20) K = 1, N = 140 Point - Cannabis: RR 1.14 (0.97 to 1.35) abstinence at K = 3, N = 1,538 follow-up Cocaine: RR 1.26 (0.81 to 1.98) K = 3, N = 1,538

Opiates: RR 1.34 (0.63 to 2.87) K = 2, N = 192

All drugs: RR 1.16 (0.59 to 2.31) K = 2, N = 565 Initiation of Started any treatment: RR 2.92 (0.52 to Started any treatment: RR 1.34 (1.04 to treatment 16.35) 1.72) K = 2, N = 286 K = 4, N = 2,028

Time taken to enter treatment: SMD - 1.63 (-1.88 to -1.37) K = 1, N = 316

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Retention in - In treatment at follow-up: RR 1.60 treatment (0.90 to 2.86) K = 3, N = 1,602

Completed at least one outpatient programme: RR 1.92 (1.35 to 2.72), K = 1, N = 302

Retained in any treatment for at least 3 months: RR 2.29 (1.55 to 3.39) K = 1, N = 302

Time retained in treatment: SMD -0.93 (-1.16 to -0.70), K = 1, N = 316 RR >1 favours intervention, negative SMD values favour intervention

1 8.7.5 Clinical summary 2 One of the difficulties when interpreting this evidence is the variation in the 3 sample populations, as well as what constitutes ‘case management’ in 4 different studies. 5 6 Bearing in mind these sources of variation, overall, the evidence available 7 consistently suggests that both intensive referral and case management, 8 whether limited to a ‘brief’ care planning session, or initial care planning with 9 ongoing contact, is effective at engaging service users in treatment at different 10 stages of the treatment process. In terms of effects on illicit drug use, however, 11 the evidence is mixed, with the overall suggestion of the meta-analysis that 12 there is no improvement in outcomes compared to standard care. 13 14 While all the studies reviewed are US-based and hence interpretation should 15 consider the cultural and health system differences already outlined, it should 16 be noted that a remarkably similar picture is presented in mainstream mental 17 health contexts in the UK and US, in that case management tends to improve 18 treatment engagement but does not itself necessarily make a difference to 19 outcomes (for example, for schizophrenia; NICE, 2003). The current evidence 20 implies that for people who misuse drugs, effective, structured psychological 21 interventions must be delivered in addition to standard care planning in 22 order to achieve improved outcomes. 23

24 8.7.6 Clinical practice recommendation

25 8.7.6.1 Healthcare professionals should be aware that service users 26 are at high risk of losing contact with services at points of transition 27 between services and should ensure that clear and agreed plans are in 28 place to ensure effective transfer through services. This could be 29 achieved through the use of agreed care plans, identified 30 professionals and appropriate assessment systems. 31

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1 8.8 Multi-modal care programmes

2 8.8.1 Introduction 3 Multi-modal care programmes for the purpose of this review are defined as 4 including a combination of therapy activities delivered in intensive schedules 5 of 10 hours per week or more. Content of these programmes varies but would 6 usually include education, daily living skills and other psychologically based 7 interventions (for example, cognitive behavioural therapy, relapse prevention 8 and reinforcement-based approaches), mostly delivered in group format. 9 Such programmes are not common in generic drug treatment services in the 10 UK?, although they are available in some areas. They are more commonly 11 used within drug services linked to the criminal justice system as a way of 12 providing more intensive programmes for those referred. The current use of 13 these interventions in the UK is limited and their distribution is not well 14 understood. 15

16 8.8.2 Definitions 17 Standard outpatient treatment 18 Treatment occurs in regularly scheduled sessions typically totalling 1–2 hours 19 per week. Examples include weekly or twice-weekly individual therapy, 20 weekly group therapy or a combination of the two. 21 22 Extended outpatient treatment 23 Outpatient treatment as above, but with up to 9 contact hours per week, 24 typically involving additional groupwork (group therapy, educational groups 25 and/or self-help groups). 26 27 Intensive outpatient treatment 28 Healthcare professionals provide several treatment components to service 29 users. Treatment consists of regularly scheduled sessions within a structured 30 programme, with a minimum of 9 contact hours per week (American Society 31 of Addiction Medicine, 2001). 32

33 Intensive outpatient treatment with reinforcement-based treatment 34 Intensive outpatient treatment as above, but with additional benefits (such as 35 the right to undertake vocational training and/or paid work) contingent on 36 providing a drug-free urine sample. 37 38 39 40 Structured day treatment

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1 Structured day treatment provides intensive community-based support, 2 treatment and rehabilitation. Clear programmes of defined activities should 3 be offered for a fixed period of time with specified attendance criteria, usually 4 4–5 days (20 hours total) per week (NTA, 2002). 5

6 8.8.3 Databases searched and inclusion/exclusion criteria 7 Information about the databases searched and the inclusion/ exclusion 8 criteria used for this section of the guideline is in Table 29. 9 10 Table 29: Databases searched and inclusion/exclusion criteria for clinical 11 effectiveness of multi-modal care programmes

Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Patient population People who misuse opiates, stimulants, cannabis, poly drugs Interventions Intensive outpatient treatment, reinforcement-based intensive and extended outpatient treatment, day treatment Outcomes Abstinence: point abstinence, duration of abstinence Illicit drug use: frequency of using illicit drugs over a period of time 12 13 The review team conducted a new systematic search for RCTs that assessed 14 the efficacy of multi-modal care programmes (see Table 30). 15 16 In the review of intensive outpatient treatment, 4 trials met the eligibility 17 criteria providing data on 717 participants. All trials were published in peer- 18 review journals. 19 20 In the review of day treatment, 2 trials met the guideline eligibility criteria 21 providing data on 370 participants. All trials were published in peer-reviewed 22 journals. 23 24 In the review of intensive outpatient treatment with reinforcement-based 25 therapy, three trials met the eligibility criteria providing data on 282 26 participants. Two trials were published in peer-reviewed journals and one 27 was in press. 28

29 8.8.4 Multi-modal treatment programmes 30 Table 30: Study information table for trials of intensive outpatient treatment, day 31 treatment and reinforcement-based therapy 32 Intensive outpatient Intensive outpatient Day treatment versus Intensive outpatient treatment versus treatment versus standard outpatient treatment with RBT standard outpatient extended outpatient treatment versus standard care treatment treatment Total no. of 3 RCTs 1 RCT 2 RCTs 3 RCTs trials (total (N = 623) (N = 94) (N = 370) (N = 282)

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no. of participants) Study ID MCLELLAN1993 COVIELLO2001 AVANTS1999 JONES2005 VOLPICELLI2000 MARLOWE2003 SILVERMAN2001 WEINSTEIN1997 SILVERMAN in press Problem drug Cocaine dependence Cocaine dependence Cocaine dependence Opiate dependence or diagnosis (DSM-III-R/IV): (DSM-III-R/IV): (DSM-III-R/IV): (MMT) VOLPICELLI2000 COVIELLO2001 MARLOWE2003 WEINSTEIN1997 Opiate dependence Opiate dependence (MMT): (MMT): AVANTS1999 MCLELLAN1993 Treatment 3 months: 1 month 3 months: 6 months length WEINSTEIN1997 AVANTS1999 6 months: 4 months: MCLELLAN1993 MARLOWE2003 12 months: VOLPICELLI2000 Length of Up to 9 months 7 months Up to 6 months 0 to 12 months follow-up Age (years) 32 to 41 40 34 to 36 38 to 45 1 2 Table 31: Summary evidence table for trials of intensive outpatient treatment, day 3 treatment and reinforcement-based therapy Intensive outpatient Intensive outpatient Day treatment versus Intensive outpatient treatment versus treatment versus standard outpatient treatment with RBT standard outpatient extended outpatient treatment versus standard care treatment treatment Total no. of 3 RCTs 1 RCT 2 RCTs 3 RCTs trials (total (N = 623) (N = 94) (N = 370) (N = 282) no. of participants) Study ID COVIELLO2001 COVIELLO2001 AVANTS1999 JONES2005 MCLELLAN1993 MARLOWE2003 SILVERMAN2001 VOLPICELLI2000 SILVERMAN in press WEINSTEIN1997 Overall Moderate Moderate Moderate Moderate quality of evidence Durations of Cocaine (secondary to - Maximum Cocaine abstinence MMT) consecutive cocaine- Proportion negative Continuous duration: negative urines: SMD urines: SMD -0.59 (- 8 weeks: RR 1.02 (0.81 0.14 (-0.30 to 0.59) 1.22 to 0.05) to 1.28) K = 1, N = 79 K = 1, N = 40

16 weeks: RR 1.28 Opiates (0.67 to 2.46) Proportion negative K = 1, N = 67 urines: SMD -0.63 (- 1.27 to 0.01) Opiates K = 1, N = 40 Continuous duration: 8 weeks: RR 0.91 (0.76 Cocaine and opiates to 1.10) Negative urines during treatment: RR 16 weeks: RR 1.94 2.48 (1.40 to 4.37) (0.97 to 3.87) K = 2, N = 170 K = 1, N =67 Proportion negative urines: SMD -0.66 (-

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1.30 to -0.02) K = 1, N = 40 Point - Cocaine Cocaine (secondary to Cocaine abstinence Endpoint: RR 0.96 MMT) Endpoint: RR 0.60 (0.63 to 1.45) Endpoint: RR 0.94 (0.25 to 1.43) (0.74 to 1.19) K = 1, N = 56 3-month follow-up: RR 1.04 (0.68 to 1.61) 6-month follow-up: Opiates K = 1, N = 96 RR 1.01 (0.72 to 1.41) Endpoint: RR 0.82 K = 1, N = 291 (0.51 to 1.32) K = 1, N = 56 Opiates Endpoint: RR 1.05 (0.83 to 1.32)

6-month follow-up: RR 0.89 (0.65 to 1.23) K = 1, N = 291

Cocaine and opiates Endpoint: RR 0.99 (0.73 to 1.34)

6-month follow-up: RR 0.90 (0.59 to 1.36) K = 1, N = 291 Drug use Cocaine - - - Self-reported days: Change from baseline: SMD 0.25 (- 2.38 to 2.88) K = 2, N = 219

1 8.8.5 Clinical summary 2 The evidence related to intensive outpatient treatments and day treatments 3 (defined respectively as at least 9 and 20 hours of group work per week) does 4 not support the notion that ‘more is better’ when comparing more intensive 5 treatments to standard outpatient treatment in relation to drug-use outcomes. 6 There is some evidence that reinforcement-based treatment can improve drug 7 use outcomes, though real-world application of this type of intervention may 8 be limited. It is important to note, however, that some of the standard practice 9 in the US appears to be better structured and more intensive than routine 10 outpatient UK practice. 11 12 8.9 Psychological interventions for carers

13 8.9.1 Introduction 14 There is an increasing recognition that drug misuse affects the entire family 15 and the communities in which these families live. For example, the Home 16 Office’s updated Drug Strategy (2002) includes targets on increasing access to 17 help, advice and counselling for parents, carers and families of people who 18 misuse drugs. Additionally, the NTA user satisfaction survey found that 25% 19 of respondents felt that staff did not offer families and carers enough support

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1 (Best et al., 2006). Therefore there is a need to assess if interventions for carers 2 are effective.

3 8.9.2 Definitions of interventions 4 5-Step intervention 5 The 5-Step intervention seeks to help families and carers in their own right, 6 independent of relatives who misuse drugs. It focuses on three key areas: 7 stress experienced by relatives, their coping responses and the social support 8 available to them. Step 1 consists of listening and reassuring the carer, Step 2 9 involves providing relevant information, Step 3 counselling about coping, 10 Step 4 counselling about social support and Step 5 discussion of the need for 11 other sources of specialist help. This intervention consists of up to five 12 sessions. 13 14 Community reinforcement and family training 15 Community reinforcement and family training is a manualised treatment 16 programme that includes training in domestic violence precautions, 17 motivational strategies, positive reinforcement training for carers and their 18 significant other, and communication training. However, the primary aim of 19 the treatment appears to be encouraging the person who misuses drugs to 20 enter treatment. This intervention consists of up to five sessions. 21 22 Self-help support groups 23 A group of families and carers of people who misuse drugs meet regularly to 24 provide help and support for one another. 25 26 27 Guided self-help 28 A professional offers a self-help manual (for example, based on the 5-Step 29 intervention) , provides a brief introduction to the main sections of the 30 manual and encourages the families and/or carers of people who misuse 31 drugs to work through it in their own time at home. 32

33 8.9.3 Databases searched and inclusion/exclusion criteria 34 Information about the databases searched and the inclusion/ exclusion 35 criteria used for this section of the guideline is in Table 23. 36 37 38 39 40

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1 Table 32: Databases searched and inclusion/exclusion criteria for clinical 2 effectiveness of psychological interventions for carers

Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to September 2006; table of contents September 2006 to November 2006 Study design RCT Patient population Families and/or carers of people who misuse drugs Interventions Psychosocial interventions: CRAFT, 5-Step Outcomes Reduced stress Increased coping 3 4 The review team conducted a new systematic search for RCTs that assessed 5 the efficacy and/or safety of community reinforcement and family training 6 and 5-Step for families/carers of people who misuse drugs (see Table 18). 7 8 For community reinforcement and family training, two trials (KIRBY1999; 9 MEYERS2002) met the eligibility criteria, providing data on 152 participants. 10 Both trials were published in peer-reviewed journals. 11 12 For the 5-Step intervention, one trial (COPELLOin press) met the eligibility 13 criteria, providing data on 114 participants. This trial is in press. 14 15 In addition, two trials were excluded from the analysis because they did not 16 have control groups. 17 18 Community reinforcement and family training 19 In both trials (Kirby et al., 1999; Meyers et al., 2002), community reinforcement 20 and family training was compared with 12-step-based self-help groups 21 (including 12-step facilitation) for carers. 22 23 The primary outcomes of these studies were to engage people who misuse 24 drugs and who had refused treatment into treatment, to reduce carers’ 25 reported problems (social/emotional, relationship and health-related) and 26 improve carers’ psychological functioning (mood and social adjustment). 27 Neither study found statistically significant differences between community 28 reinforcement and family training and 12-step-based self-help groups in 29 relation to carer problems and psychological functioning. Kirby and 30 colleagues (1999) found statistically significant changes from baseline for both 31 groups in relation to carer problems and psychological functioning. However, 32 Meyers and colleagues found no statistically significant differences (after 33 Bonferroni corrections) in changes from baseline at 12-month follow-up. 34 35 5-Step intervention 36 Copello and colleagues (in press) conducted a cluster-randomised trial (n = 37 143) comparing two intensities of a 5-Step intervention. Primary care 38 professionals were trained how to offer the 5-Step intervention and asked to

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1 recruit and deliver the intervention to family members of people who misuse 2 drugs and/or alcohol. All family members had experienced significant 3 distress and lived with the person who misuses drug or alcohol in the last 6 4 months. The majority of the sample were relatives of people who misuse 5 alcohol; only 41.2% were relatives of people who misuse drugs. The largest 6 proportions of family members included in the study were wives (43.1%) and 7 children (35.3%). 8 9 Each primary care professional was treated as a cluster and was randomised 10 to either the full intervention or guided self-help condition. The ‘full 11 intervention’ consisted of up to five sessions, while guided self-help 12 comprised of one session, with the primary care professional introducing the 13 self-help manual (based on the 5-Step model used in the full intervention) to 14 the family member and encouraging him or her to work through it in his or 15 her own time. 16 17 The two primary outcomes related to physical and psychological health 18 (symptom rating test), and coping (the coping questionnaire). No statistically 19 significant differences were found between the full intervention and the 20 guided self-help conditions for both physical and psychological symptoms 21 (WMD = 0.23; 95% CIs: -4.11 to 3.65), and coping (WMD = 0.12; 95% CIs: -5.42 22 to 5.19). 23

24 8.9.4 Clinical summary 25 For both community reinforcement and family training and 5-Step 26 interventions, there were no statistically significant differences found between 27 these more intensive interventions and self-help (that is, 12-step self-help 28 groups and guided self-help). It appears that self-help interventions are as 29 effective as more intensive psychological interventions in reducing stress and 30 improving psychological functioning for carers and families of people who 31 misuse drugs. 32

33 8.9.5 Clinical practice recommendations

34 8.9.5.1 Families and carers should be informed of, and if 35 appropriate offered, services to specifically address their needs. These 36 may include: 37 • the use of guided self-help 38 • support groups – for example, self-help groups solely for 39 families and carers, which are focused on addressing carers’ 40 needs.

41 8.9.5.2 If families and carers have been offered but not benefited 42 from guided self help and/or support groups and continue to have

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1 significant family problems, consideration should be given to 2 providing formal psychological interventions. This should: 3 • provide information and education about drug misuse 4 • help identify sources of drug misuse related stress 5 • exploring and promoting effective coping behaviours 6 • normally consist of at least five weekly sessions. 7

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1 9 Residential, prison and inpatient 2 care

3 9.1 Introduction 4 This chapter considers the extent to which the setting in which drug treatment 5 is provided can have an impact upon the effectiveness of that treatment. Drug 6 treatment in the UK currently takes place in a variety of settings. The settings 7 are considered in the tiered approach to treatment (NTA, 2006a). In this 8 system, Tier 1 treatment refers to the provision of generic services to drug 9 users (for example, provision of general medical services by general 10 practitioners). Tier 2 treatment refers to low-threshold drug-specific services 11 such as needle and syringe and distribution. Tier 3 treatment refers to more 12 structured interventions for drug misuse, which are delivered in the 13 community. Examples of such interventions include opiate maintenance 14 therapy and drug-misuse-specific psychological therapies. Tier 4 treatment 15 refers to structured interventions that take place in residential settings. 16 Examples include drug treatment in residential rehabilitation centres, prisons 17 or hospitals. The primary focus of this chapter is on Tier 4 but where possible 18 comparisons will be made with services provided at other tiers.

19 In the UK, most structured drug treatment takes place in the community 20 provided by statutory and independent sector services. Traditionally this has 21 been through people who misuse drugs volunteering to enter treatment. 22 However, there has recently been a rapid expansion in forms of so-called 23 ‘coerced’ treatment. Coerced treatment, also referred to as legally mandated 24 treatment, requires that the drug user enter into treatment as an alternative or 25 adjunct to criminal sanctions (Wild et al., 2002). Such treatment can either be 26 legally ordered by the court or through diversion away from the judicial 27 process, usually following arrest and charge of the person who misuses drugs 28 for drug related and other offences.

29 Despite the recent policy shift to diversion away from the courts, however, 30 many people who misuse drugs still serve prison sentences. Strang et al. 31 (2006) found that 55% of a random sample of male prisoners in England and 32 Wales had reported prior use of heroin, cocaine or amphetamine and that 59% 33 of these prisoners had reported using these drugs a month before current 34 imprisonment. Furthermore, over recent years, the prison population in the 35 UK has been rising suggesting the importance of drug-misuse treatment in 36 the prison setting. Such treatment is increasingly being offered following a 37 number of recent developments, including the phased transfer of 38 responsibilities for commissioning healthcare in publicly funded prisons from 39 the Home Office to the NHS (DH, 2006a). Whilst the mainstay of treatment 40 has traditionally been one of detoxification upon admission to prison, there

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1 has been a recent policy shift allowing increased access to opiate substitution 2 therapy and psychosocial interventions. 3 4 Despite the increasing recognition and availability of appropriate specialist 5 treatment in hospitals the primary method of planned alternative treatment to 6 community services remains residential rehabilitation. Best and colleagues 7 (2005) estimated that 6,090 places were made available for residential 8 rehabilitation in 2003/4. Day and colleagues (2005) also conducted a survey, 9 although the focus was predominantly on provision of inpatient 10 detoxification. There were an estimated 532 beds available for people who 11 misuse drugs in residential rehabilitation units in the UK with a total of 1,085 12 admissions per year. In contrast, there were estimated to be 356 specialist in- 13 patient beds available for problem drug users with an estimated 6,829 annual 14 admissions. In addition, there were an estimated 103 beds available in non- 15 specialist psychiatric or medical wards with a total of 2,077 admissions per 16 year. This resulted in a combined estimate of 10,711 annual admissions for 17 people who misuse drugs in inpatient or residential treatment (Day et al., 18 2005). 19

20 9.2 Inpatient settings 21 The key feature of an NHS inpatient unit for the treatment of drug misuse is 22 the provision of assessment, stabilisation and/or detoxification, and 23 psychosocial interventions with 24-hour cover from a multi-disciplinary team 24 (including psychiatrists, psychologists, nurses, occupational therapists, and so 25 on) with specialist training in drug misuse. Inpatient treatment is provided 26 for people with significant physical or psychiatric comorbidities who require 27 24-hour medical care (SCAN, 2006). 28 29 Day and colleagues (2005) survey of inpatient services in England found that 30 NHS inpatient units offered a mean of 18 hours per week of psychological 31 treatment predominantly delivered within groups. The most frequently 32 provided psychological treatments in this setting were relapse-prevention 33 cognitive behavioural therapy (82%), motivational enhancement (50%) and 34 standard cognitive behavioural therapy (43%). 35 36 The primary drug problems for most people admitted to inpatient units were 37 opiate misuse (35%), poly-drug misuse (12%), and drug and alcohol misuse 38 (10%). In contrast, only 3% of people admitted had a primary stimulant 39 problem (Day et al., 2005). 40 41 There are no studies that have specifically assessed the efficacy of inpatient 42 treatment in comparison with a meaningful control group. Although NTORS 43 included eight NHS inpatient units, outcomes from residential and inpatient 44 settings were combined, therefore specific conclusions on the efficacy of 45 inpatient treatment are not possible (Gossop et al., 2003).

