HIV Infections Clinical Trial
Official title:
Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | San Francisco Department of Public Health, HIV/AIDS Office | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
San Francisco Department of Public Health | National Institute on Drug Abuse (NIDA), Public Health Foundation Enterprises, Inc. |
United States,
Das M, Santos D, Matheson T, Santos GM, Chu P, Vittinghoff E, Shoptaw S, Colfax GN. Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men. AIDS. 2010 Apr 24; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled | At Enrollment | No | |
Primary | Feasibility: Proportion of Scheduled Study Visits Completed | 12 weeks | No | |
Primary | Feasibility: Proportion of Urine Samples Collected | 12 weeks | No | |
Primary | Feasibility: Participants Who Completed the Trial | 12 weeks | No | |
Primary | Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms. | throughout study | Yes | |
Primary | Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings | Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug. | 12 weeks | No |
Primary | Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report | Proportional of reported days taking study drug during the 12 weeks of study. | 12 weeks | No |
Primary | Acceptability: Proportion of Participants Discontinuing Medication in Both Arms | Proportion of participants who discontinued study medication for at least one week prior to study completion. | 12 weeks | No |
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