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

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Bupropion Participants in this arm received bupropion.
Placebo Participants in this arm received placebo.
Total Total of all reporting groups

Baseline Measures
    Bupropion     Placebo     Total  
Number of Participants  
[units: participants]
  20     21     41  
[units: years]
Median (Full Range)
  32.5   (23 to 48)     32   (20 to 48)     32   (20 to 48)  
[units: participants]
Female     0     0     0  
Male     20     21     41  
Ethnicity (NIH/OMB)  
[units: Participants]
Hispanic or Latino     2     5     7  
Not Hispanic or Latino     18     16     34  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
American Indian or Alaska Native     0     0     0  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     4     10  
White     10     16     26  
More than one race     2     0     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
United States     20     21     41  

  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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