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Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

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ClinicalTrials.gov Identifier: NCT00318409
Recruitment Status : Completed
First Posted : April 26, 2006
Results First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse HIV Infections Drug: Bupropion Drug: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Bupropion
buproprion XL 300mg daily
Drug: Bupropion
Other Name: Wellbutrin
Placebo Comparator: Placebo
placebo 300mg daily
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled [ Time Frame: At Enrollment ]
  2. Feasibility: Proportion of Scheduled Study Visits Completed [ Time Frame: 12 weeks ]
  3. Feasibility: Proportion of Urine Samples Collected [ Time Frame: 12 weeks ]
  4. Feasibility: Participants Who Completed the Trial [ Time Frame: 12 weeks ]
  5. Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms. [ Time Frame: throughout study ]
  6. Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings [ Time Frame: 12 weeks ]
    Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.

  7. Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report [ Time Frame: 12 weeks ]
    Proportional of reported days taking study drug during the 12 weeks of study.

  8. Acceptability: Proportion of Participants Discontinuing Medication in Both Arms [ Time Frame: 12 weeks ]
    Proportion of participants who discontinued study medication for at least one week prior to study completion.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • HIV-negative by rapid test or able to document HIV infection through healthcare provider's note or documentation of laboratory test;
  • Reports anal sex with men in prior 3 months while using meth
  • Diagnosed with meth dependence as determined by SCID
  • Interested in stopping or reducing meth use
  • Meth-positive urine on screening
  • No known allergies to bupropion
  • No current acute illnesses
  • Able and willing to provide informed consent and to be followed over a 3-month period
  • Baseline CBC and electrolytes within institutional limits.

Exclusion Criteria:

  • History of seizure
  • High risk for seizure, including: recent (last 24 months) head trauma, brain injury or surgery; using theophylline or systemic steroids; prior or current history of anorexia or bulimia; prior or current history of alcohol withdrawal symptoms
  • Measured moderate or severe liver disease (LFTs > 3 times normal) or history of chronic liver disease
  • Impaired renal function (creatinine clearance < 90 ml/min)
  • Evidence of current major depression, as determined by SCID
  • Taking anti-depressant medication within last 30 days
  • Currently on any bupropion-containing regimen
  • Currently using or unwilling not to use pseudoephedrine-containing products (causes false + urines for meth use) for trial duration
  • Currently taking antiretroviral therapy (ART)
  • CD4 count < 200 cells/mm3
  • Any condition that, in the principal investigator's judgment, interferes with safe study participation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318409

United States, California
San Francisco Department of Public Health, HIV/AIDS Office
San Francisco, California, United States, 94102
Sponsors and Collaborators
San Francisco Department of Public Health
National Institute on Drug Abuse (NIDA)
Public Health Foundation Enterprises, Inc.
Principal Investigator: Grant Colfax, M.D. Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section
More Information

Responsible Party: Phillip Coffin, MD, MIA, Medical Director, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00318409     History of Changes
Other Study ID Numbers: R21DA021090-1
R21DA021090 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2006    Key Record Dates
Results First Posted: October 17, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Autonomic Agents