Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael Marmor, New York University
ClinicalTrials.gov Identifier:
First received: January 31, 2006
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: March 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: HIV Infections
Interventions: Drug: Bupropion
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Bupropion Participants in this arm received bupropion.
Placebo Participants in this arm received placebo.

Participant Flow for 4 periods

Period 1:   Enrollment (Month 0)
    Bupropion     Placebo  
STARTED     20     21  
COMPLETED     20     21  
NOT COMPLETED     0     0  

Period 2:   Month 3
    Bupropion     Placebo  
STARTED     20     21  
COMPLETED     16     18  
NOT COMPLETED     4     3  
Lost to Follow-up                 3                 3  
Withdrawal by Subject                 1                 0  

Period 3:   Month 6
    Bupropion     Placebo  
STARTED     16     18  
COMPLETED     16     17  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  

Period 4:   Month 9
    Bupropion     Placebo  
STARTED     16     17  
COMPLETED     15     14  
NOT COMPLETED     1     3  

  Baseline Characteristics

  Outcome Measures
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1.  Primary:   The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.   [ Time Frame: Enrollment to Month 6 ]

2.  Secondary:   Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.   [ Time Frame: Month 6 compared to Month 0 (enrollment) ]

3.  Secondary:   Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)   [ Time Frame: Enrollment to Month 6 ]

4.  Secondary:   Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.   [ Time Frame: Month 6 compared to enrollment (Month 0) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We achieved substantially lower recruitment than needed to adequately test the study hypothesis. We also experienced substantial losses-to-follow-up.

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