Phase 2 N=30 Randomized Quadruple-blind Treatment

Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

Substance Abuse · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00318409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled — 30 Eligible persons screened who enrolled

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bupropion (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: San Francisco Department of Public Health
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled	30	—
PRIMARY Feasibility: Proportion of Scheduled Study Visits Completed	185; 96	—
PRIMARY Feasibility: Proportion of Urine Samples Collected	193; 97	—
PRIMARY Feasibility: Participants Who Completed the Trial	18; 9	—
PRIMARY Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.	40; 11	—
PRIMARY Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings	59; 62	0.98
PRIMARY Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report	85; 75	—
PRIMARY Acceptability: Proportion of Participants Discontinuing Medication in Both Arms	15; 30	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00318409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.