Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2006
CompletedFirst Posted
Study publicly available on registry
April 26, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
October 17, 2014
CompletedOctober 17, 2014
October 1, 2014
1.2 years
April 24, 2006
April 24, 2013
October 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled
At Enrollment
Feasibility: Proportion of Scheduled Study Visits Completed
12 weeks
Feasibility: Proportion of Urine Samples Collected
12 weeks
Feasibility: Participants Who Completed the Trial
12 weeks
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
throughout study
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
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
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
Study Arms (2)
Bupropion
ACTIVE COMPARATORbuproprion XL 300mg daily
Placebo
PLACEBO COMPARATORplacebo 300mg daily
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Department of Public Health, HIV/AIDS Office
San Francisco, California, 94102, United States
Related Publications (1)
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;24(7):991-1000. doi: 10.1097/qad.0b013e328336e98b.
PMID: 20397286RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Moupali Das, MD, MPH
- Organization
- San Francisco Department of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Grant Colfax, M.D.
Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
April 24, 2006
First Posted
April 26, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
October 17, 2014
Results First Posted
October 17, 2014
Record last verified: 2014-10