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Alcohol Dependence and Harmful Alcohol Alcohol Use Disorders: Pharmacological interventions study characteristics Study characteristics for acamprosate Acamprosate vs Naltrexone Acamprosate vs Placebo ANTON2006 ANTON2006 KIEFER2003 BALTIERI2003 MORLEY2006 BARRIAS1997 RUBIO2001 BESSON1998 CHICK2000A GEERLINGS1997 GUAL2001 KIEFER2003 LADEWIG1993 MORLEY2006 NAMKOONG2003 PAILLE1995 PELC1992 PELC1997 POLDRUGO1997 ROUSSEAUX1996 SASS1996 TEMPESTA2000 WHITWORTH1996 ANTON2006 Study Type: RCT n= 1383 Data Used 1 N= 154 Study was supported by Age: Mean 44 Range 18- Relapse Naltrexone. Mean dose 100mg/day - grants from the NIAAA. Type of Analysis: ITT- as long as baseline data % days abstinent Dose of 25mg over first 4 days, dose of Acamprosate, Naltrexone Sex: 955 males 428 females and matching placebos Blindness: Double blind Leaving due to adverse events 50mg over next 4 days and then 100mg a day for the rest of the study. Placebo were donated by Lipha Duration (days): Mean 112 Leaving study early Pharmaceuticals. 100% Alcohol Dependence by DSM IV acamprosate also taken. Followup: 1 year Medication management - Delivered by Setting: recruited from 11 sites, by Exclusions: <18 years of age, no DSM diagnosis of alcohol licensed helthcare professional over 9 advertisements or clinical referrals. dependence, drinking less than 14 drinks a week if female, sessions in which pills were dispensed/ less than 21 drinks a week if male, less than 4 consecutive Initial visit was for 45 minutes, Notes: Randomisation: permuted block design, professional recommended abstinence using blocks of 9 stratified by site. Implemented days abstinent or more than 21. Further criteria: meeting DSM criteria for major psychiatric disorder or psychological and provided education about alcohol and via central telephone-based interactive voice the study medications. Encouraged AA. response system. disorder requiring medication, current dependence on my drug except nicotine, cannabis or alcohol, meeting DSM Info on Screening Process: Approximately criteria for opiod dependence in past 6 months, significant n=5000 were screened by telephone or in medical disorder, abnormal AST or ALT(3 times upper limit), person, but only n=1383 were eligible after participants who are pregnant, nursing or not using adequate asessment. birth control, individuals intending to engage other treatments for alcohol problems, individuals with previous Appendix 16e 1 Alcohol Use Disorders: Pharmacological interventions study characteristics treatment with the study interventions. 2 N= 152 Notes: Participant's were required to acknowledge a desire Acamprosate. Mean dose 3g/day - Two to stop drinking. They were also required to be drinking at 500mg tablets taken three times daily (6 least 21 drinks a week if male, 14 drinks a week if tablets in total daily). Could be lowered if male.Recommended abstinence required. Placebo naltrexone also taken. Medication management - Delivered by Baseline: Drinks/ UK % days % licensed helthcare professional over 9 % sessions in which pills were dispensed/ drinking units abstinent Married Empl- Initial visit was for 45 minutes, day oyed professional recommended abstinence PLB+MM 12.6 (7.67) 18.9 24.3 (24.74) 44.4 79.7 and provided education about alcohol and NALX+MM 12.7 (7.69) 19.1 29.8 (24.70) 38.3 72.7 the study medications. Encouraged AA. ACAM+MM 12.2 (7.77) 18.3 24.6 (24.78) 36.2 71.7 NALX+ 3 N= 148 ACAM+MM 12.4 (7.66) 18.6 22.9 (24.70) 42.6 70.9 Naltrexone + Acamprosate - Combines PLB+CBI 12.6 (7.74) 18.9 24.3 (24.73) 50.0 71.8 the dosing schedule for naltrexone and NALX+CBI 12.4 (7.72) 18.6 23.7 (24.78) 37.4 76.8 acamprosate alone interventions ACAM+CBI 13.2 (7.74) 19.8 25.3 (24.70) 44.4 70.9 Medication management - Delivered by NALX+ licensed helthcare professional over 9 ACAM+CBI 12.2 (7.77) 18.3 26.8 (24.68) 43.3 sessions in which pills were dispensed/ 70.7 Initial visit was for 45 minutes, CBI only 11.8 (7.66) 17.7 23.5 (25.35) 41.4 69.4 professional recommended abstinence and provided education about alcohol and the study medications. Encouraged AA. 4 N= 153 Placebo - Inactive placebo tablets identical in appearance to active acamprosate and naltrexone taken on the same dosing schedule as the active interventions. Medication management - Delivered by licensed helthcare professional over 9 sessions in which pills were dispensed/ Initial visit was for 45 minutes, professional recommended abstinence and provided education about alcohol and the study medications. Encouraged AA. 5 N= 155 Naltrexone - Dose of 25mg over first 4 days, dose of 50mg over next 4 days and then 100mg a day for the rest of the study. Placebo acamprosate also taken. Combined behavioural intervention + MM - Up to 20 sessions of 50 minutes delivered by health specialists. Integrated aspects of coping skills (project MATCH), 12-step facilitation, motivational interviewing and support system involvement. Medication management also provided. Appendix 16e 2 Alcohol Use Disorders: Pharmacological interventions study characteristics 6 N= 151 Acamprosate - Two 500mg tablets taken three times daily (6 tablets in total daily). Could be lowered if required. Placebo naltrexone also taken. Combined behavioural intervention + MM - Up to 20 sessions of 50 minutes delivered by health specialists. Integrated aspects of coping skills (project MATCH), 12-step facilitation, motivational interviewing and support system involvement. Medication management also provided. 