Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

Completed · Phase 2 · Has a placebo group

Conditions studied: Substance Abuse, HIV Infections

In brief

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.

Key facts

Study ID

NCT00318409

Run by

San Francisco Department of Public Health

People needed

30

Starts

2006-09-01

Expected to finish

2007-11-01

Last updated by the study team

2014-10-17

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco Department of Public Health, HIV/AIDS Office — San Francisco, California, United States

Full record on ClinicalTrials.gov

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