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1 9.2.1 Clinical practice recommendation

2 9.2.1.1 Psychosocial interventions in inpatient settings should 3 consist of the same range of interventions offered in community 4 settings and would normally include contingency management, 5 family interventions, cognitive behavioural interventions and 6 encouragement to participate in self-help programmes. Treatment in 7 inpatient settings should normally be reserved for those who require 8 a high level of medical and nursing support because of comorbid 9 physical or severe psychiatric problems, and may be associated with a 10 detoxification programme.

11 9.3 Residential settings

12 9.3.1 Introduction 13 It has been accepted policy for some time that residential rehabilitation 14 centres comprise an important element in the integrated care pathways for 15 people who misuse drugs at different stages of their treatment, being of 16 particular importance in providing a possible pathway out of dependence 17 (DH, 2006b; NTA, 2006b). However, residential rehabilitation treatment has 18 not experienced the same growth as community-based treatment options, and 19 some have argued for the need to increase both its availability and uptake (for 20 example, Best et al., 2005). The absence of good evidence from formal 21 evaluations of the relative efficacy of residential centres compared to 22 community based alternatives may be one reason for this limited expansion in 23 services. In addition little is known about which subgroups of the drug 24 misusing population are most likely to benefit from treatment in residential 25 settings, the relative treatment and cost effectiveness of different types of 26 treatment philosophy, and the cost-effective length of stay in such units. 27 28 The primary focus of drug misuse treatment in the UK has tended of recent 29 years towards harm reduction rather than abstinence. However, recent policy 30 changes have brought a renewed focus on abstinence as a primary treatment 31 goal (NTA ,2005)and in line with this shift in attitude, there has been a 32 growing number of residential facilities in the UK offering abstinence- 33 oriented treatment . Many residential rehabilitation programmes aim to 34 achieve abstinence from substance misuse, offer psychosocial support and 35 provide structured programmes of daily activities, which residents are 36 required to attend. In England, the National Treatment Outcomes Research 37 Study (NTORS; Gossop et al., 1999) has identified 12-step programmes and 38 TCs along with Christian houses as the main providers of residential services. 39 40 12-step-based residential treatment 41 Just under half of the services in the NTA online directory of residential 42 rehabilitation currently describe themselves as 12-step-based (Meier, 2005). 43 The 12-step model, an increasingly broad term stemming from the 12 steps of

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1 the Alcoholics Anonymous (AA) model, assumes that drug users have lost 2 control over their dependence as a result of biological or psychological 3 vulnerability (www.alcoholics-anonymous.org.uk). Treatment attempts to 4 bring about acceptance of the condition by having an ‘addict’ identity, and 5 acceptance of abstinence as the goal of treatment by involvement in 12-step 6 activities (Finney et al., 1998). In the context of residential treatment, residents 7 usually work their way through the steps as part of a planned programme of 8 care, which also involves other individual and group therapeutic activities. 9 The residential element of 12-step programmes is often quite short, lasting no 10 longer than 3 months, but ex-residents will be expected to continue to attend 11 self-help group meetings in the community, for example Narcotics 12 Anonymous (NA) and Cocaine Anonymous (CA). (NTA, 2006b). 13 Therapeutic communities 14 Over half of residential services in the NTA online directory describe 15 themselves as therapeutic communities, which, like 12-step programmes, 16 have abstinence from illicit and prescribed drugs as a primary goal. Where 17 they differ from other treatment approaches is in the use of the residential 18 ‘community’ as the key agent for change. Peer influence is used to help 19 individuals acquire social skills and learn social norms and so take on an 20 increased level of personal and social responsibility within the unit (Smith et 21 al., 2006). In addition to social learning theory-based therapeutic communities, 22 there are rehabilitation centres that emphasise more behavioural, hierarchical 23 principles that positively and negatively reinforce a range of behaviours. 24 Residential therapeutic communities involve therapeutic group work, one-to- 25 one key working, the development of practical skills and interests, education 26 and training. The intensive nature of their approach means that such 27 programmes tend to be longer in duration (6 to 12 months) (Greenwood, 28 2001). 29 The evidence base for residential units 30 There have been a number of cohort studies in the UK, US and Australia that 31 have investigated residential treatment. Many of these have reported 32 improved outcomes (Bennett & Rigby, 1991; De Leon & Jainchill, 1982; 33 Gossop et al, 1999). NTORS included 15 residential rehabilitation units and 34 about half of the service users (51%) had been abstinent from opiates 35 throughout the 3 months prior to 1-year follow-up; rates of injection drug use 36 were also halved, and rates of needle sharing were reduced to less than a 37 third of intake levels (Gossop et al., 1999). 38 39 The NTORS 4–5 year follow-up found that the percentage of residential 40 service users who were abstinent from illicit drug use had increased from 1% 41 at intake to 38% after 4–5 years. Almost half (49%) of the residential service 42 users were abstinent from heroin after the same period (Gossop et al., 2003).In 43 the Drug Abuse Reporting Programme (DARP), Simpson and Sells (1990) 44 found that most of the long-term (12 years) improvement was attained in the 45 first 3 years after treatment. The similarities between the results of the NTORS

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1 and those of studies such as the DARP, Treatment Outcome Prospective 2 Study (TOPS) and Drug Abuse Treatment Outcome Study (DATOS) 3 (Hubbard et al. 1989; Simpson & Sells, 1990; Hubbard et al., 1997) have been 4 noted (for example, Leshner, 1997). 5 6 The US DATOS examined predictors of self-reported health status among a 7 sample comprising 10,010 service users receiving drug misuse treatment. 8 Results revealed that there were good outcomes after one year for service 9 users (n = 2,966) treated using long-term residential and short-term inpatient 10 treatment modalities. Regular cocaine misuse, the most common presenting 11 problem, was reduced to about one third of intake levels among service users 12 from both the long- and short-term programmes, as was regular heroin 13 misuse (Flynn et al., 1997). Rates of abstinence from cocaine and heroin also 14 improved after residential treatment. 15 16 Although these large-scale cohort studies provide some interesting data, there 17 are a number of factors that limit their usefulness in evaluating residential 18 treatment. Firstly, in the cohort studies discussed above, there is a lack of 19 meaningful comparison groups. Therefore, conclusions are limited to before 20 and after changes in outcome for the residential treatment group, with the 21 possibility that changes may be due to spontaneous recovery or some 22 systematic bias in the selection of those who enter residential treatment. 23 Additionally, data from very different residential treatments are often 24 combined, therefore making it impossible to assess the effectiveness of 25 various types of residential treatment. These limitations suggest the need for 26 studies that use appropriate comparison groups and assess the efficacy of 27 specific types of residential treatment.

28 9.3.2 Databases searched and inclusion/exclusion criteria 29 Table 33: Databases searched and inclusion/exclusion criteria for clinical effectiveness of residential treatment Electronic databases MEDLINE, EMBASE,CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006 ; table of contents December 2005 to November 2006 Study design RCT and cohort Patient population People who misuse drugs Interventions Residential interventions Outcomes Abstinence, drug misuse

30 9.3.3 Studies considered14 31 The review team conducted a new systematic search for RCTs and cohort 32 studies that assessed the efficacy of residential interventions. Comparisons

14 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 between residential and community-based treatment, as well as meaningful 2 comparisons between residential treatments, were focused on. 3 4 For the review of therapeutic communities, two RCTs (GREENWOOD2001; 5 NEMES1999) met the eligibility criteria set by the GDG, providing data on 673 6 participants. Both were published in peer-reviewed journals. 7 8 For the review of 12-step residential treatment, one cohort study 9 (FINNEY1998) met the eligibility criteria set by the GDG, providing data on 10 3018 participants. This was published in a peer-reviewed journal. 11 12 For the review comparing residential and day treatments, two RCTs 13 (GREENWOOD2001; SCHNEIDER1996) met the eligibility criteria set by the 14 GDG providing data on 335 participants. Both were published in peer- 15 reviewed journals. 16 17 In addition, 15 studies were excluded from the analysis. The most common 18 reason for exclusion was not providing required outcomes (further 19 information about both included and excluded studies can be found in 20 Appendix 14).

21 9.3.4 Outcomes 22 The primary outcomes assessed were related to abstinence and drug use. 23 Abstinence can be expressed in a variety of ways, but the two main measures 24 examined were point abstinence and duration of abstinence. Measures based 25 on urinalysis were preferred but self-report measures were not excluded. 26 Point abstinence refers to evidence for the absence of drug use at a particular 27 point in time (for example, end of treatment or at 12-month follow-up). 28 Measures of the duration of abstinence over a period of time were also 29 assessed, for example, how long a person remained abstinent, and the 30 proportion of days a person was abstinent over a period of time. 31 32 Frequency of illicit drug use was also an important measure because, 33 although abstinence may be a desired goal, reducing drug misuse may be a 34 more realistic way of reducing drug-related harm. Drug misuse is usually 35 measured by self-report, often in terms of the frequency of using particular 36 drugs over a period of time.

37 9.3.5 Therapeutic communities 38 Table 34: Summary evidence table for trials of therapeutic communities* Residential TC versus 10 months residential + day treatment TC 2 months aftercare versus 6 months residential + 6 months aftercare Total no. of 1 RCT 1 RCT trials (total (N = 261) (N = 412)

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no. of participants) Study ID GREENWOOD 2001 NEMES1999 Problem Crack cocaine: 67% Crack cocaine – drug or percentages not diagnosis Heroin: 13% provided

Alcohol: 10% Treatment 12 months See above length Length of 18 months 12 months follow-up Age (years) 33 No data provided Point 12-month follow-up: Abstinence from abstinence RR 0.90 (0.67 to 1.22) crack/cocaine at 12- K = 1, N = 261 month follow-up: RR 1.10 (0.90 to 1.35) K = 1, N = 412 Duration of - - abstinence Illicit drug - - use *Residential versus day: RR > 1 favours residential 10 months + 2 months versus 6 months + 6 months: RR>1 favours 10 months + 2 months 1 2 Table 34 summarises the data on therapeutic communities. No differences in 3 abstinence at 12-month (RR = 0.90; 95% CI: 0.67 to 1.22) or 18-month (RR = 4 0.86; 95% CI: 0.65 to 1.14) follow-up were found between a residential 5 therapeutic community and a day treatment therapeutic community 6 programme (Greenwood et al., 2001). Nemes and colleagues (1999) found that 7 a 12-month course of treatment that included at least 6 months in a residential 8 therapeutic community followed by community aftercare was as effective as 9 10 months in a residential therapeutic community followed by 2 months of 10 community aftercare in terms of abstinence outcomes. However, the lack of 11 an adequate comparison group (for example, community-based treatment or 12 treatment as usual) makes it difficult to assess the efficacy of either treatment 13 programme. 14 15 It is very difficult to draw conclusions from this data due to the sparseness of 16 the evidence. Furthermore, it is questionable whether the high proportions of 17 participants with a primary crack cocaine problem reported in these studies 18 are comparable with UK residential treatment populations, where only an 19 estimated 3% had a primary stimulant problem (Day et al., 2005). This 20 evidence is consistent with Smith and colleagues (2006), who conducted a 21 systematic review and concluded that there is a lack of research assessing the 22 effectiveness of therapeutic communities or whether one type of therapeutic 23 community is better than another.

24 9.3.6 12-step-based residential rehabilitation 25 26 Table 35: Summary evidence table for trials of 12-step residential treatment* 27

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Residential 12-step Residential 12-step versus1 versus residential RP eclectic residential

Total no. of 1 cohort study 1 cohort study trials (total no. (N ~ 1,500) (N ~ 1,500) of participants) Study ID FINNEY 1998 FINNEY1998 Problem drug Drug dependence Drug dependence (13%) or diagnosis (13%) Drug and alcohol Drug and alcohol dependence (51%) dependence (51%)

Alcohol dependence Alcohol dependence (36%) (36%) Treatment 3 to 4 weeks 3 to 4 weeks length Length of 12 months 12 months follow-up Age (years) 43 43 Point 12-month follow-up: 12-month follow-up: RR abstinence RR 1.25 (1.13 to 1.39), 1.13 (1.01 to 1.25), favours favours 12-step 12-step K = 1, N = 3,018 K = 1, N = 3,018

Drug use - - * RR >1 favours 12-step 2 3 Only one study was found assessing the effectiveness of 12-step-based 4 residential treatment (see 35). This study was a large prospective cohort (n = 5 3,018) that compared 12-step-based residential treatment with relapse- 6 prevention cognitive behavioural therapy and eclectic (combining elements of 7 12-step and cognitive behavioural therapy approaches) residential treatments 8 (Finney et al., 1998). At 12-month follow-up, participants receiving 12-step- 9 based treatment were more likely to remain abstinent and had fewer 10 substance use problems than those in the relapse-prevention cognitive 11 behavioural therapy and eclectic programmes. However, for both 12 comparisons the effect was small and would equate to a number needed to 13 treat of 11 for 12-steps compared with the relapse-prevention cognitive 14 behavioural therapy group and a number needed to treat of 25 for 12-steps 15 compared with the eclectic group. 16

17 9.3.7 Comparison of residential and day treatment 18 There were two trials comparing residential and day treatment (see Table 36). 19

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1 Table 36: Summary evidence table for trials comparing residential with day 2 treatment* Residential treatment versus day treatment

Total no. of 2 RCTs trials (total no. (N = 335) of participants) Study ID GREENWOOD2001 SCHNEIDER1996 Problem drug GREENWOOD2001: or diagnosis Crack cocaine (67%) Heroin (13%) Alcohol (10%)

SCHNEIDER1996: Cocaine dependent (100%)

Treatment GREENWOOD2001 length Residential TC: 40 hours/week plus additional time at weekend for 12 months

Day treatment TC: received in the same treatment centre with the same intensity but did not have the 24-hour structure of the programme

SCHNEIDER1996 Residential: 30-42 hours/week for 2 weeks — group psychoeducation, CBT (RP), 12-step facilitation

Day treatment: 25 hours/week for 2 weeks — group psychoeducation, counselling, CBT (RP), 12-step facilitation Length of 3 months follow-up (SCHNEIDER1996) 12 months to 5 years (GREENWOOD2001) Age (years) 31 to 40 Point Abstinence for TC at 12-month follow-up: RR abstinence 0.90 (0.67 to 1.22) K = 1, N = 261

Abstinence at 3-month follow-up: RR 1.65 (0.99 to 2.74) K=1 N=74

Drug use - *RR>1 favours residential 3 4 One trial compared therapeutic communities in residential and day treatment 5 (Greenwood et al., 2001). All participants received their treatment in the same 6 treatment centre; the first 6 months of treatment was focused on drug misuse 7 problems and the last 6 months helped participants develop independent 8 employment and living arrangements. The main differences between the 9 groups were that the day treatment group did not have the 24-hour structure

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1 experienced by the residential group. Additionally, the requirement of 2 abstinence from illicit drugs was more stringent for the residential group, 3 who received immediate expulsion from the programme for non-compliance. 4 Although abstinence was also a requirement for the day treatment group, this 5 was enforced more flexibly. 6 7 The other included trial compared eclectic residential and day treatment. This 8 intervention was of a much shorter duration of 2 weeks. The residential group 9 was slightly more intensive than the day treatment group, receiving 6 hours a 10 day of treatment. It is not clear whether the same level of intensity was 11 provided during the weekend. The day treatment group received 5 hours of 12 interventions per day from Monday to Friday. Interventions included group 13 relapse-prevention cognitive behavioural therapy, counselling, 14 psychoeducation and 12-step facilitation (Schneider et al., 1996). 15 16 It is not possible to meta-analyse the results of these two studies as they differ 17 in terms of treatment length, content and follow up. Greenwood and 18 colleagues (2001) found no differences between residential and day treatment 19 at 12 month (RR = 0.90; 95% CI: 0.67 to 1.22) or 18 month (RR = 0.86; 95% CI: 20 0.65 to 1.14) follow up. However, Schneider and colleagues (1996) found that 21 participants in the residential group were more likely to be abstinent than 22 those in day treatment at 3 month follow up (RR = 1.65; 95% CI: 0.99 to 2.74).

23 9.3.8 Predictors of benefit from residential rehabilitation 24 The DATOS found that service users with a history of previous residential 25 treatment engagement had poorer outcomes (Anglin et al., 1997; Hser et al., 26 1999), in contrast to clinical practice in the UK, where residential 27 rehabilitation has traditionally been reserved for those who have tried and 28 failed all other community-based options (Day et al., 2005). There is some 29 limited evidence to suggest that drug users with more severe problems will 30 experience better outcomes from treatment stays of 90 days or longer, rather 31 than programmes of shorter duration (Simpson, 1997). The NTORS found 32 that, for cocaine users, improvements in rates of abstinence were found only 33 among those in residential rehabilitation (Gossop et al., 2003). However, the 34 importance of this finding is difficult to interpret as cocaine misuse did not 35 appear to be the primary problem for most participants in this study. 36 37 One issue that affects most research evaluations of residential rehabilitation 38 programmes is that treatment dropout is common. In common with outcomes 39 from other treatment modalities, service users who completed residential 40 programmes achieved better outcomes on drug misuse, crime, employment 41 and other social-functioning measures (De Leon et al., 1982; Hubbard et al., 42 1989). It is unclear whether this relates to choice or motivation on the part of 43 the service user or whether active retention in treatment achieves successful 44 outcomes.

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1 9.3.9 Clinical summary 2 There is a lack of well-conducted studies assessing the efficacy of residential 3 in comparison to community-based treatment for drug misuse and the 4 efficacy of specific types of residential treatment. Additionally, many studies 5 (for example, Finney, 1998) contain samples that have large proportions of 6 participants who do not misuse drugs. Therefore, it is difficult to draw any 7 firm conclusions from the studies on the comparative efficacy of 12-step- 8 based and TC residential treatments or even if these interventions confer any 9 advantages over well delivered community based interventions. Given the 10 relatively high costs of these interventions it is clear that further research in 11 this area is urgently needed. There is some indication of benefit from cohort 12 studies but in the absence of RCT evidence few conclusions can be drawn 13 from these studies. It is also not possible to distinguish the additional benefit 14 that might accrue to an individual from a period in residential rehabilitation 15 over and above that which was obtained from the initial period of 16 detoxification. 17 18 Whilst traditional practice in the UK has been for service users to be referred 19 for residential treatment when they have failed a long period of community 20 care, there is some evidence to suggest that those less well established in their 21 drug using careers may benefit from residential care. 22

23 9.3.10 Clinical practice recommendations

24 9.3.10.1 Residential treatment may be considered for people who 25 have comorbid physical, psychiatric, or social (for example, housing 26 instability) problems and/or have not benefited from previous 27 community-based treatment. Treatment is often associated with a 28 detoxification programme and may be followed by a period of 29 community-based aftercare.

30 9.3.10.2 People who have relapsed to opiate use during or after 31 treatment in an inpatient or residential setting should be offered an 32 urgent assessment and considered for prompt access to alternative 33 community or inpatient support including maintenance treatment.