7 N= 157 Naltrexone + Acamprosate - Combines the dosing schedule for naltrexone and acamprosate alone interventions Combined behavioural intervention + MM - Up to 20 sessions of 50 minutes delivered by health specialists. Integrated aspects of coping skills (project MATCH), 12-step facilitation, motivational interviewing and support system involvement. Medication management also provided. 8 N= 156 Placebo - Inactive placebo tablets identical in appearance to active acamprosate and naltrexone taken on the same dosing schedule as the active interventions. Combined behavioural intervention + MM - Up to 20 sessions of 50 minutes delivered by health specialists. Integrated aspects of coping skills (project MATCH), 12-step facilitation, motivational interviewing and support system involvement. Medication management also provided. 9 N= 157 Combined behavioural intervention - Up to 20 sessions of 50 minutes delivered by health specialists. Integrated aspects of coping skills (project MATCH), 12-step facilitation, motivational interviewing and support system involvement. BALTIERI2003 Study Type: RCT n= 75 Data Used 1 N= 40 Funding: no details Age: Mean 44 Range 18-59 Abstinent at endpoint Acamprosate. Mean dose 1998mg/day - Type of Analysis: ITT - all taking one dose of Leaving study early No details on dosing schedule. study medication Sex: all males 100% Alcohol Dependence by ICD-10 Appendix 16e 3 Alcohol Use Disorders: Pharmacological interventions study characteristics Blindness: Double blind Psychosocial program - GREA - Duration (days): Mean 84 Exclusions: <18 or >59 years of age, Female, no diagnosis behavioural orientation, clinical of alcohol dependence (ICD-10 criteria), weighing less than assessment and encouragement to join Followup: 12 weeks 60kg. Further criteria: clinical and psychiatric pathologies AA (not mandatory) who needed treatment and previous psychotic pictures, as 2 N= 35 Setting: Participants were enrolled as well as use of psychiatric and non-psychiatric medications. outpatients in a treatment clinic for drug Placebo - Inactive control intervention, no dependence at the university of Sao Paulo. details on dosing schedule Baseline: Acamp PLB Notes: No details Average daily 370.1 (164.9) 348.5 (132.46) Psychosocial program - GREA - behavioural orientation, clinical Info on Screening Process: n=80 participants alcohol intake (g/day) assessment and encouragement to join were screened, but n=5 were excluded In UK units: 46.26 43.56 AA (not mandatory) because of coextisting diseases. BARRIAS1997 Study Type: RCT n= 302 Data Used 1 N= 150 Age: Mean 40 Range 21-64 % continuously abstinent Acamprosate - Awaiting translation Blindness: Double blind Sex: 278 males 24 females 2 N= 152 Duration (days): Mean 365 Placebo - Awaiting translation Followup: six months Setting: Awaiting translation Exclusions: Awaiting translation BESSON1998 Study Type: RCT n= 110 Data Used 1 N= 31 Funding: supported in part Age: Mean 42 Range 18-65 Relapse Acamprosate. Mean dose 1998mg/day - by state funds and Lipha, Type of Analysis: ITT - all taking one dose of Abstinent at endpoint 1998mg/day divided into 6 tablets for Inc. study medication Sex: 88 males 22 females Abstinent at assessment participants weighing 60kg or more, or Blindness: Double blind CAD 1332mg/day for participants under 60kg. Duration (days): Mean 360 100% Alcohol Dependence by DSM-III Leaving study early Supportive psychotherapy - Non- standardised supportive treatment, Data Not Used generally consisted of short sessions (15- Setting: 3 psychiatric centres that treat Exclusions: <18 or >65 years of age, no DSM-III diagnosis of GGT - Not relevant participants on a voluntary basis for short to 20 minutes) of psychological assessment alcohol dependence with at least a 12-month history, GGT Notes: Relapse: any alcohol consumption. medium periods. <twice upper limit, MCV <95fl, <5 days abstinent before and support approximately twice a month. 2 N= 33 Notes: Randomisation: stratified for voluntary study start. Further criteria: pregnancy or women not ONLY CAD is recorded for acamprosate vs intake of disulfiram practicing
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