CompletedNCT00318409Updated Oct 17, 2014Results posted

Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

A Phase 2 interventional study of Bupropion and Placebo in Substance Abuse and HIV Infections, sponsored by San Francisco Department of Public Health. Completed at 1 site in United States. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-17.

Sponsored by San Francisco Department of Public Health · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: Male

Study 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.

Read the detailed description

The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population. The MSM meth epidemic, and its link with HIV transmission, underscores the need to pilot test new, innovative modalities to reduce meth use and meth-associated sexual risk behavior. Ultimately, a pharmacologic treatment for meth use may not only serve to improve outcomes among those who are accessing current treatment services, but might also benefit those who are not willing or able to utilize such services. While studies show that MSM who enter substance use treatment decrease both their substance use and sexual risk behavior, current behavioral meth treatment programs report low rates of success in treating meth dependence among MSM. We believe the time has come to test the acceptability of pharmacologic interventions to reduce meth use among MSM, and to assess the feasibility of conducting such trials among sexually active, meth-dependent MSM, whose meth-associated sexual behavior use places them at extraordinarily high risk for transmitting or acquiring HIV. In this pilot study, we will provide meth-dependent MSM with placebo or daily bupropion XL (extended-release), a well-tolerated dopamine agonist that has potential to reduce meth use. The specific aims of this study are:

To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized, double-blind study of bupropion versus placebo with biologic (urine meth testing) and behavioral (sexual risk) measures.
To explore the tolerability of bupropion and placebo among meth-dependent MSM, as determined by the number of adverse clinical events in the bupropion and placebo arms.
To describe the acceptability of bupropion and placebo among meth-dependent MSM, by measuring (via electronic pill caps) medication adherence to bupropion and placebo.

This randomized, double-blind, placebo-controlled, two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo. We will include both HIV- and HIV-INFECTED MSM, because meth use is common in both groups. We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment. Participants will be seen weekly for urine specimen collection and substance-use counseling. Clinical exams, medical history, specimen collection, and behavioral assessments will be performed at baseline and at the 1, 2, and 3 month visits. Interim visits will be scheduled whenever indicated by signs or symptoms. Our decision to maintain participants on 3 months of bupropion is based on the smoking literature, which demonstrated bupropion's efficacy in treating nicotine addiction within similar time periods; we anticipate that any future efficacy trial will maintain participants on bupropion for this duration.

Conditions studied

Substance Abuse
HIV Infections

Browse trials for

Substance-Related Disorders 2,124

Keywords

Methamphetamine
HIV

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 30 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

San Francisco Department of Public Health is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Active comparator
Bupropion
buproprion XL 300mg daily
Drug: Bupropion
Placebo comparator
Placebo
placebo 300mg daily
Drug: Placebo

Interventions

DrugBupropion
Also known as: Wellbutrin
DrugPlacebo

What researchers measure

Primary outcomes

Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled
Time frame: At Enrollment
Feasibility: Proportion of Scheduled Study Visits Completed
Time frame: 12 weeks
Feasibility: Proportion of Urine Samples Collected
Time frame: 12 weeks
Feasibility: Participants Who Completed the Trial
Time frame: 12 weeks
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks

Results

Posted Oct 17, 2014

Participant flow

Participants were actively recruited at the municipal STD and HIV clinics, and by street outreach. Recruitment flyers were posted at locations of active recruitment, in local newspapers and in print media and on social networking websites.

Participant flow — Overall Study
Milestone	Bupropion	Placebo
Started	20	10
Completed	18	9
Not completed	2	1

Outcome measures

PrimaryFeasibility: Proportion of Persons Screened Who Are Eligible and Enrolled

Time frame:: At Enrollment
Reported as:: Number · Eligible persons screened who enrolled

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

PrimaryFeasibility: Proportion of Scheduled Study Visits Completed

Time frame:: 12 weeks
Reported as:: Number · Scheduled study visits completed

Feasibility: Proportion of Scheduled Study Visits Completed
Scheduled study visits completed	Bupropion	Placebo
Feasibility: Proportion of Scheduled Study Visits Completed	185	96

PrimaryFeasibility: Proportion of Urine Samples Collected

Time frame:: 12 weeks
Reported as:: Number · Urine samples collected

Feasibility: Proportion of Urine Samples Collected
Urine samples collected	Bupropion	Placebo
Feasibility: Proportion of Urine Samples Collected	193	97

PrimaryFeasibility: Participants Who Completed the Trial

Time frame:: 12 weeks
Reported as:: Number · participants who completed the trial

Feasibility: Participants Who Completed the Trial
participants who completed the trial	Bupropion	Placebo
Feasibility: Participants Who Completed the Trial	18	9

PrimaryTolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.

Time frame:: throughout study
Reported as:: Number · number of adverse events

Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
number of adverse events	Bupropion	Placebo
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.	40	11

PrimaryAcceptability: 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.

Time frame:: 12 weeks
Reported as:: Number · percentage adherence by MEMS

Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings
percentage adherence by MEMS	Bupropion	Placebo
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings	59	62

Statistical analysis

Bupropion vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.98

PrimaryAcceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report

Proportional of reported days taking study drug during the 12 weeks of study.

Time frame:: 12 weeks
Reported as:: Number · percentage of self-reported adherence

Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report
percentage of self-reported adherence	Bupropion	Placebo
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report	85	75

PrimaryAcceptability: Proportion of Participants Discontinuing Medication in Both Arms

Proportion of participants who discontinued study medication for at least one week prior to study completion.

Time frame:: 12 weeks
Reported as:: Number · percentage of discontinuations

Acceptability: Proportion of Participants Discontinuing Medication in Both Arms
percentage of discontinuations	Bupropion	Placebo
Acceptability: Proportion of Participants Discontinuing Medication in Both Arms	15	30

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bupropion	—	0/20 (0%)	17/20 (85%)
Placebo	—	0/10 (0%)	6/10 (60%)

Most frequent other events

Showing 10 of 22

Most frequent other events
Event	Bupropion	Placebo
Soft tissue infectionInfections and infestations	4/20	0/10
Increased ALTHepatobiliary disorders	4/20	2/10
Increased ASTHepatobiliary disorders	3/20	2/10
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders	2/20	2/10
GastroenteritisGastrointestinal disorders	3/20	0/10
Increased creatinineRenal and urinary disorders	3/20	0/10
Stimulant toxicityInjury, poisoning and procedural complications	0/20	1/10
DyspepsiaGastrointestinal disorders	0/20	1/10
Sexually transmitted infectionInfections and infestations	1/20	1/10
HyperbilirubinemiaHepatobiliary disorders	2/20	0/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Bupropion	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	20	10	30
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Bupropion	Placebo	Total
Female	0	0	0
Male	20	10	30

Study locations

1 site

San Francisco Department of Public Health, HIV/AIDS Office
San Francisco, California 94102, United States

References and documents

Publications

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. PubMed 20397286 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00318409
Lead sponsor: San Francisco Department of Public Health
Collaborators: National Institute on Drug Abuse (NIDA), Public Health Foundation Enterprises, Inc.
Responsible party: Phillip Coffin, MD, MIA (Medical Director, San Francisco Department of Public Health) — Principal investigator
First posted: Apr 26, 2006
Start date: Sep 2006
Primary completion: Nov 2007
Completion: Nov 2007
Results posted: Oct 17, 2014
Last update: Oct 17, 2014

Study contacts

Grant Colfax, M.D.

principal investigator · Co-Director, HIV /AIDS Statistics, Epidemiology and Intervention Research Section

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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