34 9.3.11 Research recommendation – residential treatment

35 9.3.11.1 For people who misuse drugs, is residential treatment 36 associated with better outcomes compared to community based care 37 as measured by higher rates of abstinence or reduction in drug use? 38 39 Why this is important 40 41 There have been some studies comparing residential treatment with 42 community based treatment. However, these studies are often based on small

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1 sample sizes, lack methodological quality and have produced inconsistent 2 results. Residential treatment requires significantly more resources than 3 community based treatment, therefore it is important to assess whether 4 residential treatment is more effective. 5

6 9.4 Legally mandated treatment interventions

7 9.4.1 Introduction 8 Recently in the UK, drug treatment has increasingly been offered as part of a 9 legal mandate either by order or a court, or by diversion from the judicial 10 system. Commentators have noted that compulsory (also known as legally 11 mandated) treatment and coerced treatment are not necessarily the same. For 12 example, Wild and colleagues (2002) found that evaluations of those 13 mandated to compulsory treatment have shown wide variations in 14 perceptions of coercion, readiness to change their behaviour and perceived 15 justifiability of a mandate to socially control their drug misuse. Additionally, 16 although legally mandated treatment status does predict perceived level of 17 coercion, many legally mandated users do not feel coerced into treatment. 18 Paradoxically, many who self-refer do report feeling coercion, often by family 19 members (Polcin & Weisner, 1999). 20 21 The critical question for NHS services is whether people who misuse drugs 22 who are engaged in criminal activity require criminal sanctions, drug 23 treatment or a combination of both. This section seeks to present the evidence 24 pertaining to the effectiveness of coerced versus voluntary treatment across a 25 number of outcome variables. These outcomes include uptake of treatment, 26 retention in treatment, abstinence from drugs or a reduction in drug taking, 27 and reduction in rates of imprisonment.

28 9.4.2 Databases searched and inclusion/exclusion criteria 29 Table 37: Databases searched and inclusion/exclusion criteria for clinical effectiveness of legally mandated treatment Electronic databases MEDLINE, EMBASE, CINAHL, HMIC, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Observational studies Systematic reviews Patient population People who misuse drugs Interventions Legally mandated drug treatment Outcomes Abstinence, drug misuse

30 31 For the review of legally mandated treatment, one systematic review 32 (WILD2002) met the eligibility criteria set by the GDG. This review was 33 published in a peer-reviewed journal.

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1 9.4.3 Comparisons of legally mandated and voluntary treatment 2 Most of the research in this area has been conducted in the USA. Wild and 3 colleagues’ (2002) systematic review showed that mandated treatment 4 generally demonstrated better outcomes in terms of treatment process; that is, 5 uptake of treatment following referral and retention in treatment. However, 6 mandated treatment was not superior to voluntary treatment in terms of 7 reductions in criminal behaviour or substance misuse. 8 9 A 12-month prospective cohort study in Australia of 92 heroin users 10 compared those mandated to treatment with those who self-referred. They 11 found that cumulative incarceration rates were higher in the mandated group 12 than the voluntary treatment group, though the mandated group was more 13 problematic (that is, had lower levels of education and employment and 14 higher levels of antisocial behaviour) at baseline (Dresland & Batey, 1992). 15 16 A US-based study of 610 service users compared those mandated to 17 methadone maintenance with those who accessed methadone maintenance 18 voluntarily. They found a higher dropout rate, due to incarceration, for those 19 mandated to treatment. However, there was no difference between the groups 20 at 1-year follow-up for percentage of positive urine samples (Desmond & 21 Maddux, 1996).

22 9.4.4 Clinical summary 23 There has been limited research assessing the efficacy of legally mandated 24 treatment. Despite potential concerns of some commentators the evidence 25 reviewed above does suggest that the more negative outcomes found in 26 legally mandated treatments may be explained by the nature of the difficulties 27 of those entering mandated treatment when compared to those in voluntary 28 treatment rather than its compulsory nature.

29 9.4.5 Clinical practice recommendation

30 9.4.5.1 For people who misuse drugs, access to and choice of 31 treatment should be the same whether they participate in treatment 32 voluntarily or are legally required to do so.

33 9.5 Prison 34 Relatively few studies have evaluated the effectiveness of prison-based 35 psychosocial interventions. In this section, research findings are presented for 36 the effectiveness of the following interventions based in the prison setting: 37 therapeutic communities use the residential ‘community’ as the key agent for 38 change. Peer influence is used to help individuals acquire social skills and 39 learn social norms and so take on an increased level of personal and social 40 responsibility within the unit (Smith et al., 2006). Therapeutic communities 41 involve therapeutic group work, one-to-one key working, the development of 42 practical skills and interests, education and training. The intensive nature of

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1 their approach means that such programmes tend to be longer in duration (6– 2 12 months) (Greenwood, 2001). 3 4 Therapeutic community work release programmes are for people who have 5 been released from prison and who misuse drugs. They consist of 6 community-based residential therapeutic community programmes with 7 additional emphasis on assisting former prisoners to enter employment. 8 9 Boot camps refer to the delivery of the correctional intervention within a 10 paramilitary style of working.

11 9.5.1 Databases searched and inclusion/ exclusion criteria 12 Information about the databases searched and the inclusion/ exclusion 13 criteria used for this section of the guideline can be found in Table 38. 14 Table 38: Databases searched and inclusion/ exclusion criteria for clinical effectiveness of prison-based psychosocial interventions Electronic databases MEDLINE, EMBASE, PsycINFO, Cochrane Library Date searched Database inception to May 2006; table of contents December 2005 to November 2006 Study design RCT Observational studies Patient population People who misuse drugs Interventions Prison-based treatment: therapeutic communities, 12-steps Community-based post-release residential treatment: therapeutic communities, 12-steps Boot camps, shock incarceration Outcomes Abstinence, drug misuse, reincarceration, recidivism, criminal activity

15 9.5.2 Studies considered15 16 The review team conducted a new systematic search for RCTs and 17 observational studies that assessed the efficacy of prison-based and post- 18 release treatment. 19 20 For the prison-based and post-release therapeutic community review, three 21 RCTs (NEILSEN1996; SACKS2003; WEXLER1999) met the eligibility criteria 22 set by the GDG, providing data on 1,682 participants. All of these were 23 published in peer-reviewed journals. 24 25 For the review of boot-camps, two studies conducted by (ZHANG2000) met 26 the eligibility criteria. These studies were published in a peer-reviewed 27 journal. 28

15 Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

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1 In addition, 12 studies were excluded from the analysis. The most common 2 reason for exclusion was unrequired outcomes (further information about 3 both included and excluded studies can be found in Appendix 14). 4

5 9.5.3 Outcomes 6 7 Relapse is referred to here as the use of any illicit drugs during treatment or 8 at follow-up. 9 10 Illicit drug use is the frequency of illicit drug use over a period of time and is 11 usually measured by self-report. 12 13 Criminal activity is referred to here as the frequency of criminal activities 14 committed by a person. This is often measured by self-report as not all 15 criminal activity will be officially detected. 16 17 Recidivism is the frequency of a person being arrested and charged for 18 criminal activity. 19 20 Reincarceration refers to whether a person who has been released from 21 prison has returned to prison after a particular period of time. 22 23 24 Table 39: Summary evidence table for trials of prison and work release 25 therapeutic communities, and boot camps* Prison TC + aftercare versus Residential TC work release Boot camp versus traditional prison control programmes juvenile camp versus standard aftercare Total no. of 2 RCTs 1 RCT Retrospective cohort study trials (total no. (N = 993) (N = 688) (N = 854) of participants) Study ID SACKS2003 NEILSEN1996 ZHANG2000 WEXLER1999 Diagnosis Drug: 20% crack/cocaine, Cocaine: 40% Drug and/or alcohol history 30% cannabis, 30% alcohol Crack: 11% Psychiatric: 70% Axis I, 39% ASPD Heroin: 13% (SACKS2003) Cannabis:11% Drug: 100% illicit drug use Alcohol: 13% Psychiatric: 51.5% ASPD (WEXLER1999) Treatment 1 year prison TC and 1 year 6 months 6 months′ boot camp and 6 length community-based aftercare months′ aftercare (WEXLER1999)

1 year prison TC and 6 months′ community-based aftercare (WEXLER1999) Length of 1 to 5 years 1 year 1 year

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follow-up Illicit drug use - Relapse 6-month follow-up: Illicit drug use RR 0.49 (0.41 to 0.58) 12-month follow-up: SMD - K = 1, N = 688 0.21 (-0.49 to 0.06) K = 1, N = 200 Crime Reincarceration: Recidivism 6-month follow- Arrested 12-month follow-up: RR 0.48 up: RR 0.65 (0.53 to 0.78) 12-month follow-up: RR 0.95 (0.20 to 1.12) K =1, N = 688 (0.73 to 1.22) K = 2, N = 854 K = 1, N = 200

5-year follow-up: RR 0.93 Arrested (0.87 to 0.99) 4-year follow-up: RR 0.99 K = 1, N = 715 (0.94 to 1.05) K = 1, N = 854 Criminal activity: RR 0.69 (0.52 to 0.93), K = 1, N = 139 * RR < 1 favours intervention; negative SMD values favour intervention 1

2 9.5.4 Therapeutic communities 3 Three RCTs have been conducted in the prison setting evaluating the 4 evidence for psychosocial interventions. All of the three RCTs evaluated 5 therapeutic communities and were conducted in the USA (NIELSEN1996; 6 SACKS2004; WEXLER1999). In two of the three trials the intervention 7 included treatment within prison followed by release to a residential 8 community of 6 months’ duration (SACKS2004; WEXLER1999). The third trial 9 (NIELSEN1996) assessed a work release therapeutic community programme. 10 11 The main outcomes were for crime and relapse and were assessed over a 12 follow-up period of up to 5 years. In summary, therapeutic community prison 13 and aftercare programmes and therapeutic community work release 14 programmes were associated with reductions in criminal activity (RR = 0.69; 15 95% CI: 0.52 to 0.93), recidivism (RR = 0.65; 95% CI: 0.53 to 0.78) and relapse 16 (RR = 0.49; 95% CI: 0.49 to 0.58). For reincarceration, the difference was not 17 statistically significant at 12-month follow-up (RR = 0.48; 95% CI: 0.20 to 1.12) 18 but there was a strong trend favouring prison therapeutic communities, with 19 a number needed to treat of 5. At 5-year follow-up the difference was 20 statistically significant (RR = 0.93; 95% CI: 0.87 to 0.99).

21 9.5.5 Boot camps 22 There was a retrospective cohort study on boot camps with a total of 854 23 participants reported by a team of researchers in the US ( Zhang 2000). 24 Participants in boot camps did not differ from controls for drug use at 12- 25 month follow up (SMD = -0.21; 95% CI: -0.49 to 0.06) and for proportion 26 arrested at 12 months (RR = 0.95; 95% CI: 0.73 to 1.22) and 4 years (RR = 0.99; 27 95% CI: 0.94 to 1.05).

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1 9.5.6 Clinical summary 2 The therapeutic community approach in prison settings in the United States 3 appeared to be associated with a reduction in reincarceration rates, criminal 4 activity and recidivism and these effects were maintained at follow up. The 5 evidence also suggests that, subsequent to release from prison, continuing 6 community-based interventions such as therapeutic community attendance or 7 involvement in community-based work programmes may be important in 8 maintaining the benefits of the intervention. In contrast, boot camps do not 9 appear to be effective for offenders who misuse drugs — no differences were 10 reported on crime outcomes and drug misuse at follow-up.

11 9.5.7 Clinical practice recommendations

12 9.5.7.1 For people in prison with drug misuse problems, treatment 13 options offered should be broadly equivalent to those available in the 14 community. Healthcare professionals should take into account 15 additional considerations specific to the prison setting, which include: 16 • length of sentence or remand, and the possibility of unplanned 17 release 18 • risk of self-harm, death and post-release overdose.

19 9.5.7.2 People in prison with significant drug misuse problems 20 should be offered access, if appropriate, to a therapeutic community 21 developed for the specific purpose of treating drug misuse within the 22 prison environment.

23 9.5.7.3 For people who have made an informed and appropriate 24 decision to receive drug treatment after release from prison, 25 community-based residential treatment should be arranged as part of 26 an overall care plan. 27

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1 10 Appendices

2 Appendix 1: Scope for the development of the clinical guideline...... 172

3 Appendix 2: Special advisors to the Guideline Development Group...... 179

4 Appendix 3: Stakeholders who responded to early requests for evidence ...... 180

5 Appendix 4: Stakeholders and experts who responded to the consultation draft of 6 the guideline...... 181

7 Appendix 5: Researchers contacted to request information about unpublished or 8 soon-to-be published studies...... 183

9 Appendix 6: Clinical questions...... 184

10 Appendix 7: Search strategies for the identification of clinical studies ...... 186

11 Appendix 8: Clinical study data extraction form...... 193

12 Appendix 9: Quality checklists for clinical studies and reviews ...... 195

13 Appendix 10: Search strategies for the identification of health economics evidence 14 ...... 207

15 Appendix 11: Quality checklists for economic studies ...... 213

16 Appendix 12: Data extraction form for economic studies...... 216

17 Appendix 13: Evidence tables for economic studies...... 219 18 19 Supplied as separate files on the website: 20

21 Appendix 14: Included/excluded study information tables

22 Appendix 15: Clinical evidence forest plots

23 Appendix 16: GRADE evidence profiles

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1 Appendix 1: Scope for the development of the clinical guideline

2 Final version 3 4 28th September 2005 5 6 Guideline title 7 8 Drug misuse: psychosocial management of drug misusers in the community 9 and in prison16. 10 11 Short title 12 Drug misuse – psychosocial interventions17. 13 14 Background 15 16 The National Institute for Health and Clinical Excellence (‘NICE’ or ‘the 17 Institute’) has commissioned the National Collaborating Centre for Mental 18 Health (NCCMH) to develop a clinical guideline on psychosocial 19 management of drug misusers18 in the community and prison settings, for use 20 in the NHS in England and Wales. This follows referral of the topic by the 21 Department of Health (see Appendix below). The guideline will provide 22 recommendations for good practice that are based on the best available 23 evidence of clinical and cost effectiveness. 24 25 The Institute has simultaneously commissioned the NCCMH to develop a 26 clinical guideline on opiate detoxification of people who misuse drugs in the 27 community, hospital and prison settings for use in the NHS in England and 28 Wales. 29 30 The Institute’s clinical guidelines will support the implementation of National 31 Service Frameworks (NSFs) in those aspects of care where a Framework has 32 been published. The statements in each NSF reflect the evidence that was 33 used at the time the Framework was prepared. The clinical guidelines and 34 technology appraisals published by the Institute after an NSF has been issued 35 will have the effect of updating the Framework. 36 37 NICE clinical guidelines support the role of healthcare professionals in 38 providing care in partnership with patients, taking account of their individual 39 needs and preferences, and ensuring that patients (and their carers and

16 The guideline title changed during the development process to Drug Misuse: Psychosocial Management of Drug Misuse 17 The short title changed during the development process to Drug Misuse - Psychosocial 18 The term drug misusers has been replaced with people who misuse drugs throughout the guideline, with the exception of the scope

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1 families, where appropriate) can make informed decisions about their care 2 and treatment. 3 4 Clinical need for the guideline 5 6 The term opiate is used throughout this scope. Although this term normally 7 implies substances containing natural opium, in this scope the term is used 8 more broadly to include opioids (synthetic substances with similar 9 properties). 10 11 It is estimated that there are between 250,000 and 500,000 problem drug users 12 in the UK, of whom about 125,500 are in treatment in any year. There is a 13 government target of ensuring 200,000 are in effective treatment in 2008. The 14 majority of those requiring treatment are opiate dependent (and currently or 15 previously using illicit heroin), although the use of other drugs such as 16 stimulants (for example cocaine) is known to be increasing. 17 18 Severe opiate dependence is a disorder of multi-factorial aetiology, with 19 multiple and varied perpetuating factors. It has a central feature of 20 psychological reinforcement of repeated drug-taking behaviour and it also 21 has a marked withdrawal syndrome. Disturbances of the brain reward 22 pathways may be important underlying pathological mechanisms. For this 23 reason, it is usually considered that a range of interventions may be required 24 in addition to pharmacological treatments. 25 26 There may be associated problems of family, social and criminal justice 27 difficulties, health problems including blood-borne viruses, and other drug 28 and alcohol problems. Families themselves may be affected by the drug 29 misuse and are often a major resource in resolving problems and supporting 30 the family member through treatment. 31 32 For people with severe drug dependency and others with long-standing 33 dependency, the disorder has characteristics as a long-term chronic relapsing 34 disorder with periods of remission and relapse, so while abstinence may be 35 one of a range of long-term goals of treatment, it is not always achieved. Even 36 when abstinence is achieved, the benefits are not always maintained, and 37 periods of relapse may still occur. 38 39 The societal costs of drug misuse have been estimated at many billions of 40 pounds, with opiate dependence and use of other Class A drugs constituting 41 the main cause of these costs. 42 43 Opiate substitution therapies (methadone and buprenorphine are most 44 commonly used) allow the patient to replace street heroin with a longer- 45 acting, less euphoriant and safer drug, while avoiding the withdrawal 46 syndrome. Once stabilised, many patients remain on maintenance treatment,

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1 which brings improvements in illicit drug use, physical health, well-being, 2 social stabilisation and reduced criminality and costs to society. 3 Pharmacological treatments for stimulant and cannabis misuse are not well 4 developed. 5 6 Psychosocial interventions play an important part in the treatment of drug 7 misusers. For opiate misusers they are often an important adjunct to 8 pharmacological treatments and have been demonstrated to be effective. For 9 stimulant misusers, psychosocial interventions are the mainstay of effective 10 treatment interventions and there is an established evidence base. A similar, 11 but less well-developed, evidence base also exists for psychosocial 12 interventions for cannabis misusers. 13 14 People who misuse drugs in prison sometimes receive assistance with 15 withdrawal symptoms and some receive a treatment programme in prison. 16 Access to regular high levels of illicit drugs in prisons is limited, so most 17 people with drug dependency lose tolerance and are at risk of overdose if – as 18 commonly happens – they begin using again on release. 19 20 The guideline 21 22 The guideline development process is described in detail in two publications, 23 which are available from the NICE website (see ‘Further information’). The 24 Guideline Development Process – an Overview for Stakeholders, the Public and the 25 NHS (Second Edition) (NICE, 2006) describes how organisations can become 26 involved in the development of a guideline. The Guidelines Manual (NICE, 27 2006) provides advice on the technical aspects of guideline development. 28 29 This document is the scope. It defines exactly what this guideline will (and 30 will not) examine, and what the guideline developers will consider. The scope 31 is based on the referral from the Department of Health (see Appendix below). 32 33 The areas that will be addressed by the guideline are described in the 34 following sections: 35 36 Population 37 38 Groups that will be covered: 39 40 • adults and young people who misuse opiates

41 • adults and young people who misuse cannabis

42 • adults and young people who misuse stimulants (for example, 43 cocaine or amphetamines)

44 • adults and young people who misuse more than one of the above.

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1 2 Groups that will not be covered: 3 4 • Adults and young people with dual diagnoses, where the primary 5 diagnosis and focus of intervention is not substance misuse but 6 another mental disorder, for example depression, schizophrenia or 7 other psychoses. Where appropriate, this guideline will refer to 8 other NICE guidance for the treatment of other mental health 9 disorders.

10 • Adults and young people who misuse alcohol, where the primary 11 diagnosis and focus of intervention is alcohol misuse.

12 • Adults and young people who misuse prescription drugs, for 13 example benzodiazepines.

14 • Adults and young people who misuse solvents (for example, 15 aerosols and glue) or other street drugs (for example, LSD [lysergic 16 acid diethylamide]).

17 • Adults and young people prescribed opiates and related drugs for 18 therapeutic purposes unrelated to substance misuse.

19 20 Healthcare setting 21 22 The guideline will be of relevance to the NHS and related organisations, 23 including: 24 25 • prison services

26 • inpatient and specialist residential and community-based treatment 27 settings.

28 29 This is an NHS guideline. Although it will comment on the interface with 30 other services such as those provided by social services, educational services 31 and the voluntary sector, it will not provide specific recommendations 32 directed solely to non-NHS services, except insofar as they are provided 33 under contract to the NHS. 34 35 Clinical management – areas that will be covered 36 37 The guideline will cover the following areas of clinical practice and will do so 38 in a way that is sensitive to the cultural, ethnic and religious backgrounds of 39 people who misuse drugs/ are drug dependent and their families and carers. 40

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1 • The guideline will include advice on the appropriate use of 2 individual and group structured psychosocial interventions 3 including their type, modality, frequency and duration. The 4 psychosocial interventions considered may include motivational 5 interviewing, cognitive behavioural therapy, contingency 6 management, brief reinforcement-based intensive outpatient 7 therapy, cue exposure therapy, programmes for treatment drop- 8 outs, enhanced outreach counselling programmes, vocational 9 rehabilitation programmes, family- and couple-based interventions 10 and other psychological interventions provided in the NHS.

