Objective: To determine whether actively using, methamphetamine (meth)-dependent men who have sex with men (MSM) could be enrolled and retained in a pharmacologic intervention trial, and the degree to which participants would adhere to study procedures, including medication adherence.
Study design: Phase II randomized, double-blind trial of bupropion vs. placebo.
Methods: Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion XL 300 mg or placebo for 12 weeks. Participants received weekly substance use counseling, provided weekly urine specimens, and completed monthly audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps (the number of distinct MEMS cap openings divided by the number of expected doses) and self-report.
Results: Ninety percent completed the trial: 89% of monthly ACASIs were completed, 81% of study visits were attended, and 81% of urine samples were collected. Adherence by MEMS cap was 60% and by self-report was 81% and did not differ significantly by treatment assignment. The median number of positive urine samples was 5.5 out of a possible 11 (50%). Participants in both arms reported similar declines in the median number of sex partners (P = 0.52). No serious adverse events occurred and there were no significant differences in adverse events by treatment assignment (P = 0.11).
Conclusions: It is feasible to enroll and retain actively using, meth-dependent MSM in a pharmacologic intervention. Bupropion was well tolerated. Study participation and retention rates were high, however, study drug medication adherence was only moderate. Findings support a larger trial with improved adherence support to evaluate the efficacy of bupropion and other pharmacologic interventions for meth dependence in this population.
aSan Francisco Department of Public Health, USA
bUniversity of California, San Francisco, USA
cUniversity of California, Los Angeles, California, USA.
Received 6 November, 2009
Revised 11 December, 2009
Accepted 15 December, 2009
Correspondence to Moupali Das, MD, MPH, Director of Research, HIV Prevention Section, San Francisco Department of Public Health, Assistant Clinical Professor, Divisions of HIV/AIDS and Infectious Diseases, University of California, San Francisco, 25 Van Ness, Suite 500, San Francisco, CA 94102, USA. Tel: +1 415 823 0050; fax: +1 415 437 4693; e-mail: email@example.com