Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: San Francisco Department of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Public Health Foundation Enterprises, Inc.
• Treatments: Bupropion; Methamphetamine

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.