11 • The guideline will include the appropriate use of combination 12 individual and/or group structured psychosocial interventions 13 with pharmacological treatments. The pharmacological treatments 14 will include methadone, buprenorphine, naltrexone and other 15 appropriate pharmacological therapies.

16 • When referring to pharmacological treatments, the guideline will, 17 wherever possible, recommend use within their licensed 18 indications. However, where the evidence clearly supports it, 19 recommendations for use outside the licensed indications may be 20 made in exceptional circumstances.

21 • The safety, side effects and other disbenefits of the interventions 22 reviewed will be considered.

23 • The guideline will address, where relevant, the issues of relapse 24 prevention and the minimisation of harm and drug-related deaths

25 • The guideline will include guidance on risk management and 26 suicide prevention, including appropriate assessment and aftercare.

27 • The guideline will address the integration of the interventions 28 reviewed with a broad approach to the care and treatment of people 29 who misuse drugs/are drug dependent and their families and 30 carers.

31 • The guideline will consider the separate needs of families and 32 carers as well as addressing the potential positive contribution of 33 family and carers in the treatment and support of people who 34 misuse drugs/ are drug dependent.

35 • The guideline will address the various needs for information of 36 patients, families and carers, at different stages of their treatment 37 and in different settings, including the role of self-help 38 interventions and of support and self help groups.

39

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1 Clinical management – areas that will not be covered 2 3 • The guideline will not consider diagnosis or primary prevention.

4 5 Status

6 Scope 7 8 This is the final draft of the scope following consultation, which will be 9 reviewed by the Guidelines Review Panel and the Institute’s Guidance 10 Executive. 11 12 The guideline will incorporate the following NICE guidance, which is 13 published or in development: 14 15 Methadone and Buprenorphine for the Treatment of Opiate Drug Misuse. NICE 16 technology appraisal. (Publication expected March 2007.) 17 18 Naltrexone to Prevent Relapse in Drug Misuse. NICE technology appraisal. 19 (Publication expected March 2007.) 20 21 Drug Misuse: Opiate Detoxification of Drug Misuse. NICE clinical guideline. 22 (Publication expected July 2007.) 23 24 Schizophrenia: Core Interventions in the Treatment and Management of 25 Schizophrenia in Primary and Secondary Care. NICE clinical guideline no. 1 26 (2002). 27 28 Anxiety: Management of Anxiety (Panic Disorder, with or without Agoraphobia, and 29 Generalised Anxiety Disorder) in Adults in Primary, Secondary and Community 30 Care. NICE clinical guideline no. 22 (2004). 31 32 Depression: Management of Depression in Primary and Secondary Care. NICE 33 clinical guideline no. 23 (2004). 34 35 Self-Harm: the Short-Term Physical and Psychological Management and Secondary 36 Prevention of Self-Harm in Primary and Secondary Care. NICE clinical guideline 37 no. 16 (2004). 38 39 Guideline 40 41 The development of the guideline recommendations will begin in September 42 2005. 43 44 Further information 45

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1 Information on the guideline development process is provided in: 2 3 • The Guideline Development Process – an Overview for Stakeholders, the 4 Public and the NHS (Second Edition) (NICE, 2006)

5 • The Guidelines Manual (NICE, 2006)

6 7 These booklets are available as PDF files from the NICE website 8 (www.nice.org.uk). Information on the progress of the guideline will also be 9 available from the website. 10 11 Appendix – referral from the Department of Health 12 13 The Department of Health asked the Institute to prepare a guideline for the 14 NHS in England and Wales on the psychosocial management of drug 15 misusers in the community and prison settings. 16 17 The guidance will: 18 19 • by using the evidence base, examine the effectiveness and cost 20 effectiveness of psychosocial interventions for the management of 21 opiate, stimulant and cannabis misusers

22 • identify those groups of drug misusers who are most likely to 23 benefit from psychosocial interventions

24 • identify the key components of the effectiveness of these 25 treatments, within a wider package of pharmacological 26 interventions, and the overall care provided for drug misusers.

27 28 29 30

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1 Appendix 2: Special advisors to the Guideline Development Group

2 The Guideline Development Group and the National Collaborating Centre for 3 Mental Health review team would like to thank the following people, who 4 acted as advisors on specialist topics: 5

6 7 8 9 10 11 12 13

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1 Appendix 3: Stakeholders who responded to early requests for evidence

2 College of Occupational Therapists 3 Community Health Sciences, Edinburgh University, and Muirhouse Medical 4 Group 5 Darwin Centre for Young People 6 Derbyshire Mental Health Services NHS Trust 7 Pfizer Ltd 8 Royal College of Nursing 9 Royal College of Pathologists 10 Royal Pharmaceutical Society of Great Britain 11 Royal College of Physicians of Edinburgh 12 Royal College of Psychiatrists 13 SCAN 14 Sheffield Teaching Hospitals NHS Foundation Trust 15 16

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1 Appendix 4: Stakeholders and experts who responded to the consultation 2 draft of the guideline

3 Stakeholders 4

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1 2 3 Experts

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1 Appendix 5: Researchers contacted to request information about 2 unpublished or soon-to-be published studies

3 Amanda Baker 4 Donald A. Calsyn 5 Kathleen M. Carroll 6 Paul Crits-Christoph 7 Michael J. Crawford 8 George DeLeon 9 Karen K. Downey 10 William Fals-Stewart 11 David Farabee 12 Michael Gossop 13 Edward Gottheil 14 Joseph Guydish 15 Stephen Higgins 16 Martin Y. Iguchi 17 Hendree E. Jones 18 Kimberly C. Kirby 19 Thomas Kosten 20 Susanne MacGregor 21 Jim McCambridge 22 Jane McCusker 23 James McKay 24 Jesse Milby 25 William Miller 26 Jo Neale 27 Ashwin A. Patkar 28 Nancy Petry 29 Richard Rawson 30 Damaris J. Rohsenow 31 Grace A. Rowan-Szal 32 Joy M. Schmitz 33 Harvey Siegal 34 Kenneth Silverman 35 Robert Stephens 36 Maxine Stitzer 37 Betty Tai 38 Olivia Washington 39 Stephen P. Weinstein 40 Roger Weiss 41 George Woody 42 David A. Zanis 43

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1 Appendix 6: Clinical questions

2 Tier 1: Drug-related information and advice, screening and referral by 3 generic services 4 5 1) Are there sensitive and specific methods for the identification of people 6 who misuse drugs in health and social care settings where drug misuse is 7 prevalent or where presentations are associated with drug misuse as an 8 aetiological factor? 9 10 Tier 2: Open access, non-care-planned drug-specific interventions 11 12 2) For people who misuse drugs, are there effective psychosocial components 13 of drug agencies* associated with reduced injection risk behaviours, reduced 14 incidence of blood-borne diseases and engagement in treatment? 15 16 *including needle and syringe exchange programmes, drop-in centres and 17 outreach services 18 19 3) For people who misuse drugs, are brief interventions associated with 20 engagement in treatment, reduction/abstinence in use of drug(s)? 21 22 3.1) For people who misuse drugs, are interventions of a longer 23 duration (for example, 12 weeks or more) compared with brief interventions 24 associated with a reduction in the use of drug(s)/ abstinence and reduced risk 25 of relapse at follow-up? 26 27 Tier 3: Structured, care-planned drug treatment 28 29 4) For people who misuse drugs, what structured psychosocial interventions 30 are associated with a reduction in the use of drug(s)/abstinence and reduced 31 risk of relapse at follow-up? 32 33 5) For people who misuse drugs, what structured psychosocial interventions 34 in combination with pharmacological interventions are associated with a 35 reduction in the use of drug(s)/abstinence and reduced risk of relapse at 36 follow-up? 37 38 Tier 4: Residential settings 39 40 6) For people who misuse drugs, are residential settings associated with a 41 reduction in use of drug(s) /abstinence and reduced risk of relapse at follow- 42 up? 43 44 6.1) For people who misuse drugs, are there particular subgroups who 45 are more likely to benefit from treatment in residential settings?

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1 2 7) For people who misuse drugs, are coerced interventions in comparison 3 with no treatment and/or prison associated with reduced risk of relapse at 4 follow-up and reduced crime? 5

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1 Appendix 7: Search strategies for the identification of clinical studies

2 1 General search filters 3 4 Drug misuse 5 6 a. MEDLINE, EMBASE, PsycINFO, CINAHL — Ovid interface 7 8 1 Amphetamine-related disorders/ 9 2 Cannabis addiction/ or Marijuana abuse/ 10 3 Cocaine dependence/ or Cocaine-related disorders/ 11 4 Heroin addiction/ 12 5 exp Narcotic dependence/ 13 6 Opiate addiction/ or exp Opioid-related disorders/ 14 7 Drug abuse/ or Drug abuse pattern/ or Drug addiction/ or Drug misuse/ or Drug 15 overdoses/ or Intravenous drug abuse/ or Substance abuse/ or Substance-related 16 disorders/ or "Substance use disorders"/ 17 8 Drug dependence/ or Drug dependency/ or Substance dependence/ 18 9 Multiple drug abuse/ or Polydrug abuse/ 19 10 Neonatal abstinence syndrome/ 20 11 Psychoses, substance-induced/ 21 12 Substance abuse, intravenous/ 22 13 Substance abuse, perinatal/ 23 14 Substance withdrawal syndrome/ 24 15 (((stimulant$ or polydrug$ or drug$1 or substance) adj3 (abstain$ or abstinen$ or 25 abus$ or addict$ or (excessive adj use$) or dependen$ or disorder$ or intoxicat$ or 26 misuse$ or over dos$ or overdos$ or (use$ adj (disorder$ or illicit)) or withdraw$)) or 27 (drug$1 adj user$)).tw. 28 16 or/1-15 29 17 exp amphetamines/ or exp amphetamine derivative/ 30 18 exp Cannabis/ 31 19 exp CNS stimulating drugs/ or exp central nervous system stimulants/ or exp 32 central stimulant agent/ or exp psychostimulant agent/ 33 20 exp Cocaine/ 34 21 Diamorphine/ or exp Heroin/ 35 22 exp Methadone/ 36 23 exp Narcotic agent/ or exp Narcotics/ 37 24 Naltrexone$.sh. 38 25 exp Opiate/ or exp Opiates/ or exp Opium/ 39 26 (amphetamine$ or crank or dextroamphetamine$ or methamphetamine$ or speed or 40 uppers).tw. 41 27 (Adrafinil$ or Amphetaminil$ or Butanamine$ or Benzphetamine$ or Bromantan$ or 42 Chloramphetamine$ or Deanol$ or Dexamphetamine$ or Dexmethylphenidate$ or 43 Dimethoxy or Methylamphetamine$ or Hydroxyamphetamine$ or Lefetamine$ or 44 Meclofenoxate$ or Mefexamide$ or Methcathinone$ or Methoxyamphetamine$ or 45 Methylamphetamine$ or Methylphenidate$ or Modafinil$ or Pemoline$ or 46 Picamilon$ or Sydnocarb$ or Sydnofen$ or Tetrabenazine$).mp. 47 28 (Butanamine$ or Methylamphetamine$ or Methylenedioxymethamphetamine$ or 48 Ethylbarbituric Acid$ or Allylglycine$ or Amfonelic Acid$ or Amiphenazole$ or 49 Apomorphine$ or Bemegride$ or Benzphetamine$ or Brucine$ or Carphedon$ or 50 Cathinone$ or Chloramphetamine$ or Convulsant Agent or Cropropamide$ or 51 Crotetamide$ or Dexamphetamine$ or Dexoxadrol$ or Dextroamphetamine$ or 52 Dimefline$ or Dimetamfetamine$ or Doxapram$ or Ephedrine$ or Etamivan$ or 53 Ethimizole$ or Methylenedioxyamphetamine$ or Fencamfamin$ or Fenetylline$ or

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1 Flurothyl$ or Fominoben$ or Harmaline$ or Homococaine$ or 2 Hydroxyamphetamine$ or Lobeline$ or Mazindol$ or Meclofenoxate$ or 3 Mefexamide$ or Methamphetamine$ or Methcathinone$ or Methylephedrine$ or 4 Methylphenidate$ or Ethylamphetamine$ or Nikethamide$ or Norcocaine$ or 5 Pemoline$ or Pentetrazole$ or Phenmetrazine$ or Phentermine$ or Picrotoxin$ or 6 Pipradol$ or Prethcamide$ or Prolintane$ or Pseudoephedrine$ or Pyrovalerone$ or 7 Racephedrine$ or Strychnine$ or Butylbicycloorthobenzoate$ or 8 Butylbicyclophosphorothioate$ or Tetramethylsuccinimide$ or Theodrenaline$).mp. 9 29 (analeptic$ or psychostimulant$ or stimulant$).tw. 10 30 (cannabis or hashish or marihuana or marijua$).mp. 11 31 (cocaine or crack).tw. 12 32 (diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 13 phenmetrazine or phendimetrazine or phenylpropanolamine).mp. 14 33 (heroin or diacetylmorphine or diamorphine or morphin$ or morfin$ or smack).tw. 15 34 methadone.tw. 16 35 (antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 17 trexan or vivitrex).tw. 18 36 (opiate$ or opioid$ or opium).mp. 19 37 (ardinex or codein$ or isocodein$ or codipertussin or codyl or methyl morfine or 20 methylmorfine or methyl morphine or methylmorphine or morphine 3 methyl ether 21 or morphine methyl ether or morphine monomethyl ether or pentuss or trans 22 codeine or 467-15-2).mp,rn. 23 38 (dihydrocodeine or codhydrin$ or codicontin or cohydrin or dehacodin or Df 118 or 24 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 25 hydrocodin or nadein$ or napacodin or novicodin or paracodein or paracodin or 26 paramol or parzone or rapacodin or remedacen or tiamon mono or 5965-13-9).mp,rn. 27 39 or/17-38 28 40 (abstain$ or abstinen$ or abus$ or addict$ or (drug adj use$) or (excessive adj use$) or 29 dependen$ or (inject$ adj2 drug$) or intoxicat$ or misus$ or over dos$ or overdos$ or 30 (use$ adj (disorder$ or illicit)) or withdraw$).mp. 31 41 and/39-40 32 42 or/16,41 33 34 35 b. Cochrane Database of Systematic Reviews — Wiley Interscience interface 36 37 #1 MeSH descriptor Amphetamine-Related Disorders, this term only in MeSH products 38 #2 MeSH descriptor Substance-Related Disorders, this term only in MeSH products 39 #3 MeSH descriptor Cocaine-Related Disorders, this term only in MeSH products 40 #4 MeSH descriptor Marijuana Abuse, this term only in MeSH products 41 #5 MeSH descriptor Neonatal Abstinence Syndrome, this term only in MeSH products 42 #6 MeSH descriptor Opioid-Related Disorders explode all trees in MeSH products 43 #7 MeSH descriptor Psychoses, Substance-Induced, this term only in MeSH products 44 #8 MeSH descriptor Substance Abuse, Intravenous, this term only in MeSH products 45 #9 MeSH descriptor Substance Withdrawal Syndrome, this term only in MeSH products 46 #10 (stimulant* or polydrug* or drug* or substance) near (abstain* or abstinen* or abus* 47 or addict* or dependen* or disorder* or intoxicat* or misuse* or over dos* or overdos* 48 or withdraw*) in All Fields in all products 49 #11 drug user* in All Fields in all products 50 #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) 51 #13 MeSH descriptor Amphetamines explode all trees in MeSH products 52 #14 MeSH descriptor Cannabis, this term only in MeSH products 53 #15 MeSH descriptor Central Nervous System Stimulants explode all trees in MeSH 54 products 55 #16 MeSH descriptor Cocaine explode all trees in MeSH products 56 #17 MeSH descriptor Heroin, this term only in MeSH products

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1 #18 MeSH descriptor Methadone explode all trees in MeSH products 2 #19 MeSH descriptor Narcotics explode all trees in MeSH products 3 #20 MeSH descriptor Opium explode all trees in MeSH products 4 #21 amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed in 5 All Fields in all products 6 #22 Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* or 7 Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 8 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 9 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or 10 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 11 or Sydnocarb* or Sydnofen* or Tetrabenazine* in All Fields in all products 12 #23 Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 13 Ethylbarbituric Acid* or Allylglycine* or Amfonelic Acid* or Amiphenazole* or 14 Apomorphine* or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or 15 Cathinone* or Chloramphetamine* or Convulsant Agent* or Cropropamide* or 16 Crotetamide* or Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or 17 Dimefline* or Dimetamfetamine* or Doxapram* or Ephedrine* or Etamivan* or 18 Ethimizole* or Methylenedioxyamphetamine* in All Fields in all products 19 #24 Fencamfamin* or Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or 20 Homococaine* or Hydroxyamphetamine* or Lobeline* or Mazindol* or 21 Meclofenoxate* or Mefexamide* or Methamphetamine* or Methcathinone* or 22 Methylephedrine* or Methylphenidate* or Ethylamphetamine* or Nikethamide* or 23 Norcocaine* or Pemoline* or Pentetrazole* or Phenmetrazine* or Phentermine* or 24 Picrotoxin* or Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or 25 Pyrovalerone* or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 26 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* in All 27 Fields in all products 28 #25 analeptic* or psychostimulant* or stimulant* in All Fields in all products 29 #26 cannabis or hashish or marihuana or marijua* in All Fields in all products 30 #27 cocaine or crack in All Fields in all products 31 #28 diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 32 phenmetrazine or phendimetrazine or phenylpropanolamine in All Fields in all 33 products 34 #29 heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack in All 35 Fields in all products 36 #30 methadone in All Fields in all products 37 #31 antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 38 trexan or vivitrex in All Fields in all products 39 #32 opiate* or opioid* or opium in All Fields in all products 40 #33 ardinex or codein* or isocodein* or codipertussin or codyl or methylmorfine or 41 methylmorphine or morphin* or pentuss in All Fields in all products 42 #34 dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or Df 118 or 43 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 44 hydrocodin or nadein* or napacodin or novicodin or paracodein or paracodin or 45 paramol or parzone or rapacodin or remedacen or tiamon mono in All Fields in all 46 products 47 #35 (#13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22) 48 #36 (#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 49 OR #34) 50 #37 (#35 OR #36) 51 #38 abstain* or abstinen* or abus* or addict* or drug user* or dependen* or inject* drug* 52 or intoxicat* or misus* or overdos* or illicit use* or withdraw* in All Fields in all 53 products 54 #39 (#37 AND #38) 55 #40 (#12 OR #39) 56

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1 2 c. Database of Abstracts of Reviews of Effects – Wiley Interscience interface 3 4 #1 MeSH descriptor Amphetamine-Related Disorders, this term only in MeSH products 5 #2 MeSH descriptor Substance-Related Disorders, this term only in MeSH products 6 #3 MeSH descriptor Cocaine-Related Disorders, this term only in MeSH products 7 #4 MeSH descriptor Marijuana Abuse, this term only in MeSH products 8 #5 MeSH descriptor Neonatal Abstinence Syndrome, this term only in MeSH products 9 #6 MeSH descriptor Opioid-Related Disorders explode all trees in MeSH products 10 #7 MeSH descriptor Psychoses, Substance-Induced, this term only in MeSH products 11 #8 MeSH descriptor Substance Abuse, Intravenous, this term only in MeSH products 12 #9 MeSH descriptor Substance Withdrawal Syndrome, this term only in MeSH products 13 #10 (stimulant* or polydrug* or drug* or substance) near (abstain* or abstinen* or abus* 14 or addict* or dependen* or disorder* or intoxicat* or misuse* or over dos* or 15 overdos* or withdraw*) in All Fields in all products 16 #11 drug user* in All Fields in all products 17 #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) 18 #13 MeSH descriptor Amphetamines explode all trees in MeSH products 19 #14 MeSH descriptor Cannabis, this term only in MeSH products 20 #15 MeSH descriptor Central Nervous System Stimulants explode all trees in MeSH 21 products 22 #16 MeSH descriptor Cocaine explode all trees in MeSH products 23 #17 MeSH descriptor Heroin, this term only in MeSH products 24 #18 MeSH descriptor Methadone explode all trees in MeSH products 25 #19 MeSH descriptor Narcotics explode all trees in MeSH products 26 #20 MeSH descriptor Opium explode all trees in MeSH products 27 #21 amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed in 28 All Fields in all products 29 #22 Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* or 30 Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 31 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 32 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or 33 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 34 or Sydnocarb* or Sydnofen* or Tetrabenazine* in All Fields in all products 35 #23 Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 36 Ethylbarbituric Acid* or Allylglycine* or Amfonelic Acid* or Amiphenazole* or 37 Apomorphine* or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or 38 Cathinone* or Chloramphetamine* or Convulsant Agent* or Cropropamide* or 39 Crotetamide* or Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or 40 Dimefline* or Dimetamfetamine* or Doxapram* or Ephedrine* or Etamivan* or 41 Ethimizole* or Methylenedioxyamphetamine* in All Fields in all products 42 #24 Fencamfamin* or Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or 43 Homococaine* or Hydroxyamphetamine* or Lobeline* or Mazindol* or 44 Meclofenoxate* or Mefexamide* or Methamphetamine* or Methcathinone* or 45 Methylephedrine* or Methylphenidate* or Ethylamphetamine* or Nikethamide* or 46 Norcocaine* or Pemoline* or Pentetrazole* or Phenmetrazine* or Phentermine* or 47 Picrotoxin* or Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or 48 Pyrovalerone* or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 49 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* in All 50 Fields in all products 51 #25 analeptic* or psychostimulant* or stimulant* in All Fields in all products 52 #26 cannabis or hashish or marihuana or marijua* in All Fields in all products 53 #27 cocaine or crack in All Fields in all products 54 #28 diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 55 phenmetrazine or phendimetrazine or phenylpropanolamine in All Fields in all

