Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
Condition: Substance Abuse; HIV Infections
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual
      behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or
      acquiring HIV. No studies have tested the feasibility and acceptability of conducting
      pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among
      MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining
      meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the
      tolerability of and adherence to medication among these participants.
    

Detailed description: 
      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:

        1. 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.

        2. 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.

        3. 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.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Wellbutrin
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methamphetamine; HIV