Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 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
  Hide Participant Flow

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
No text entered.

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 

Period 2:   Month 3
    Bupropion   Placebo
STARTED   20   21 
COMPLETED   16   18 
Lost to Follow-up                3                3 
Withdrawal by Subject                1                0 

Period 3:   Month 6
    Bupropion   Placebo
STARTED   16   18 
COMPLETED   16   17 
Lost to Follow-up                0                1 

Period 4:   Month 9
    Bupropion   Placebo
STARTED   16   17 
COMPLETED   15   14 

  Baseline Characteristics

  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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.

  More Information