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1 products 2 #29 heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack in All 3 Fields in all products 4 #30 methadone in All Fields in all products 5 #31 antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 6 trexan or vivitrex in All Fields in all products 7 #32 opiate* or opioid* or opium in All Fields in all products 8 #33 ardinex or codein* or isocodein* or codipertussin or codyl or methylmorfine or 9 methylmorphine or morphin* or pentuss in All Fields in all products 10 #34 dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or Df 118 or 11 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 12 hydrocodin or nadein* or napacodin or novicodin or paracodein or paracodin or 13 paramol or parzone or rapacodin or remedacen or tiamon mono in All Fields in all 14 products 15 #35 (#13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22) 16 #36 (#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 17 OR #34) 18 #37 (#35 OR #36) 19 #38 abstain* or abstinen* or abus* or addict* or drug user* or dependen* or inject* drug* 20 or intoxicat* or misus* or overdos* or illicit use* or withdraw* in All Fields in all 21 products 22 #39 (#37 AND #38) 23 #40 (#12 OR #39) 24 25 26 d. Cochrane Central Register of Controlled Trials — Wiley Interscience interface 27 28 #1 MeSH descriptor Amphetamine-Related Disorders, this term only in MeSH products 29 #2 MeSH descriptor Substance-Related Disorders, this term only in MeSH products 30 #3 MeSH descriptor Cocaine-Related Disorders, this term only in MeSH products 31 #4 MeSH descriptor Marijuana Abuse, this term only in MeSH products 32 #5 MeSH descriptor Neonatal Abstinence Syndrome, this term only in MeSH products 33 #6 MeSH descriptor Opioid-Related Disorders explode all trees in MeSH products 34 #7 MeSH descriptor Psychoses, Substance-Induced, this term only in MeSH products 35 #8 MeSH descriptor Substance Abuse, Intravenous, this term only in MeSH products 36 #9 MeSH descriptor Substance Withdrawal Syndrome, this term only in MeSH products 37 #10 (stimulant* or polydrug* or drug* or substance) near (abstain* or abstinen* or abus* 38 or addict* or dependen* or disorder* or intoxicat* or misuse* or over dos* or verdos* 39 or withdraw*) in All Fields in all products 40 #11 drug user* in All Fields in all products 41 #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) 42 #13 MeSH descriptor Amphetamines explode all trees in MeSH products 43 #14 MeSH descriptor Cannabis, this term only in MeSH products 44 #15 MeSH descriptor Central Nervous System Stimulants explode all trees in MeSH 45 products 46 #16 MeSH descriptor Cocaine explode all trees in MeSH products 47 #17 MeSH descriptor Heroin, this term only in MeSH products 48 #18 MeSH descriptor Methadone explode all trees in MeSH products 49 #19 MeSH descriptor Narcotics explode all trees in MeSH products 50 #20 MeSH descriptor Opium explode all trees in MeSH products 51 #21 amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed in 52 All Fields in all products 53 #22 Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* or 54 Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 55 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 56 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or

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1 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 2 or Sydnocarb* or Sydnofen* or Tetrabenazine* in All Fields in all products 3 #23 Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 4 Ethylbarbituric Acid* or Allylglycine* or Amfonelic Acid* or Amiphenazole* or 5 Apomorphine* or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or 6 Cathinone* or Chloramphetamine* or Convulsant Agent* or Cropropamide* or 7 Crotetamide* or Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or 8 Dimefline* or Dimetamfetamine* or Doxapram* or Ephedrine* or Etamivan* or 9 Ethimizole* or Methylenedioxyamphetamine* in All Fields in all products 10 #24 Fencamfamin* or Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or 11 Homococaine* or Hydroxyamphetamine* or Lobeline* or Mazindol* or 12 Meclofenoxate* or Mefexamide* or Methamphetamine* or Methcathinone* or 13 Methylephedrine* or Methylphenidate* or Ethylamphetamine* or Nikethamide* or 14 Norcocaine* or Pemoline* or Pentetrazole* or Phenmetrazine* or Phentermine* or 15 Picrotoxin* or Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or 16 Pyrovalerone* or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 17 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* in All 18 Fields in all products 19 #25 analeptic* or psychostimulant* or stimulant* in All Fields in all products 20 #26 cannabis or hashish or marihuana or marijua* in All Fields in all products 21 #27 cocaine or crack in All Fields in all products 22 #28 diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 23 phenmetrazine or phendimetrazine or phenylpropanolamine in All Fields in all 24 products 25 #29 heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack in All 26 Fields in all products 27 #30 methadone in All Fields in all products 28 #31 antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 29 trexan or vivitrex in All Fields in all products 30 #32 opiate* or opioid* or opium in All Fields in all products 31 #33 ardinex or codein* or isocodein* or codipertussin or codyl or methylmorfine or 32 methylmorphine or morphin* or pentuss in All Fields in all products 33 #34 dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or Df 118 34 or Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 35 hydrocodin or nadein* or napacodin or novicodin or paracodein or paracodin or 36 paramol or parzone or rapacodin or remedacen or tiamon mono in All Fields in all 37 products 38 #35 (#13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22) 39 #36 (#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 40 OR #34) 41 #37 (#35 OR #36) 42 #38 abstain* or abstinen* or abus* or addict* or drug user* or dependen* or inject* drug* 43 or intoxicat* or misus* or overdos* or illicit use* or withdraw* in All Fields in all 44 products 45 #39 (#37 AND #38) 46 #40 (#12 OR #39) 47 48 49 2. Systematic review search filters 50 51 a. MEDLINE, EMBASE, PsycINFO, CINAHL — Ovid interface 52 53 1 exp meta analysis/ or exp systematic review/ or exp literature review/ or exp 54 literature searching/ or exp cochrane library/ or exp review literature/ 55 2 ((systematic or quantitative or methodologic$) adj5 (overview$ or review$)).mp. 56 3 (metaanaly$ or meta analy$).mp.

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1 4 (research adj (review$ or integration)).mp. 2 5 reference list$.ab. 3 6 bibliograph$.ab. 4 7 published studies.ab. 5 8 relevant journals.ab. 6 9 selection criteria.ab. 7 10 (data adj (extraction or synthesis)).ab. 8 11 ((handsearch$3 or (hand or manual)) adj search$).tw. 9 12 ((mantel adj haenszel) or peto or dersimonian or der simonian).tw. 10 13 (fixed effect$ or random effect$).tw. 11 14 review$.pt,mp. and (bids or cochrane or index medicus or isi citation or medlars or 12 psyclit or psychlit or scisearch or science citation or web adj1 science).mp. 13 15 (systematic$ or meta$).pt. 14 16 or/1-15 15 16 17 3. Randomised controlled trials search filters 18 19 a. MEDLINE, EMBASE, PsycINFO, CINAHL — Ovid interface 20 21 1 exp clinical trials/ or exp clinical trial/ or exp controlled clinical trials/ 22 2 exp crossover procedure/ or exp cross over studies/ or exp crossover design/ 23 3 exp double blind procedure/ or exp double blind method/ or exp double blind 24 studies/ or exp single blind procedure/ or exp single blind method/ or exp single 25 blind studies/ 26 4 exp random allocation/ or exp randomization/ or exp random assignment/ or exp 27 random sample/ or exp random sampling/ 28 5 exp randomized controlled trials/ or exp randomized controlled trial/ 29 6 (clinical adj2 trial$).tw. 30 7 (crossover or cross over).tw. 31 8 (((single$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask$ or dummy)) or 32 (singleblind$ or doubleblind$ or trebleblind$)).tw. 33 9 (placebo$ or random$).mp. 34 10 (clinical trial$ or clinical control trial or random$).pt. 35 11 animals/ not (animals/ and human$.mp.) 36 12 animal$/ not (animal$/ and human$/) 37 13 (animal not (animal and human)).po. 38 14 (or/1-10) not (or/11-13) 39 40 41 Details of additional searches undertaken to support the development of this 42 guideline are available on request.

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1 Appendix 8: Clinical study data extraction form

2 Information about each study was entered into an Access database using 3 specially designed forms (see below for an example).

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

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1 2

3

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1 Appendix 9: Quality checklists for clinical studies and reviews 2 3 The methodological quality of each study was evaluated using dimensions 4 adapted from SIGN (Scottish Intercollegiate Guidelines Network, 2001). SIGN 5 originally adapted its quality criteria from checklists developed in Australia 6 (Liddel et al., 1996). Both groups reportedly undertook extensive development 7 and validation procedures when creating their quality criteria.

8 Quality Checklist for a Systematic Review or Meta-Analysis Study ID: Guideline topic: Key question no: Checklist completed by: SECTION 1: INTERNAL VALIDITY In a well-conducted systematic review: In this study this criterion is: (Circle one option for each question) 1.1 The study addresses an appropriate Well covered Not addressed and clearly focused question. Adequately addressed Not reported Poorly addressed Not applicable

1.2 A description of the methodology Well covered Not addressed used is included. Adequately addressed Not reported Poorly addressed Not applicable

1.3 The literature search is sufficiently Well covered Not addressed rigorous to identify all the relevant Adequately addressed Not reported studies. Poorly addressed Not applicable

1.4 Study quality is assessed and taken Well covered Not addressed into account. Adequately addressed Not reported Poorly addressed Not applicable

1.5 There are enough similarities Well covered Not addressed between the studies selected to make Adequately addressed Not reported combining them reasonable. Poorly addressed Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? Code ++, + or –

9 10 Notes on the use of the methodology checklist: systematic reviews and 11 meta-analyses

12 Section 1 identifies the study and asks a series of questions aimed at 13 establishing the internal validity of the study under review — that is, making 14 sure that it has been carried out carefully and that the outcomes are likely to 15 be attributable to the intervention being investigated. Each question covers an 16 aspect of methodology that research has shown makes a significant difference 17 to the conclusions of a study.

18

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1 For each question in this section, one of the following should be used to 2 indicate how well it has been addressed in the review: 3 4 • well covered

5 • adequately addressed

6 • poorly addressed

7 • not addressed (that is, not mentioned or indicates that this aspect of 8 study design was ignored)

9 • not reported (that is, mentioned but insufficient detail to allow 10 assessment to be made)

11 • not applicable.

12 13 1.1 The study addresses an appropriate and clearly focused question 14 Unless a clear and well-defined question is specified in the report of the 15 review, it will be difficult to assess how well it has met its objectives or how 16 relevant it is to the question to be answered on the basis of the conclusions. 17 18 1.2 A description of the methodology used is included 19 One of the key distinctions between a systematic review and a general review 20 is the systematic methodology used. A systematic review should include a 21 detailed description of the methods used to identify and evaluate individual 22 studies. If this description is not present, it is not possible to make a thorough 23 evaluation of the quality of the review, and it should be rejected as a source of 24 level-1 evidence (though it may be useable as level-4 evidence, if no better 25 evidence can be found). 26 27 1.3 The literature search is sufficiently rigorous to identify all the 28 relevant studies 29 A systematic review based on a limited literature search — for example, one 30 limited to Medline only — is likely to be heavily biased. A well-conducted 31 review should as a minimum look at Embase and Medline and, from the late 32 1990s onward, the Cochrane Library. Any indication that hand searching of 33 key journals, or follow-up of reference lists of included studies, were carried 34 out in addition to electronic database searches can normally be taken as 35 evidence of a well-conducted review. 36 37 1.4 Study quality is assessed and taken into account 38 A well-conducted systematic review should have used clear criteria to assess 39 whether individual studies had been well conducted before deciding whether 40 to include or exclude them. If there is no indication of such an assessment, the 41 review should be rejected as a source of level-1 evidence. If details of the

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1 assessment are poor, or the methods are considered to be inadequate, the 2 quality of the review should be downgraded. In either case, it may be 3 worthwhile obtaining and evaluating the individual studies as part of the 4 review being conducted for this guideline. 5 6 1.5 There are enough similarities between the studies selected to make 7 combining them reasonable 8 Studies covered by a systematic review should be selected using clear 9 inclusion criteria (see question 1.4 above). These criteria should include, either 10 implicitly or explicitly, the question of whether the selected studies can 11 legitimately be compared. It should be clearly ascertained, for example, that 12 the populations covered by the studies are comparable, that the methods used 13 in the investigations are the same, that the outcome measures are comparable 14 and the variability in effect sizes between studies is not greater than would be 15 expected by chance alone. 16 17 Section 2 relates to the overall assessment of the paper. It starts by rating the 18 methodological quality of the study, based on the responses in Section 1 and 19 using the following coding system: 20 ++ All or most of the criteria have been fulfilled. Where they have not been fulfilled, the conclusions of the study or review are thought very unlikely to alter. + Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. – Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter. 21 22 Quality Checklist for an RCT Study ID: Guideline topic: Key question no: Checklist completed by: SECTION 1: INTERNAL VALIDITY In a well-conducted RCT study: In this study this criterion is: (Circle one option for each question) 1.1 The study addresses an appropriate and Well covered Not addressed clearly focused question. Adequately addressed Not reported Poorly addressed Not applicable

1.2 The assignment of subjects to treatment Well covered Not addressed groups is randomised. Adequately addressed Not reported Poorly addressed Not applicable 1.3 An adequate concealment method is Well covered Not addressed used. Adequately addressed Not reported Poorly addressed Not applicable

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1.4 Subjects and investigators are kept ‘blind’ Well covered Not addressed about treatment allocation. Adequately addressed Not reported Poorly addressed Not applicable

1.5 The treatment and control groups are Well covered Not addressed similar at the start of the trial. Adequately addressed Not reported Poorly addressed Not applicable 1.6 The only difference between groups is Well covered Not addressed the treatment under investigation. Adequately addressed Not reported Poorly addressed Not applicable 1.7 All relevant outcomes are measured in a Well covered Not addressed standard, valid and reliable way. Adequately addressed Not reported Poorly addressed Not applicable 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the Well covered Not addressed groups to which they were randomly Adequately addressed Not reported allocated (often referred to as intention- Poorly addressed Not applicable to-treat analysis).

1.10 Where the study is carried out at more Well covered Not addressed than one site, results are comparable for Adequately addressed Not reported all sites. Poorly addressed Not applicable SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? Code ++, + or – 1 2 Notes on the use of the methodology checklist: randomised controlled trials 3 4 Section 1 identifies the study and asks a series of questions aimed at 5 establishing the internal validity of the study under review — that is, making 6 sure that it has been carried out carefully and that the outcomes are likely to be 7 attributable to the intervention being investigated. Each question covers an 8 aspect of methodology that research has shown makes a significant difference 9 to the conclusions of a study. 10 11 For each question in this section, one of the following should be used to 12 indicate how well it has been addressed in the review: 13 14 • well covered

15 • adequately addressed

16 • poorly addressed

17 • not addressed (that is, not mentioned or indicates that this aspect of 18 study design was ignored)

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1 • not reported (that is, mentioned but insufficient detail to allow 2 assessment to be made)

3 • not applicable.

4 5 1.1 The study addresses an appropriate and clearly focused question 6 Unless a clear and well-defined question is specified, it will be difficult to assess 7 how well the study has met its objectives or how relevant it is to the question to 8 be answered on the basis of its conclusions. 9 10 1.2 The assignment of subjects to treatment groups is randomised 11 Random allocation of patients to receive one or other of the treatments under 12 investigation, or to receive either treatment or placebo, is fundamental to this 13 type of study. If there is no indication of randomisation, the study should be 14 rejected. If the description of randomisation is poor, or the process used is not 15 truly random (for example, allocation by date or alternating between one group 16 and another) or can otherwise be seen as flawed, the study should be given a 17 lower quality rating. 18 19 1.3 An adequate concealment method is used 20 Research has shown that where allocation concealment is inadequate, 21 investigators can overestimate the effect of interventions by up to 40%. 22 Centralised allocation, computerised allocation systems or the use of coded 23 identical containers would all be regarded as adequate methods of concealment 24 and may be taken as indicators of a well-conducted study. If the method of 25 concealment used is regarded as poor, or relatively easy to subvert, the study 26 must be given a lower quality rating, and can be rejected if the concealment 27 method is seen as inadequate. 28 29 1.4 Subjects and investigators are kept ‘blind’ about treatment allocation 30 Blinding can be carried out up to three levels. In single-blind studies, patients 31 are unaware of which treatment they are receiving; in double-blind studies the 32 doctor and the patient are unaware of which treatment the patient is receiving; 33 in triple-blind studies patients, healthcare providers and those conducting the 34 analysis are unaware of which patients receive which treatment. The higher the 35 level of blinding, the lower the risk of bias in the study. 36 37 1.5 The treatment and control groups are similar at the start of the trial 38 Patients selected for inclusion in a trial should be as similar as possible, in order 39 to eliminate any possible bias. The study should report any significant 40 differences in the composition of the study groups in relation to gender mix, 41 age, stage of disease (if appropriate), social background, ethnic origin or 42 comorbid conditions. These factors may be covered by inclusion and exclusion 43 criteria, rather than being reported directly. Failure to address this question, or 44 the use of inappropriate groups, should lead to the study being downgraded. 45

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1 1.6 The only difference between groups is the treatment under 2 investigation 3 If some patients receive additional treatment, even if of a minor nature or 4 consisting of advice and counselling rather than a physical intervention, this 5 treatment is a potential confounding factor that may invalidate the results. If 6 groups are not treated equally, the study should be rejected unless no other 7 evidence is available. If the study is used as evidence, it should be treated with 8 caution and given a low quality rating. 9 10 1.7 All relevant outcomes are measured in a standard, valid and reliable 11 way 12 If some significant clinical outcomes have been ignored, or not adequately taken 13 into account, the study should be downgraded. It should also be downgraded if 14 the measures used are regarded as being doubtful in any way or applied 15 inconsistently. 16 17 1.8 What percentage of the individuals or clusters recruited into each 18 treatment arm of the study dropped out before the study was 19 completed? 20 The number of patients that drop out of a study should give concern if the 21 number is very high. Conventionally, a 20% drop-out rate is regarded as 22 acceptable, but this may vary. Some regard should be paid to why patients drop 23 out, as well as how many. It should be noted that the drop-out rate may be 24 expected to be higher in studies conducted over a long period of time. A higher 25 drop-out rate will normally lead to downgrading, rather than rejection, of a 26 study. 27 28 1.9 All the subjects are analysed in the groups to which they were 29 randomly allocated (often referred to as intention-to-treat analysis) 30 In practice, it is rarely the case that all patients allocated to the intervention 31 group receive the intervention throughout the trial, or that all those in the 32 comparison group do not. Patients may refuse treatment, or contraindications 33 arise that lead them to be switched to the other group. If the comparability of 34 groups through randomisation is to be maintained, however, patient outcomes 35 must be analysed according to the group to which they were originally 36 allocated, irrespective of the treatment they actually received. (This is known as 37 intention-to-treat analysis.) If it is clear that analysis is not on an intention-to- 38 treat basis, the study may be rejected. If there is little other evidence available, 39 the study may be included but should be evaluated as if it were a non- 40 randomised cohort study. 41 42 1.10 Where the study is carried out at more than one site, results are 43 comparable for all sites 44 In multi-site studies, confidence in the results should be increased if it can be 45 shown that similar results have been obtained at the different participating 46 centres. 47

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1 Section 2 relates to the overall assessment of the paper. It starts by rating the 2 methodological quality of the study, based on the responses in Section 1 and 3 using the following coding system: 4 ++ All or most of the criteria have been fulfilled. Where they have not been fulfilled, the conclusions of the study or review are thought very unlikely to alter. + Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. – Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter. 5 6 Quality Checklist for a Cohort Study* Study ID: Relevant questions:

Guideline topic:

Checklist completed by:

SECTION 1: INTERNAL VALIDITY In a well conducted cohort study: In this study the criterion is: (Circle one option for each question) 1.1 The study addresses an appropriate and Well covered Not addressed clearly focused question. Adequately addressed Not reported Poorly addressed Not applicable SELECTION OF SUBJECTS 1.2 The two groups being studied are selected Well covered Not addressed from source populations that are comparable Adequately addressed Not reported in all respects other than the factor under Poorly addressed Not applicable investigation. 1.3 The study indicates how many of the people Well covered Not addressed asked to take part did so, in each of the Adequately addressed Not reported groups being studied. Poorly addressed Not applicable 1.4 The likelihood that some eligible subjects Well covered Not addressed might have the outcome at the time of Adequately addressed Not reported enrolment is assessed and taken into account Poorly addressed Not applicable in the analysis. 1.5 What percentage of individuals or clusters recruited into each arm of the study dropped out before the study was completed?

