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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285584
First Posted: February 2, 2006
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
GlaxoSmithKline
Information provided by (Responsible Party):
Michael Marmor, New York University
Results First Submitted: March 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: HIV Infections
Depression
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.
No text entered.

Reporting Groups
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 20   21   41 
Age 
[Units: Years]
Median (Full Range)
 32.5 
 (23 to 48) 
 32 
 (20 to 48) 
 32 
 (20 to 48) 
Gender 
[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
  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
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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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