Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

This study has been completed.
Sponsor:
Collaborators:
Public Health Foundation Enterprises, Inc.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT00318409
First received: April 24, 2006
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Substance Abuse
HIV Infections
Drug: Bupropion
Drug: Placebo
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by San Francisco Department of Public Health:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion
buproprion XL 300mg daily
Drug: Bupropion
Other Name: Wellbutrin
Placebo Comparator: Placebo
placebo 300mg daily
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318409

Locations
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
Public Health Foundation Enterprises, Inc.
Investigators
Principal Investigator: Grant Colfax, M.D. Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section
  More Information

Publications:
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
Study First Received: April 24, 2006
Results First Received: April 24, 2013
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by San Francisco Department of Public Health:
Methamphetamine
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Bupropion
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sympathomimetics

ClinicalTrials.gov processed this record on October 21, 2014