1.6 Comparison is made between full Well covered Not addressed participants and those lost to follow-up, by Adequately addressed Not reported exposure status. Poorly addressed Not applicable ASSESSMENT 1.7 The outcomes are clearly defined. Well covered Not addressed Adequately addressed Not reported Poorly addressed Not applicable 1.8 The assessment of outcome is made blind to Well covered Not addressed exposure status. Adequately addressed Not reported Poorly addressed Not applicable

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1.9 Where blinding was not possible, there is Well covered Not addressed some recognition that knowledge of exposure Adequately addressed Not reported status could have influenced the assessment Poorly addressed Not applicable of outcome. 1.10 The measure of assessment of exposure is Well covered Not addressed reliable. Adequately addressed Not reported Poorly addressed Not applicable 1.11 Evidence from other sources is used to Well covered Not addressed demonstrate that the method of outcome Adequately addressed Not reported assessment is valid and reliable. Poorly addressed Not applicable 1.12 Exposure level or prognostic factor is Well covered Not addressed assessed more than once. Adequately addressed Not reported Poorly addressed Not applicable CONFOUNDING 1.13 The main potential confounders are identified Well covered Not addressed and taken into account in the design and Adequately addressed Not reported analysis. Poorly addressed Not applicable STATISTICAL ANALYSIS 1.14 Have confidence intervals been provided?

SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise the risk of bias or confounding, and to establish a causal relationship between exposure and effect? Code ++, + or – 1 *A cohort study can be defined as a retrospective or prospective follow-up study. Groups of 2 individuals are defined on the basis of the presence or absence of exposure to a suspected risk 3 factor or intervention. This checklist is not appropriate for assessing uncontrolled studies (for 4 example, a case series where there is no comparison [control] group of patients). 5 6 Notes on the use of the methodology checklist: cohort studies 7 8 The studies covered by this checklist are designed to answer questions of the 9 type ‘What are the effects of this exposure?’ It relates to studies that compare 10 a group of people with a particular exposure with another group who either 11 have not had the exposure or have a different level of exposure. Cohort 12 studies may be prospective (where the exposure is defined and subjects 13 selected before outcomes occur) or retrospective (where exposure is assessed 14 after the outcome is known, usually by the examination of medical records). 15 Retrospective studies are generally regarded as a weaker design, and should 16 not receive a 2++ rating. 17 18 Section 1 identifies the study and asks a series of questions aimed at 19 establishing the internal validity of the study under review —that is, making 20 sure that it has been carried out carefully, and that the outcomes are likely to 21 be attributable to the intervention being investigated. Each question covers an 22 aspect of methodology that has been shown to make a significant difference to 23 the conclusions of a study. 24 25 Because of the potential complexity and subtleties of the design of this type of 26 study, there are comparatively few criteria that automatically rule out use of a

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1 study as evidence. It is more a matter of increasing confidence in the 2 likelihood of a causal relationship existing between exposure and outcome by 3 identifying how many aspects of good study design are present and how well 4 they have been tackled. A study that fails to address or report on more than 5 one or two of the questions considered below should almost certainly be 6 rejected. 7 8 For each question in this section, one of the following should be used to 9 indicate how well it has been addressed in the review: 10 11 • well covered

12 • adequately addressed

13 • poorly addressed

14 • not addressed (that is, not mentioned or indicates that this aspect of 15 study design was ignored)

16 • not reported (that is, mentioned but insufficient detail to allow 17 assessment to be made)

18 • not applicable

19 20 1.1 The study addresses an appropriate and clearly focused question 21 Unless a clear and well-defined question is specified, it will be difficult to 22 assess how well the study has met its objectives or how relevant it is to the 23 question to be answered on the basis of its conclusions. 24 25 1.2 The two groups being studied are selected from source populations 26 that are comparable in all respects other than the factor under 27 investigation 28 Study participants may be selected from the target population (all individuals 29 to which the results of the study could be applied), the source population (a 30 defined subset of the target population from which participants are selected) 31 or from a pool of eligible subjects (a clearly defined and counted group 32 selected from the source population). It is important that the two groups 33 selected for comparison are as similar as possible in all characteristics except 34 for their exposure status or the presence of specific prognostic factors or 35 prognostic markers relevant to the study in question. If the study does not 36 include clear definitions of the source populations and eligibility criteria for 37 participants, it should be rejected. 38 39 1.3 The study indicates how many of the people asked to take part did so 40 in each of the groups being studied

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1 This question relates to what is known as the participation rate, defined as the 2 number of study participants divided by the number of eligible subjects. This 3 should be calculated separately for each branch of the study. A large 4 difference in participation rate between the two arms of the study indicates 5 that a significant degree of selection bias may be present, and the study 6 results should be treated with considerable caution. 7 8 1.4 The likelihood that some eligible subjects might have the outcome at 9 the time of enrolment is assessed and taken into account in the 10 analysis 11 If some of the eligible subjects, particularly those in the unexposed group, 12 already have the outcome at the start of the trial, the final result will be 13 biased. A well-conducted study will attempt to estimate the likelihood of this 14 occurring and take it into account in the analysis through the use of sensitivity 15 studies or other methods. 16 17 1.5 What percentage of individuals or clusters recruited into each arm of 18 the study dropped out before the study was completed? 19 The number of patients that drop out of a study should give concern if the 20 number is very high. Conventionally, a 20% drop-out rate is regarded as 21 acceptable, but in observational studies conducted over a lengthy period of 22 time a higher drop-out rate is to be expected. A decision on whether to 23 downgrade or reject a study because of a high drop-out rate is a matter of 24 judgement based on the reasons why people drop out and whether drop-out 25 rates are comparable in the exposed and unexposed groups. Reporting of 26 efforts to follow up participants that drop out may be regarded as an 27 indicator of a well-conducted study. 28 29 1.6 Comparison is made between full participants and those lost to 30 follow-up by exposure status 31 For valid study results, it is essential that the study participants are truly 32 representative of the source population. It is always possible that participants 33 who drop out of the study will differ in some significant way from those who 34 remain part of the study throughout. A well-conducted study will attempt to 35 identify any such differences between full and partial participants in both the 36 exposed and unexposed groups. Any indication that differences exist should 37 lead to the study results being treated with caution. 38 39 1.7 The outcomes are clearly defined 40 Once enrolled in the study, participants should be followed until specified 41 end points or outcomes are reached. In a study of the effect of exercise on the 42 death rates from heart disease in middle-aged men, for example, participants 43 might be followed up until death, reaching a predefined age or until 44 completion of the study. If outcomes and the criteria used for measuring them 45 are not clearly defined, the study should be rejected. 46 47 1.8 The assessment of outcome is made blind to exposure status

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1 If the assessor is blinded to which participants received the exposure, and 2 which did not, the prospects of unbiased results are significantly increased. 3 Studies in which this is done should be rated more highly than those where it 4 is not done or not done adequately. 5 6 1.9 Where blinding was not possible, there is some recognition that 7 knowledge of exposure status could have influenced the assessment 8 of outcome 9 Blinding is not possible in many cohort studies. In order to assess the extent of 10 any bias that may be present, it may be helpful to compare process measures 11 used on the participant groups — for example, frequency of observations, 12 who carried out the observations and the degree of detail and completeness of 13 observations. If these process measures are comparable between the groups, 14 the results may be regarded with more confidence. 15 16 1.10 The measure of assessment of exposure is reliable 17 A well-conducted study should indicate how the degree of exposure or 18 presence of prognostic factors or markers was assessed. Whatever measures 19 are used must be sufficient to establish clearly that participants have or have 20 not received the exposure under investigation and the extent of such 21 exposure, or that they do or do not possess a particular prognostic marker or 22 factor. Clearly described, reliable measures should increase the confidence in 23 the quality of the study. 24 25 1.11 Evidence from other sources is used to demonstrate that the method 26 of outcome assessment is valid and reliable 27 The inclusion of evidence from other sources or previous studies that 28 demonstrate the validity and reliability of the assessment methods used 29 should further increase confidence in study quality. 30 31 1.12 Exposure level or prognostic factor is assessed more than once 32 Confidence in data quality should be increased if exposure level or the 33 presence of prognostic factors is measured more than once. Independent 34 assessment by more than one investigator is preferable. 35 36 1.13 The main potential confounders are identified and taken into 37 account in the design and analysis 38 Confounding is the distortion of a link between exposure and outcome by 39 another factor that is associated with both exposure and outcome. The 40 possible presence of confounding factors is one of the principal reasons why 41 observational studies are not more highly rated as a source of evidence. The 42 report of the study should indicate which potential confounders have been 43 considered and how they have been assessed or allowed for in the analysis. 44 Clinical judgement should be applied to consider whether all likely 45 confounders have been considered. If the measures used to address 46 confounding are considered inadequate, the study should be downgraded or 47 rejected, depending on how serious the risk of confounding is considered to

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1 be. A study that does not address the possibility of confounding should be 2 rejected. 3 4 1.14 Have confidence intervals been provided? 5 Confidence limits are the preferred method for indicating the precision of 6 statistical results and can be used to differentiate between an inconclusive 7 study and a study that shows no effect. Studies that report a single value with 8 no assessment of precision should be treated with caution. 9 10 Section 2 relates to the overall assessment of the paper. It starts by rating the 11 methodological quality of the study, based on the responses in Section 1 and 12 using the following coding system: 13 ++ All or most of the criteria have been fulfilled. Where they have not been fulfilled, the conclusions of the study or review are thought very unlikely to alter. + Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. – Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter. 14

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1 Appendix 10: Search strategies for the identification of health economics 2 evidence

3 Search strategies for the identification of health economics and quality-of-life 4 studies 5 6 1 General search filters 7 8 Drug misuse 9 10 a. MEDLINE, EMBASE, PsycINFO, CINAHL — Ovid interface 11 12 1 Amphetamine-related disorders/ 13 2 Cannabis addiction/ or Marijuana abuse/ 14 3 Cocaine dependence/ or Cocaine-related disorders/ 15 4 Heroin addiction/ 16 5 exp Narcotic dependence/ 17 6 Opiate addiction/ or exp Opioid-related disorders/ 18 7 Drug abuse/ or Drug abuse pattern/ or Drug addiction/ or Drug misuse/ or Drug 19 overdoses/ or Intravenous drug abuse/ or Substance abuse/ or Substance-related 20 disorders/ or "Substance use disorders"/ 21 8 Drug dependence/ or Drug dependency/ or Substance dependence/ 22 9 Multiple drug abuse/ or Polydrug abuse/ 23 10 Neonatal abstinence syndrome/ 24 11 Psychoses, substance-induced/ 25 12 Substance abuse, intravenous/ 26 13 Substance abuse, perinatal/ 27 14 Substance withdrawal syndrome/ 28 15 (((stimulant$ or polydrug$ or drug$1 or substance) adj3 (abstain$ or abstinen$ or 29 abus$ or addict$ or (excessive adj use$) or dependen$ or disorder$ or intoxicat$ or 30 misuse$ or over dos$ or overdos$ or (use$ adj (disorder$ or illicit)) or withdraw$)) or 31 (drug$1 adj user$)).tw. 32 16 or/1-15 33 17 exp amphetamines/ or exp amphetamine derivative/ 34 18 exp Cannabis/ 35 19 exp CNS stimulating drugs/ or exp central nervous system stimulants/ or exp 36 central stimulant agent/ or exp psychostimulant agent/ 37 20 exp Cocaine/ 38 21 Diamorphine/ or exp Heroin/ 39 22 exp Methadone/ 40 23 exp Narcotic agent/ or exp Narcotics/ 41 24 Naltrexone$.sh. 42 25 exp Opiate/ or exp Opiates/ or exp Opium/ 43 26 (amphetamine$ or crank or dextroamphetamine$ or methamphetamine$ or speed or 44 uppers).tw. 45 27 (Adrafinil$ or Amphetaminil$ or Butanamine$ or Benzphetamine$ or Bromantan$ or 46 Chloramphetamine$ or Deanol$ or Dexamphetamine$ or Dexmethylphenidate$ or 47 Dimethoxy or Methylamphetamine$ or Hydroxyamphetamine$ or Lefetamine$ or 48 Meclofenoxate$ or Mefexamide$ or Methcathinone$ or Methoxyamphetamine$ or 49 Methylamphetamine$ or Methylphenidate$ or Modafinil$ or Pemoline$ or icamilon$ 50 or Sydnocarb$ or Sydnofen$ or Tetrabenazine$).mp. 51 28 (Butanamine$ or Methylamphetamine$ or Methylenedioxymethamphetamine$ or 52 Ethylbarbituric Acid$ or Allylglycine$ or Amfonelic Acid$ or Amiphenazole$ or

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1 Apomorphine$ or Bemegride$ or Benzphetamine$ or Brucine$ or Carphedon$ or 2 Cathinone$ or Chloramphetamine$ or Convulsant Agent or Cropropamide$ or 3 Crotetamide$ or Dexamphetamine$ or Dexoxadrol$ or Dextroamphetamine$ or 4 Dimefline$ or Dimetamfetamine$ or Doxapram$ or Ephedrine$ or Etamivan$ or 5 Ethimizole$ or Methylenedioxyamphetamine$ or Fencamfamin$ or Fenetylline$ or 6 Flurothyl$ or Fominoben$ or Harmaline$ or Homococaine$ or 7 Hydroxyamphetamine$ or Lobeline$ or Mazindol$ or Meclofenoxate$ or 8 Mefexamide$ or Methamphetamine$ or Methcathinone$ or Methylephedrine$ or 9 Methylphenidate$ or Ethylamphetamine$ or Nikethamide$ or Norcocaine$ or 10 Pemoline$ or Pentetrazole$ or Phenmetrazine$ or Phentermine$ or Picrotoxin$ or 11 Pipradol$ or Prethcamide$ or Prolintane$ or Pseudoephedrine$ or Pyrovalerone$ or 12 Racephedrine$ or Strychnine$ or Butylbicycloorthobenzoate$ or 13 Butylbicyclophosphorothioate$ or Tetramethylsuccinimide$ or Theodrenaline$).mp. 14 29 (analeptic$ or psychostimulant$ or stimulant$).tw. 15 30 (cannabis or hashish or marihuana or marijua$).mp. 16 31 (cocaine or crack).tw. 17 32 (diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 18 phenmetrazine or phendimetrazine or phenylpropanolamine).mp. 19 33 (heroin or diacetylmorphine or diamorphine or morphin$ or morfin$ or smack).tw. 20 34 methadone.tw. 21 35 (antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 22 trexan or vivitrex).tw. 23 36 (opiate$ or opioid$ or opium).mp. 24 37 (ardinex or codein$ or isocodein$ or codipertussin or codyl or methyl morfine or 25 methylmorfine or methyl morphine or methylmorphine or morphine 3 methyl ether 26 or morphine methyl ether or morphine monomethyl ether or pentuss or trans codeine 27 or 467-15-2).mp,rn. 28 38 (dihydrocodeine or codhydrin$ or codicontin or cohydrin or dehacodin or Df 118 or 29 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 30 hydrocodin or nadein$ or napacodin or novicodin or paracodein or paracodin or 31 paramol or parzone or rapacodin or remedacen or tiamon mono or 5965-13-9).mp,rn. 32 39 or/17-38 33 40 (abstain$ or abstinen$ or abus$ or addict$ or (drug adj use$) or (excessive adj use$) or 34 dependen$ or (inject$ adj2 drug$) or intoxicat$ or misus$ or over dos$ or overdos$ or 35 (use$ adj (disorder$ or illicit)) or withdraw$).mp. 36 41 and/39-40 37 42 or/16,41 38 39 40 b. NHS Economic Evaluation Database — Wiley Interscience interface 41 42 #1 MeSH descriptor Amphetamine-Related Disorders, this term only in MeSH products 43 #2 MeSH descriptor Substance-Related Disorders, this term only in MeSH products 44 #3 MeSH descriptor Cocaine-Related Disorders, this term only in MeSH products 45 #4 MeSH descriptor Marijuana Abuse, this term only in MeSH products 46 #5 MeSH descriptor Neonatal Abstinence Syndrome, this term only in MeSH products 47 #6 MeSH descriptor Opioid-Related Disorders explode all trees in MeSH products 48 #7 MeSH descriptor Psychoses, Substance-Induced, this term only in MeSH products 49 #8 MeSH descriptor Substance Abuse, Intravenous, this term only in MeSH products 50 #9 MeSH descriptor Substance Withdrawal Syndrome, this term only in MeSH products 51 #10 (stimulant* or polydrug* or drug* or substance) near (abstain* or abstinen* or abus* 52 or addict* or dependen* or disorder* or intoxicat* or misuse* or over dos* or overdos* 53 or withdraw*) in All Fields in all products 54 #11 drug user* in All Fields in all products 55 #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) 56 #13 MeSH descriptor Amphetamines explode all trees in MeSH products

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1 #14 MeSH descriptor Cannabis, this term only in MeSH products 2 #15 MeSH descriptor Central Nervous System Stimulants explode all trees in MeSH 3 products 4 #16 MeSH descriptor Cocaine explode all trees in MeSH products 5 #17 MeSH descriptor Heroin, this term only in MeSH products 6 #18 MeSH descriptor Methadone explode all trees in MeSH products 7 #19 MeSH descriptor Narcotics explode all trees in MeSH products 8 #20 MeSH descriptor Opium explode all trees in MeSH products 9 #21 amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed in 10 All Fields in all products 11 #22 Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* or 12 Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 13 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 14 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or 15 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 16 or Sydnocarb* or Sydnofen* or Tetrabenazine* in All Fields in all products 17 #23 Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 18 Ethylbarbituric Acid* or Allylglycine* or Amfonelic Acid* or Amiphenazole* or 19 Apomorphine* or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or 20 Cathinone* or Chloramphetamine* or Convulsant Agent* or Cropropamide* or 21 Crotetamide* or Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or 22 Dimefline* or Dimetamfetamine* or Doxapram* or Ephedrine* or Etamivan* or 23 Ethimizole* or Methylenedioxyamphetamine* in All Fields in all products 24 #24 Fencamfamin* or Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or 25 Homococaine* or Hydroxyamphetamine* or Lobeline* or Mazindol* or 26 Meclofenoxate* or Mefexamide* or Methamphetamine* or Methcathinone* or 27 Methylephedrine* or Methylphenidate* or Ethylamphetamine* or Nikethamide* or 28 Norcocaine* or Pemoline* or Pentetrazole* or Phenmetrazine* or Phentermine* or 29 Picrotoxin* or Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or 30 Pyrovalerone* or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 31 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* in All 32 Fields in all products 33 #25 analeptic* or psychostimulant* or stimulant* in All Fields in all products 34 #26 cannabis or hashish or marihuana or marijua* in All Fields in all products 35 #27 cocaine or crack in All Fields in all products 36 #28 diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 37 phenmetrazine or phendimetrazine or phenylpropanolamine in All Fields in all 38 products 39 #29 heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack in All 40 Fields in all products 41 #30 methadone in All Fields in all products 42 #31 antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 43 trexan or vivitrex in All Fields in all products 44 #32 opiate* or opioid* or opium in All Fields in all products 45 #33 ardinex or codein* or isocodein* or codipertussin or codyl or methylmorfine or 46 methylmorphine or morphin* or pentuss in All Fields in all products 47 #34 dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or Df 118 or 48 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 49 hydrocodin or nadein* or napacodin or novicodin or paracodein or paracodin or 50 paramol or parzone or rapacodin or remedacen or tiamon mono in All Fields in all 51 products 52 #35 (#13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22) 53 #36 (#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 54 OR #34) 55 #37 (#35 OR #36) 56 #38 abstain* or abstinen* or abus* or addict* or drug user* or dependen* or inject* drug*

