December 6, 2000 NIDA-CTN-0007 MOTIVATIONAL INCENTIVES FOR ENHANCED DRUG ABUSE RECOVERY: METHADONE CLINICS Maxine Stitzer, Ph.D., Lead Investigator Nancy Petry, Ph.D. Co-Lead Investigator Robert Brooner, Ph.D. Co-Investigator Jessica Peirce, Project Coordinator Protocol work group: Nancy Petry New England Paul McLaughlin New England Richard Rawson Pacific Frank Flammino Pacific Bob Forman Delaware Valley Peter Barbur Northwest Sara Lamb Northwest Scott Kellogg New York Elaine Pencer New York Jack Blaine NIDA NIDA-CTN-0007 Motivational Incentives: Methadone Clinic 1 Version 6, Date December 6, 2000 December 6, 2000 TABLE OF CONTENTS 1 LIST OF ABBREVIATIONS................................................................................................. 3 2 PROTOCOL SUMMARY...................................................................................................... 4 3 BACKGROUND AND SIGNIFICANCE.............................................................................. 7 4 STUDY OBJECTIVE........................................................................................................... 10 5 SUSTAINABILITY WITHIN THE CTP’S ........................................................................ 10 6 STUDY DESIGN.................................................................................................................. 11 6.1 Drug targets....................................................................................................................... 11 6.2 Bonus incentive targets: opiates........................................................................................ 11 7 CTP ELIGIBILITY CRITERIA: .......................................................................................... 11 8 STUDY PARTICIPANTS.................................................................................................... 12 8.1 Inclusion criteria:.............................................................................................................. 12 8.2 Exclusion criteria:............................................................................................................. 12 9 PROJECTED STUDY SAMPLE SIZE: 400........................................................................ 12 10 STUDY INTAKE RATE; SAMPLE SIZE PER CLINIC; ENROLLMENT PERIOD ....... 13 11 STUDY PROCEDURES...................................................................................................... 13 11.1 Timeline ........................................................................................................................ 14 11.2 Study intake procedures for methadone clinics ............................................................ 17 11.3 Study drop-out criteria .................................................................................................. 18 11.4 Sample collection and testing procedures..................................................................... 18 11.5 Variable ratio incentive procedures .............................................................................. 19 12 ROLE OF COUNSELORS IN THE PROTOCOL.............................................................. 22 13 FOLLOW-UP PROCEDURES............................................................................................ 23 14 STUDY ASSESSMENT BATTERY ................................................................................... 23 15 OTHER PRE-STUDY AND DURING STUDY DATA TO BE COLLECTED................. 25 15.1 Pre-study client retention and drug use......................................................................... 25 15.2 Counseling utilization................................................................................................... 25 16 ANALYSIS PLAN............................................................................................................... 21 16.1 Primary during study outcomes .................................................................................... 21 16.2 Secondary during study outcomes ................................................................................ 21 16.3 Follow-up outcomes...................................................................................................... 22 16.4 Data analysis plans........................................................................................................ 22 16.5 Other statistical issues................................................................................................... 23 17 STUDY HYPOTHESES....................................................................................................... 28 17.1 Primary Hypotheses: During treatment data................................................................. 24 17.2 Primary hypothesis: Follow-up data ............................................................................. 28 17.3 Secondary hypotheses: During treatment data.............................................................. 24 17.4 Secondary hypotheses: Follow-up data ........................................................................ 24 18 HUMAN SUBJECTS........................................................................................................... 24 18.1 Risks.............................................................................................................................. 25 18.2 Benefits ......................................................................................................................... 26 18.3 Informed consent.......................................................................................................... 26 18.4 Confidentiality .............................................................................................................. 30 18.5 Risk/benefit ratio........................................................................................................... 31 19 SIGNATURES...................................................................................................................... 27 NIDA-CTN-0007 Motivational Incentives: Methadone Clinic 2 Version 6, Date December 6, 2000 December 6, 2000 20 REFERENCES ..................................................................................................................... 28 NIDA-CTN-0007 Motivational Incentives: Methadone Clinic 3 Version 6, Date December 6, 2000 December 6, 2000 1 LIST OF ABBREVIATIONS Abbreviation Definition BSI Brief Symptom Inventory CRF Case Report Form CTN clinical trial node CTP community treatment program HIV human immunodeficiency virus IRB Institutional Review Board NIDA National Institute on Drug Abuse RA research assistant SUR substance use report THC tetrahydrocannabinol NIDA-CTN-0007 Motivational Incentives: Methadone Clinic 4 Version 6, Date December 6, 2000 December 6, 2000 2 PROTOCOL SUMMARY STUDY OBJECTIVES: The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics. The study will determine if motivational incentives along with standard care therapy is more effective than standard therapy alone for the treatment of patients using cocaine or methamphetamine and entering a substance abuse treatment program. STUDY POPULATION/ELIGIBILITY CRITERIA: The study population will be drawn from patients entering methadone maintenance treatment and remaining in treatment for at least one month. Primary eligibility criteria for study entry is evidence of stimulant use (cocaine or methamphetamine) as determined by urinalysis test results. Eligible patients must submit at least one cocaine or methamphetamine positive urine within the two weeks prior to study entry. STUDY DESIGN: The study utilizes a two group random assignment design. Thus, interested and eligible participant volunteers will be assigned to receive usual care or usual care supplemented by a motivational incentive program. The study lasts for 12 weeks, with follow-up interviews scheduled at 1, 3 and 6 months after study enrollment. USUAL CARE TREATMENT: Those assigned to usual care will receive standard counseling procedures used at the CTP for 12 weeks. Participants assigned to the usual care condition will be expected to meet with the RA twice weekly to give urine samples and to participate in follow- up interviews, as scheduled. INCENTIVE PROCEDURES: In addition to usual care services, those subjects in the motivational incentive group will be given the opportunity to receive tangible incentives twice weekly based on drug-free urine test results. Each time a participant tests negative for the primary target drugs cocaine, methamphetamine, amphetamines, and alcohol (via breathalyzer), they will be able to make recovery picks from the abstinence bowl. Some picks will result in no incentive award. Some picks will result in receipt of a “small” incentive such as a soda, candy bar or toiletry item. Yet other picks may result in receipt of a larger incentive such as a radio, walkman or gift certificate to a local restaurant, grocery or retail store. Clients and clinic staff will determine the specific incentives to be awarded within monetary guidelines specified in the protocol. The number of recovery picks escalates with consecutive weeks in which urine tests are negative for all 4 primary target substances. Bonus picks are also available at each incentive opportunity for urines that test negative for opiates. The maximum cash value of tangible