Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.|
- Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled [ Time Frame: At Enrollment ] [ Designated as safety issue: No ]
- Feasibility: Proportion of Scheduled Study Visits Completed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Feasibility: Proportion of Urine Samples Collected [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Feasibility: Participants Who Completed the Trial [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.
- Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Proportional of reported days taking study drug during the 12 weeks of study.
- Acceptability: Proportion of Participants Discontinuing Medication in Both Arms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Proportion of participants who discontinued study medication for at least one week prior to study completion.
|Study Start Date:||September 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Bupropion
buproprion XL 300mg daily
Other Name: Wellbutrin
Placebo Comparator: Placebo
placebo 300mg daily
The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population. The MSM meth epidemic, and its link with HIV transmission, underscores the need to pilot test new, innovative modalities to reduce meth use and meth-associated sexual risk behavior. Ultimately, a pharmacologic treatment for meth use may not only serve to improve outcomes among those who are accessing current treatment services, but might also benefit those who are not willing or able to utilize such services. While studies show that MSM who enter substance use treatment decrease both their substance use and sexual risk behavior, current behavioral meth treatment programs report low rates of success in treating meth dependence among MSM. We believe the time has come to test the acceptability of pharmacologic interventions to reduce meth use among MSM, and to assess the feasibility of conducting such trials among sexually active, meth-dependent MSM, whose meth-associated sexual behavior use places them at extraordinarily high risk for transmitting or acquiring HIV. In this pilot study, we will provide meth-dependent MSM with placebo or daily bupropion XL (extended-release), a well-tolerated dopamine agonist that has potential to reduce meth use. The specific aims of this study are:
- To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized, double-blind study of bupropion versus placebo with biologic (urine meth testing) and behavioral (sexual risk) measures.
- To explore the tolerability of bupropion and placebo among meth-dependent MSM, as determined by the number of adverse clinical events in the bupropion and placebo arms.
- To describe the acceptability of bupropion and placebo among meth-dependent MSM, by measuring (via electronic pill caps) medication adherence to bupropion and placebo.
This randomized, double-blind, placebo-controlled, two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo. We will include both HIV- and HIV-INFECTED MSM, because meth use is common in both groups. We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment. Participants will be seen weekly for urine specimen collection and substance-use counseling. Clinical exams, medical history, specimen collection, and behavioral assessments will be performed at baseline and at the 1, 2, and 3 month visits. Interim visits will be scheduled whenever indicated by signs or symptoms. Our decision to maintain participants on 3 months of bupropion is based on the smoking literature, which demonstrated bupropion's efficacy in treating nicotine addiction within similar time periods; we anticipate that any future efficacy trial will maintain participants on bupropion for this duration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318409
|United States, California|
|San Francisco Department of Public Health, HIV/AIDS Office|
|San Francisco, California, United States, 94102|
|Principal Investigator:||Grant Colfax, M.D.||Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section|