title: Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men.
abstract: 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.
authors.affiliation: HIV Prevention Section, San Francisco Department of Public Health, CA 94102, USA. moupali.das-douglas@ucsf.edu
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Deirdre
authors.initials: D
authors.lastname: Santos
authors.forename: Tim
authors.initials: T
authors.lastname: Matheson
authors.forename: Glenn-Milo
authors.initials: GM
authors.lastname: Santos
authors.forename: Priscilla
authors.initials: P
authors.lastname: Chu
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.forename: Steve
authors.initials: S
authors.lastname: Shoptaw
authors.forename: Grant N
authors.initials: GN
authors.lastname: Colfax
mesh_terms: D000293:Adolescent; D000328:Adult; D019969:Amphetamine-Related Disorders / Q000188:drug therapy* / Q000523:psychology; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D016642:Bupropion / Q000627:therapeutic use*; D005240:Feasibility Studies; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D008694:Methamphetamine; D008875:Middle Aged; D018579:Patient Selection; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion; D008694:Methamphetamine
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