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1 or intoxicat* or misus* or overdos* or illicit use* or withdraw* in All Fields in all 2 products 3 #39 (#37 AND #38) 4 #40 (#12 OR #39) 5 6 7 c. Health Technology Assessment Database — Wiley Interscience interface 8 9 #1 MeSH descriptor Amphetamine-Related Disorders, this term only in MeSH products 10 #2 MeSH descriptor Substance-Related Disorders, this term only in MeSH products 11 #3 MeSH descriptor Cocaine-Related Disorders, this term only in MeSH products 12 #4 MeSH descriptor Marijuana Abuse, this term only in MeSH products 13 #5 MeSH descriptor Neonatal Abstinence Syndrome, this term only in MeSH products 14 #6 MeSH descriptor Opioid-Related Disorders explode all trees in MeSH products 15 #7 MeSH descriptor Psychoses, Substance-Induced, this term only in MeSH products 16 #8 MeSH descriptor Substance Abuse, Intravenous, this term only in MeSH products 17 #9 MeSH descriptor Substance Withdrawal Syndrome, this term only in MeSH products 18 #10 (stimulant* or polydrug* or drug* or substance) near (abstain* or abstinen* or abus* 19 or addict* or dependen* or disorder* or intoxicat* or misuse* or over dos* or overdos* 20 or withdraw*) in All Fields in all products 21 #11 drug user* in All Fields in all products 22 #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) 23 #13 MeSH descriptor Amphetamines explode all trees in MeSH products 24 #14 MeSH descriptor Cannabis, this term only in MeSH products 25 #15 MeSH descriptor Central Nervous System Stimulants explode all trees in MeSH 26 products 27 #16 MeSH descriptor Cocaine explode all trees in MeSH products 28 #17 MeSH descriptor Heroin, this term only in MeSH products 29 #18 MeSH descriptor Methadone explode all trees in MeSH products 30 #19 MeSH descriptor Narcotics explode all trees in MeSH products 31 #20 MeSH descriptor Opium explode all trees in MeSH products 32 #21 amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed in 33 All Fields in all products 34 #22 Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* or 35 Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 36 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 37 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or 38 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 39 or Sydnocarb* or Sydnofen* or Tetrabenazine* in All Fields in all products 40 #23 Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 41 Ethylbarbituric Acid* or Allylglycine* or Amfonelic Acid* or Amiphenazole* or 42 Apomorphine* or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or 43 Cathinone* or Chloramphetamine* or Convulsant Agent* or Cropropamide* or 44 Crotetamide* or Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or 45 Dimefline* or Dimetamfetamine* or Doxapram* or Ephedrine* or Etamivan* or 46 Ethimizole* or Methylenedioxyamphetamine* in All Fields in all products 47 #24 Fencamfamin* or Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or 48 Homococaine* or Hydroxyamphetamine* or Lobeline* or Mazindol* or 49 Meclofenoxate* or Mefexamide* or Methamphetamine* or Methcathinone* or 50 Methylephedrine* or Methylphenidate* or Ethylamphetamine* or Nikethamide* or 51 Norcocaine* or Pemoline* or Pentetrazole* or Phenmetrazine* or Phentermine* or 52 Picrotoxin* or Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or 53 Pyrovalerone* or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 54 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* in All 55 Fields in all products 56 #25 analeptic* or psychostimulant* or stimulant* in All Fields in all products

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1 #26 cannabis or hashish or marihuana or marijua* in All Fields in all products 2 #27 cocaine or crack in All Fields in all products 3 #28 diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 4 phenmetrazine or phendimetrazine or phenylpropanolamine in All Fields in all 5 products 6 #29 heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack in All 7 Fields in all products 8 #30 methadone in All Fields in all products 9 #31 antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 10 trexan or vivitrex in All Fields in all products 11 #32 opiate* or opioid* or opium in All Fields in all products 12 #33 ardinex or codein* or isocodein* or codipertussin or codyl or methylmorfine or 13 methylmorphine or morphin* or pentuss in All Fields in all products 14 #34 dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or Df 118 or 15 Df118 or didrate or dihydrin or dihydroneopine or drocode or hydrocodeine or 16 hydrocodin or nadein* or napacodin or novicodin or paracodein or paracodin or 17 paramol or parzone or rapacodin or remedacen or tiamon mono in All Fields in all 18 products 19 #35 (#13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22) 20 #36 (#23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 21 OR #34) 22 #37 (#35 OR #36) 23 #38 abstain* or abstinen* or abus* or addict* or drug user* or dependen* or inject* drug* 24 or intoxicat* or misus* or overdos* or illicit use* or withdraw* in All Fields in all 25 products 26 #39 (#37 AND #38) 27 #40 (#12 OR #39) 28 29 30 d. OHE EED — Clarinet interface 31 32 1 AX=(stimulant* or polydrug* or drug* or substance) and (abstain* or abstinen* or 33 abus* or addict* or dependen* or disorder* or intoxicat* or misuse* or overdos* or 34 withdraw*) 35 2 AX='illicit use' or 'drug use' or 'drug user' or 'drug users' 36 3 AX=amphetamine* or crank or dextroamphetamine* or methamphetamine* or speed 37 or uppers 38 4 AX=Adrafinil* or Amphetaminil* or Butanamine* or Benzphetamine* or Bromantan* 39 or Chloramphetamine* or Deanol* or Dexamphetamine* or Dexmethylphenidate* or 40 Dimethoxy or Methylamphetamine* or Hydroxyamphetamine* or Lefetamine* or 41 Meclofenoxate* or Mefexamide* or Methcathinone* or Methoxyamphetamine* or 42 Methylamphetamine* or Methylphenidate* or Modafinil* or Pemoline* or Picamilon* 43 or Sydnocarb* or Sydnofen* or Tetrabenazine* 44 5 AX=Butanamine* or Methylamphetamine* or Methylenedioxymethamphetamine* or 45 Ethylbarbituric* or Allylglycine* or Amfonelic* or Amiphenazole* or Apomorphine* 46 or Bemegride* or Benzphetamine* or Brucine* or Carphedon* or Cathinone* or 47 Chloramphetamine* or Convulsant* or Cropropamide* or Crotetamide* or 48 Dexamphetamine* or Dexoxadrol* or Dextroamphetamine* or Dimefline* or 49 Dimetamfetamine* or Doxapram* or Ephedrine* 50 6 AX=Etamivan* or Ethimizole* or Methylenedioxyamphetamine* or Fencamfamin* or 51 Fenetylline* or Flurothyl* or Fominoben* or Harmaline* or Homococaine* or 52 Hydroxyamphetamine* or Lobeline* or Mazindol* or Meclofenoxate* or Mefexamide* 53 or Methamphetamine* or Methcathinone* or Methylephedrine* or Methylphenidate* 54 or Ethylamphetamine* or Nikethamide* or Norcocaine* or Pemoline* or Pentetrazole* 55 or Phenmetrazine* or Phentermine* or Picrotoxin* 56 7 AX=Pipradol* or Prethcamide* or Prolintane* or Pseudoephedrine* or Pyrovalerone*

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1 or Racephedrine* or Strychnine* or Butylbicycloorthobenzoate* or 2 Butylbicyclophosphorothioate* or Tetramethylsuccinimide* or Theodrenaline* 3 8 AX=analeptic* or psychostimulant* or stimulant* 4 9 AX=cannabis or hashish or marihuana or marijua* 5 10 AX=cocaine or crack 6 11 AX=diethylpropion or ephedrine or fenfluramine or methylphenidate or pemoline or 7 phenmetrazine or phendimetrazine or phenylpropanolamine 8 12 AX=heroin or diacetylmorphine or diamorphine or morphin* or morfin* or smack or 9 methadone 10 13 AX=antaxone or dihydroxymorphinan or nalorex or naltrel or naltrexone or revia or 11 trexan or vivitrex 12 14 AX=opiate* or opioid* or opium 13 15 AX=ardinex or codein* or isocodein* or codipertussin or codyl or morfine or 14 methylmorfine or methylmorphine or pentuss or codeine 15 16 AX=dihydrocodeine or codhydrin* or codicontin or cohydrin or dehacodin or didrate 16 or dihydrin or dihydroneopine or drocode or hydrocodeine or hydrocodin or nadein* 17 or napacodin or novicodin or paracodein or paracodin or paramol or parzone or 18 rapacodin or remedacen or tiamon 19 17 AX=abstain* or abstinen* or abus* or addict* or ‘drug use’ or ‘drug user’ or ‘drug 20 user’ or dependen* or ‘injecting drug’ or ‘inject drug’ or ‘injecting drugs’ or inject 21 drugs’ or intoxicat* or misus* or overdos* or ‘illicit use’ or withdraw* 22 18 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 23 19 CS=17 AND 18 24 20 CS=19 OR 1 OR 2 25 26 27 2 Health economics and auality-of-life search filters 28 29 a. MEDLINE, EMBASE, PsycINFO, CINAHL — Ovid interface 30 31 1 exp "costs and cost analysis"/ or "health care costs"/ 32 2 exp health resource allocation/ or exp health resource utilization/ 33 3 exp economics/ or exp economic aspect/ or exp health economics/ 34 4 exp value of life/ 35 5 (burden adj5 (disease or illness)).tw. 36 6 (cost$ or economic$ or expenditure$ or price$1 or pricing or pharmacoeconomic$).tw. 37 7 (budget$ or fiscal or funding or financial or finance$).tw. 38 8 (resource adj5 (allocation$ or utilit$)).tw. 39 9 or/1-8 40 10 (value adj5 money).tw. 41 11 exp quality of life/ 42 12 (quality$ adj5 (life or survival)).tw. 43 13 (health status or QOL or well being or wellbeing).tw. 44 14 or/9-13 45 46 47 Details of additional searches undertaken to support the development of this 48 guideline are available on request. 49

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1 Appendix 11: Quality checklists for economic studies

2 1.1 Full economic evaluations 3 4 Author: Date: 5 6 Title: 7 Study design Yes No NA

1 The research question is stated ‰ ‰ 2 The viewpoint(s) of the analysis are clearly stated ‰ ‰ 3 The alternatives being compared are relevant ‰ ‰ 4 The rationale for choosing the alternative programmes or ‰ ‰ interventions compared is stated 5 The alternatives being compared are clearly described ‰ ‰ 6 The form of economic evaluation used is justified in relation to the ‰ ‰ question addressed

Data collection

1 The source of effectiveness data used is stated ‰ ‰ 2 Details of the design and results of the effectiveness study are ‰ ‰ ‰ given 3 The primary outcome measure(s) for the economic evaluation are ‰ ‰ clearly stated 4 Methods to value health states and other benefits are stated ‰ ‰ 5 Details of the subjects from whom valuations were obtained are ‰ ‰ given 6 Indirect costs (if included) are reported separately ‰ ‰ ‰ 7 Quantities of resources are reported separately from their unit ‰ ‰ costs 8 Methods for the estimation of quantities and unit costs are ‰ ‰ described 9 Currency and price data are recorded ‰ ‰ 10 Details of currency of price adjustments for inflation or currency ‰ ‰ ‰ conversion are given 11 Details of any models used are given ‰ ‰ ‰ 12 The choice of model used and the key parameters on which it is ‰ ‰ ‰ based are justified

Analysis and interpretation of results

1 Time horizon of costs and benefits is stated ‰ ‰ 2 The discount rate(s) is stated ‰ ‰ ‰ 3 The choice of rate(s) is justified ‰ ‰ ‰ 4 An explanation is given if costs or benefits are not discounted ‰ ‰ ‰ 5 Details of statistical tests and confidence intervals are given for ‰ ‰ ‰ stochastic data 6 The approach to sensitivity analysis is given ‰ ‰ 7 The choice of variables for sensitivity analysis is given ‰ ‰ 8 The ranges over which the variables are varied are stated ‰ ‰ 9 Relevant alternatives are compared ‰ ‰ 10 Incremental analysis is reported ‰ ‰ ‰

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11 Major outcomes are presented in a disaggregated as well as ‰ ‰ aggregated form 12 The answer to the study question is given ‰ ‰ 13 Conclusions follow from the data reported ‰ ‰ 14 Conclusions are accompanied by the appropriate caveats ‰ ‰

1

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1 1.2 Partial economic evaluations 2 3 Author: Date: 4 5 Title: 6 Study design Yes No NA

1 The research question is stated ‰ ‰ 2 The viewpoint(s) of the analysis is clearly stated and justified ‰ ‰

Data collection

1 Details of the subjects from whom valuations were obtained are ‰ ‰ given 2 Indirect costs (if included) are reported separately ‰ ‰ ‰ 3 Quantities of resources are reported separately from their unit ‰ ‰ costs 4 Methods for the estimation of quantities and unit costs are ‰ ‰ described 5 Currency and price data are recorded ‰ ‰ 6 Details of currency of price adjustments for inflation or currency ‰ ‰ ‰ conversion are given 7 Details of any model used are given ‰ ‰ ‰ 8 The choice of model used and the key parameters on which it is ‰ ‰ ‰ based are justified

Analysis and interpretation of results

1 Time horizon of costs is stated ‰ ‰ 2 The discount rate(s) is stated ‰ ‰ ‰ 3 Details of statistical tests and confidence intervals are given for ‰ ‰ ‰ stochastic data 4 The choice of variables for sensitivity analysis is given ‰ ‰ 5 The ranges over which the variables are varied are stated ‰ ‰ 6 Appropriate sensitivity analysis is performed ‰ ‰ 7 The answer to the study question is given ‰ ‰ 8 Conclusions follow from the data reported ‰ ‰ 9 Conclusions are accompanied by the appropriate caveats ‰ ‰ 7 8 9

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1 Appendix 12: Data extraction form for economic studies

2 Reviewer: Date of Review: 3 4 Authors: 5 Publication Date: 6 Title: 7 Country: 8 Language: 9 10 Economic study design: 11 12 ‰CEA ‰ CCA 13 ‰CBA ‰ CA 14 ‰CUA 15 ‰CMA 16 17 Modelling: 18 19 ‰ No ‰Yes 20 21 Source of data for effect size measure(s): 22 23 ‰Meta-analysis 24 ‰RCT ‰RCT 25 ‰Quasi experimental study ‰ Quasi experimental study 26 ‰Cohort study ‰ Cohort study 27 ‰Mirror image (before-after) study ‰ Mirror image (before-after) study 28 ‰ Expert opinion 29 30 Comments 31 32 Primary outcome measure(s) (please list): 33 34 35 36 Interventions compared (please describe): 37 38 Treatment: 39 40 Comparator: 41 42 43 Setting (please describe): 44 45 46 47 48 49 Patient population characteristics (please describe): 50 51 52

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1 2 3 4 Perspective of analysis: 5 6 ‰Societal ‰ Other: 7 ‰ Patient and family 8 ‰ Health care system 9 ‰ Health care provider 10 ‰ Third party payer 11 12 Time frame of analysis: 13 14 Cost data: 15 16 ‰ Primary ‰ Secondary 17 18 If secondary please specify: 19 20 Costs included: 21 22 Direct medical Direct non-medical Lost productivity 23 24 ‰ direct treatment ‰ social care ‰ income forgone due to illness 25 ‰ inpatient ‰ social benefits ‰ income forgone due to death 26 ‰ outpatient ‰ travel costs ‰ income forgone by caregiver 27 ‰ day care ‰ caregiver out-of-pocket 28 ‰ community health care ‰ criminal justice 29 ‰ medication ‰ training of staff 30 31 Or 32 33 ‰ staff 34 ‰ medication 35 ‰ consumables 36 ‰ overhead 37 ‰ capital equipment 38 ‰ real estate Others: 39 40 41 Currency: Year of costing: 42 43 44 Was discounting used? 45 ‰ Yes, for benefits and costs ‰ Yes, but only for costs ‰ No 46 47 Discount rate used for costs: 48 49 Discount rate used for benefits: 50

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1 Result(s): 2 3 4 5 6 7 8 9 10 Comments, limitations of the study: 11 12 13 14 15 16 17 18 Quality checklist score (Yes/NA/All): ……/……/…… 19 20

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1 Appendix 13: Evidence tables for economic studies

2 [To be added]

3

4 Appendices 14, 15 and 16 are available as separate files on the website.

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1 11 References

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1 Volkow, N.D., Fowler, J.S., & Wang, G.J. (1999) Imaging studies on the role of 2 dopamine in cocaine reinforcement and addiction in humans. Journal of - 3 Psychopharmacology, 13, 337-345. 4 5 Volpicelli, J. R., Markman, I., Monterosso, J., et al. (2000) Psychologically 6 enhanced treatment for cocaine-dependent mothers: evidence of efficacy. 7 Journal of Substance Abuse Treatment, 18, 41–49. 8 9 Wanigaratne, S., Davis, P., Pryce, K., et al. (2005) The Effectiveness of 10 Psychological Therapies on Drug Misusing Clients. London: NTA. 11 12 Ward, J., Henderson, Z. & Pearson, G. (2003). One Problem Among Many: Drug 13 Use Among Care Leavers in Transition to Independent Living. London: Home 14 Office. 15 16 Wechsberg, W. M., Lam, W. K., Zule, W. A., et al. (2004) Efficacy of a woman- 17 focused intervention to reduce HIV risk and increase self-sufficiency among 18 African American crack abusers. American Journal of Public Health, 94, 1165– 19 1173. 20 21 Weinstein, S. P., Gottheil, E. & Sterling, R. C. (1997) Randomized comparison 22 of intensive outpatient vs. individual therapy for cocaine abusers. Journal of 23 Addictive Diseases, 16, 41–56. 24 25 Weiss, R. D., Griffin, M. L., Najavits, L. M., et al. (1996) Self-help activities in 26 cocaine dependent patients entering treatment: results from NIDA 27 collaborative cocaine treatment study. Drug and Alcohol Dependence, 43, 79–86. 28 29 Weiss, R.D., Griffin, M.L, Gallop, R.J. (2005). The effect of 12-step self-help 30 group attendance and participation on drug use outcomes among cocaine- 31 dependent patients. Drug and Alcohol Dependence, 77, 177-184. 32 33 Weissman, M. M., & Bothwell, S. (1976). Assessment of social adjustment by 34 patient self-report. Archives of General Psychiatry, 33, 1111 – 1115. 35 36 Weissman, M. M., Prusoff, B. A., Thompson, W. D., Harding, P. S., & Myers, J. 37 K. (1978). Social adjustment by self-report in a community sample and in 38 psychiatric outpatients. Journal of Nervous Mental Disease,166, 317– 326. 39 40 Weissman, M.M., Markowitz, J.C., Klerman, G.L. (2000) Comprehensive Guide 41 to Interpersonal Therapy. New York: Basic Books. 42 43 Wexler, H. K., De Leon, G., Thomas, G., et al. (1999) The Amity prison TC 44 evaluation. Criminal Justice and Behavior, 26, 147–167. 45

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1 12 Abbreviations

2 AA Alcoholics Anonymous 3 A&E accident and emergency 4 AGREE Appraisal of Guidelines for Research and 5 Evaluation Instrument 6 AMED A bibliographic database produced by the Health 7 Care Information Service of the British Library 8 ASI Addiction Severity Index 9 ASPD antisocial personality disorder 10 AUDIT Alcohol Use Disorders Identification Test 11 12 BBV blood-borne virus 13 BCT behavioural couples therapy 14 BNF British National Formulary 15 16 CA Cocaine Anonymous 17 CBT cognitive behavioural therapy (S: standard; RP: 18 relapse prevention) 19 CENTRAL Cochrane Central Register of Controlled Trials 20 CI confidence interval 21 CINAHL Cumulative Index to Nursing and Allied Health 22 Literature 23 CM contingency management 24 CPN community psychiatric nurse 25 CRA community reinforcement approach 26 CUAD Chemical Use Abuse and Dependency scale 27 CVD cardiovascular disease 28 CXR chest x-ray 29 30 DALI Dartmouth Assessment of Lifestyle Instrument 31 DARE Database of Abstracts of Reviews of Effects 32 DARP Drug Abuse Reporting Programme 33 DAST-10 Drug Abuse Screening Test 34 DATOS Drug Abuse Treatment Outcome Study 35 DDA Drug Dependents Anonymous 36 DH Department of Health 37 DSM Diagnostic and Statistical Manual of Mental 38 Disorders (versions III-R and IV-TR) 39 DUDIT Drug Use Disorders Identification Test 40 41 EMBASE Excerpta Medica database 42 EMCDDA European Monitoring Centre for Drugs and Drug 43 Addiction 44

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1 FA Families Anonymous 2 FSO family members and significant others 3 4 GDG Guideline Development Group 5 GMC General Medical Council 6 GP general practitioner 7 GRADE Grading of Recommendations: Assessment, 8 Development and Evaluation (Working Group) 9 GRP Guideline Review Panel 10 11 HIV human immunodeficiency virus 12 HMIC Health management and policy database from the 13 Healthcare Management Information Consortium 14 HRQoL health-related quality of life 15 HTA Health Technology Assessment 16 17 ICD International Classification of Diseases (10th 18 edition) 19 ICER incremental cost-effectiveness ratio 20 IDU injecting drug user 21 IPT interpersonal therapy 22 23 24 MEDLINE Compiled by the US National Library of Medicine 25 and published on the web by Community of 26 Science, MEDLINE is a source of life sciences and 27 biomedical bibliographic information 28 MMT methadone maintenance treatment 29 MRC Medical Research Council 30 31 NA Narcotics Anonymous 32 NACRO National Association for the Care and 33 Rehabilitation of Offenders 34 NCCMH National Collaborating Centre for Mental Health 35 NDUDA National Drug Users Development Agency 36 NDTMS National Drug Treatment Monitoring System 37 NHS National Health Service 38 NHS EED National Health Service Economic Evaluation 39 Database 40 NICE National Institute for Health and Clinical 41 Excellence 42 NPV negative predictive value 43 NSC National Screening Committee 44 NSE needle and syringe exchange 45 NSF National Service Framework 46 NTA National Treatment Agency for Substance Misuse

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1 NTORS National Treatment Outcomes Research Study 2 3 OECD Organistion for Economic Co-operation and 4 Development 5 OHE HEED Office of Health Economics, Health Economics 6 Evaluation Database 7 OTI Opiate Treatment Index 8 9 PAIS International Database containing references to a wide range of 10 indexed research material from over 120 countries 11 PCT Primary Care Trust 12 PICO patient, intervention, comparison and outcome 13 PILOTS An electronic index to the worldwide literature on 14 post-traumatic stress disorder and other mental- 15 health consequences of exposure to traumatic 16 events, produced by the US National Center for 17 PTSD 18 POSIT Problem-Oriented Screening Instrument for 19 Teenagers 20 PPD purified protein derivative 21 PPV positive predictive value 22 PsycINFO An abstract (not full text) database of 23 psychological literature from the 1800s to the 24 present 25 26 QALY quality adjusted life years 27 QoL quality of life 28 29 RBT reinforcement-based therapy 30 RCT randomised controlled trial 31 RP relapse prevention 32 RR relative risk 33 RRP residential rehabilitation programme 34 35 SAS-SR Social Adjustment Scale — Self-Report 36 SD standard deviation 37 SHG self-help group 38 SIGLE System for Information on Grey Literature in 39 Europe database 40 SIGN Scottish Intercollegiate Guidelines Network 41 SMD standardised mean difference 42 SMI serious mental illness 43 SR systematic review 44 SSCI Social Sciences Citation Index 45 STPT short-term psychodynamic therapy 46

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1 TAU treatment as usual 2 TB tuberculosis 3 TC therapeutic community 4 TOPS Treatment Outcome Prospective Study 5 6 7 WHO World Health Organization 8 WMD weighted mean difference

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1

2 13 Glossary

3 12-step self-help group 4 A non-profit fellowship of people who meet regularly to help each other 5 remain abstinent. The core of the 12-step programme is a series of 12 stages 6 that include admitting to a drug problem, seeking help, self-appraisal, 7 confidential self-disclosure, making amends (when possible) where harm has 8 been done, achieving a spiritual awakening and supporting other people who 9 misuse drugs who want to recover. 10 11 Abstinence 12 Abstinence-oriented treatments aim to reduce an individual’s level of drug 13 use, with the ultimate goal of refraining from use altogether. 14 Agonist 15 An agonist is a substance that mimics the actions of a neurotransmitter or 16 hormone to produce a response when it binds to a specific receptor in the 17 brain. Opiate drugs, for example heroin and methadone, are agonists that 18 produce responses such as ‘liking’, analgesia and respiratory depression. 19 20 Alcoholics Anonymous (AA) 21 Alcoholics Anonymous is an informal fellowship of people who, through 22 shared experiences and support for one another, aim to achieve abstinence 23 and help others to recover from alcoholism. The only requirement for 24 membership is a desire to stop misusing alcohol. An international 25 organisation, AA was founded in the US in 1935 and established in the UK in 26 1947. It was from AA that the 12-step treatment model originated. 27 28 Antagonist 29 In contrast to the action of an agonist, an antagonist, such as naltrexone, 30 binds to a specific receptor in the brain but does not activate it. Therefore, if 31 an agonist, for example heroin or methadone, is present and activating the 32 receptor, taking naltrexone will counteract the activation, resulting in 33 withdrawal. 34 35 Behavioural couples therapy 36 Behavioural couples therapy usually involves (a) the person who misuses 37 drugs stating his or her intention not to use drugs each day and his or her 38 partner expressing support for the former’s efforts to stay abstinent; (b) 39 teaching more effective communication skills, such as active listening and 40 expressing feelings directly; and (c) helping to increase positive behavioural 41 exchanges between partners by encouraging them to acknowledge pleasing 42 behaviours and engage in shared recreational activities (Fals-Stewart et al., 43 2002). 44

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1 Brief intervention 2 Brief interventions are those with a maximum duration of two sessions, 3 lasting up to an hour each. The main principles include expressing empathy 4 with the service user, not opposing resistance and offering feedback in order 5 to increase the motivation of the service user to make changes to his or her 6 drug use. 7 8 Buprenorphine 9 An analgesic opiate substitute used in maintenance-oriented treatment, 10 buprenorphine has both agonist and antagonist properties. 11 12 Cannabis 13 Cannabis is a generic term denoting the various psychoactive preparations of 14 the hemp plant, including marijuana leaves, hashish resin and oil (WHO, 15 2006). It is the most commonly used illicit drug in the UK. 16 17 Case management 18 Case management is a method of co-ordinating care for people who misuse 19 drugs. An individual worker, the case manager, is responsible for the co- 20 ordination and, where necessary, provision of this care. Contact with the case 21 manager is usually expected to be on a regular ongoing basis. 22 23 Coerced/legally mandated treatment 24 Coerced, or legally mandated, treatment requires that the person who misuses 25 drugs enter into treatment as an alternative or adjunct to criminal sanctions 26 (Wild et al., 2002). Such treatment can either be legally ordered by the court or 27 through diversion away from the judicial process, usually following arrest 28 and charge for drug-related and other offences. 29 30 Cognitive behavioural therapy 31 Cognitive behavioural therapy encompasses a range of behavioural and 32 cognitive behavioural therapies, in part derived from the cognitive 33 behavioural model of affective disorders, in which the patient works 34 collaboratively with a therapist using a shared formulation to achieve specific 35 treatment goals. Such goals may include recognising the impact of 36 behavioural and/or thinking patterns on feeling states and encouraging 37 alternative cognitive and/or behavioural coping skills to reduce the severity 38 of target symptoms and problems. Therapies relevant to the field of drug 39 misuse include standard cognitive behavioural therapy and relapse- 40 prevention cognitive behavioural therapy. 41 42 Confidence interval (CI) 43 The range within which the ‘true’ values (for example, size of effect of an 44 intervention) are expected to lie with a given degree of certainty (for example, 45 95% or 99%). (Note: confidence intervals represent the probability of random 46 errors, but not systematic errors or bias.) 47

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1 Contingency management 2 Contingency management provides a system of incentives and disincentives 3 designed to make continual drug use less attractive and abstinence more 4 attractive (Griffith et al., 2000). The two main methods of providing incentives 5 are voucher-based, whereby vouchers representing monetary values are 6 provided upon receipt of biological samples (usually urine) that are negative 7 for the tested drugs, and prize-based, whereby participants receive prize- 8 draw entries upon presentation of a negative biological sample. 9 10 Dependence 11 Dependence is defined by the World Health Organization as a strong desire 12 or sense of compulsion to take a substance, a difficulty in controlling its use, 13 the presence of a physiological withdrawal state, tolerance of the use of the 14 drug, neglect of alternative pleasures and interests and persistent use of the 15 drug, despite harm to oneself and others (WHO, 2006). 16 17 Detoxification 18 Detoxification is the process by which an individual is withdrawn from the 19 effects of a psychoactive substance. As a clinical procedure, the withdrawal 20 process should be supervised and carried out in a safe and effective manner, 21 such that withdrawal symptoms are minimised. Typically, the individual is 22 clinically intoxicated or already in withdrawal at the outset of detoxification. 23 Detoxification may involve the administration of medication, the dose of 24 which is calculated to relieve withdrawal symptoms without inducing 25 intoxication, and is gradually tapered off as the individual recovers. 26 27 Drug misuse/problem drug use 28 Drug misuse is the use of a substance for a purpose not consistent with legal 29 or medical guidelines (WHO, 2006). The Advisory Council on the Misuse of 30 Drugs defines problem drug use as a condition that may cause an individual 31 to experience social, psychological, physical or legal problems related to 32 intoxication and/or regular excessive consumption, and/or dependence; any 33 injection drug use also constitutes misuse (ACMD, 1998). 34 35 36 Extended outpatient treatment 37 Treatment occurs in regularly scheduled sessions, usually totalling fewer than 38 9 contact hours per week. Examples include weekly or twice-weekly 39 individual therapy, weekly group therapy or a combination of the two in 40 association with participation in self-help groups. 41 42 Family-based intervention 43 Family-based interventions work jointly with the person who misuses drugs 44 and his or her family members, partner or others from a wider social network 45 (for example, a close friend) to seek reduced drug use or abstinence based on 46 cognitive-behavioural principles. 47

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1 Harm reduction 2 Harm reduction describes measures aiming to prevent or reduce negative 3 health or other consequences associated with drug misuse, whether to the 4 drug-using individual or to society. Attempts are not necessarily made to 5 reduce the drug use itself. 6 7 Incremental cost-effectiveness ratio (ICER) 8 The difference in the mean costs in the population of interest divided by the 9 differences in the main outcomes in the population of interest. 10 11 Interpersonal therapy 12 A discrete, time limited, structured psychological intervention that focuses on 13 interpersonal issues and where therapist and service user: a) work 14 collaboratively to identify the effects of key problematic areas related to 15 interpersonal conflicts, role transitions, grief and loss, and social skills, and 16 their effects on current drug misuse, feelings states and/or problems; and b) 17 seek to reduce drug misuse problems by learning to cope with or resolve 18 interpersonal problem areas. 19 20 Last observation carried forward (LOCF) 21 A type of data analysis used in clinical trials, often when data is lacking, in 22 which the last results before a subject drops out of the trial are counted as if 23 they occurred at the end of the trial. 24 25 Maintenance 26 Maintenance-oriented treatment in the UK context refers primarily to the 27 pharmacological maintenance of people who are opiate dependent; that is, 28 prescription of opiate substitutes (methadone or buprenorphine). This aims 29 to reduce illicit drug use and its consequent harms. 30 31 Meta-analysis 32 The use of statistical techniques in a systematic review to integrate the results 33 of several independent studies. 34 35 Methadone 36 A synthetic, psychoactive opiate substitute used in maintenance-oriented 37 treatment, particularly heroin dependence. Methadone has agonist 38 properties. 39 40 Naltrexone 41 An antagonist that blocks the effects of opiate drugs on receptors in the brain, 42 naltrexone is used in maintenance treatment. 43 44 Narcotics Anonymous (NA) 45 Narcotics Anonymous is a non-profit fellowship of men and women for 46 whom drug misuse has become a severe problem. Members meet regularly 47 with the aim of helping each other to remain abstinent. The only requirement

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1 for membership is a desire to stop misusing drugs. Originating in the US in 2 1953, the first UK NA meeting was held in 1980. At the core of the NA 3 programme is the 12-step treatment model, adapted from Alcoholics 4 Anonymous. 5 6 National Collaborating Centre for Mental Health (NCCMH) 7 One of seven centres established by the National Institute for Health and 8 Clinical Excellence (NICE) to develop guidance on the appropriate treatment 9 and care of people with specific diseases and conditions within the NHS in 10 England and Wales. Established in 2001, the NCCMH is responsible for 11 developing mental health guidelines, and is a partnership between the Royal 12 College of Psychiatrists and the British Psychological Society. 13 14 National Institute for Health and Clinical Excellence (NICE) 15 An independent organisation responsible for providing national guidance on 16 the promotion of good health and the prevention and treatment of ill health. It 17 provides guidance on three areas of health: public health, health technologies 18 and clinical practice. 19 20 National Treatment Agency for Substance Misuse (NTA) 21 The NTA is a special health authority, which was established by the 22 government in 2001. It is tasked with increasing the availability, capacity and 23 effectiveness of treatment for drug misuse in England and embraces user 24 involvement as a core component of its strategy. 25 26 Needle and syringe exchange (NSE) 27 NSE services aim to reduce transmission of blood-borne viruses through the 28 promotion of safer drug injection behaviour, primarily via the distribution of 29 sterile needles, but often also by offering education and other psychosocial 30 interventions. 31 32 Opiate 33 Opiates refer to a class of psychoactive substances derived from the poppy 34 plant, including opium, morphine and codeine, as well as their semi-synthetic 35 counterparts, including heroin (WHO, 2004). In this guideline, the term 36 ‘opiate’ is used more broadly to incorporate synthetic compounds (including 37 methadone) with similar properties, also commonly known as opioids. 38 39 Outreach 40 Outreach involves targeting high risk and local priority groups. The general 41 aims of outreach work are to: identify and contact hidden populations, refer 42 members of these populations to existing care services, initiate activities 43 aimed at prevention and at demand reduction, and to promote safer sex and 44 safer drug use (European Monitoring Centre for Drugs and Drug Addiction, 45 1999). 46 47 Point abstinence

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1 Point abstinence refers to evidence for the absence of drug use at a particular 2 point in time (for example, at the end of treatment or at 12-month follow-up). 3 4 Psychoeducation 5 Psychoeducation is a programme designed for individuals or groups of 6 people who misuse drugs that combines education about blood-borne viruses 7 with skills training to improve communication, assertiveness and safe sexual 8 and injection risk behaviour. It also provides people with an opportunity to 9 ask questions and receive relevant feedback. 10 11 Psychosocial intervention 12 Psychosocial interventions are any formal, structured psychological or social 13 intervention with assessment, clearly defined treatment plans and treatment 14 goals, and regular reviews (NTA, 2006), as opposed to advice and 15 information, drop-in support or informal keyworking. 16 17 Quality adjusted life years (QALY) 18 A form of utility measure calculated by estimating the total life years gained 19 from a treatment and weighting each year with a quality-of-life score in that 20 year. 21 22 Randomised controlled trial (RCT) 23 An experiment in which investigators randomly allocate eligible people into 24 groups to receive or not to receive one or more interventions that are being 25 compared. The results are assessed by comparing outcomes in the different 26 groups. Through randomisation, the groups should be similar in all aspects, 27 apart from the treatment they receive during the study. 28

29 Relapse-prevention cognitive behavioural therapy

30 This differs from standard cognitive behavioural therapy in the emphasis on 31 training drug users to develop skills to identify situations or states where they 32 are most vulnerable to drug use, to avoid high-risk situations, and to use a 33 range of cognitive and behavioural strategies to cope effectively with these 34 situations (Carroll & Onken, 2005). 35 36 Relative risk (RR) 37 The ratio of risk in the intervention group to the risk in the control group. The 38 risk (proportion, probability or rate) is the ratio of people with an event in a 39 group to the total in the group. An RR of 1 indicates no difference between 40 comparison groups. For undesirable outcomes, an RR that is less than 1 41 indicates that the intervention was effective in reducing the risk of that 42 outcome. 43 44 Residential rehabilitation programme

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1 Residential rehabilitation centres provide accommodation in a drug-free 2 environment and a range of structured interventions to address drug misuse, 3 including, but not limited to, abstinence-oriented interventions (NTA, 2006). 4 Services vary and are based on a number of different treatment philosophies. 5 6 Screening 7 Screening is the systematic application of a test or enquiry to identify 8 individuals at high risk of developing a specific disorder who may benefit 9 from further investigation or preventative action (Peckham & Dezateux, 10 1998). Routine screening for drug misuse in the UK is largely restricted to 11 criminal justice settings, including police custody and prisons (Matrix 12 Research and Consultancy & NACRO, 2004). 13 14 Self-help group 15 A group of people who misuse drugs meet regularly to provide help and 16 support for one another. The group is typically community-based, peer-led 17 and non-professional. 18 19 Sensitivity 20 A term used to assess screening tools, sensitivity refers to the proportion of 21 people with disease who test positive for that disease. 22 23 Short-term psychodynamic intervention 24 Psychological interventions, derived from a psychodynamic/psychoanalytic 25 model in which: a) therapist and patient explore and gain insight into conflicts 26 and how these are represented in current situations and relationships, 27 including the therapy relationship; b) service users are given an opportunity 28 to explore feelings and conscious and unconscious conflicts originating in the 29 past, with the technical focus on interpreting and working through conflicts; 30 c) therapy is non-directive and service users are not taught specific skills such 31 as thought monitoring, re-evaluation or problem solving. 32 33 Specificity 34 A term used to assess screening tools, specificity refers to the proportion of 35 people without disease who test negative for that disease. 36

37 Standard cognitive behavioural therapy

38 Standard cognitive behavioural therapy is a discrete, time limited, structured psychological 39 intervention, derived from a cognitive model of drug misuse (Beck et al., 1993). There is an 40 emphasis on identifying and modifying irrational thoughts, managing negative mood and 41 intervening after a lapse to prevent a full-blown relapse (Maude-Griffin, 1998).

42

43 Standard deviation (SD)

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1 A statistical measure of variability in a population of individuals or in a set of 2 data. Whilst the average measures the expected middle position of a group of 3 numbers, the standard deviation is a way of expressing how different the 4 numbers are from the average. The standard deviation is (approximately) the 5 amount by which the average person’s score differs from the average of all 6 scores. 7 8 Standardised mean difference (SMD) 9 In a meta-analysis, an SMD is a way of combining the results of studies that 10 may have measured the same outcome in different ways, using different 11 scales. Statistically, it is calculated by dividing the weighted average effect 12 size by the pooled standard deviation. The SMD is expressed as a standard 13 value with no units. 14 15 Stimulant 16 Stimulants refer broadly to any substances that activate, enhance or increase 17 neural activity (WHO, 2006). Illicit stimulants include cocaine, crack cocaine 18 and methamphetamine. Cocaine is one of the most commonly misused 19 stimulants in the UK; crack cocaine refers to the cocaine alkaloid that has been 20 purified from the other components of cocaine powder, and 21 methamphetamine is one of a group of synthetic substances (amphetamines) 22 with broadly similar properties to cocaine. 23 24 Systematic review (SR) 25 Research that summarises the evidence on a clearly formulated question 26 according to a predefined protocol using systematic and explicit methods to 27 identify, select and appraise relevant studies, and to extract, collate and report 28 their findings. It may or may not use statistical meta-analysis. 29 30 Therapeutic community 31 The primary goal of therapeutic communities is abstinence from illicit and 32 prescribed drugs, with the residential ‘community’ acting as the key agent for 33 change. Peer influence is used to help individuals acquire social skills and 34 learn social norms, and so take on an increased level of personal and social 35 responsibility within the unit (Smith et al., 2006). 36 37 Weighted mean difference (WMD) 38 A method of meta-analysis used to combine measures on continuous scales, 39 where the mean, standard deviation and sample size in each group are 40 known. The weight given to each study (for example, how much influence 41 each study has on the overall results of the meta-analysis) is determined by 42 the precision of its estimate of effect and, in the statistical software used by 43 the NCCMH, is equal to the inverse of the variance. This method assumes 44 that all of the trials have measured the outcome on the same scale. 45

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