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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: December 12, 2017
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):
New York University School of Medicine
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
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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
No text entered.

Reporting Groups
  Description
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
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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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      20 100.0%      21 100.0%      41 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2  10.0%      5  23.8%      7  17.1% 
Not Hispanic or Latino      18  90.0%      16  76.2%      34  82.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2  10.0%      1   4.8%      3   7.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  30.0%      4  19.0%      10  24.4% 
White      10  50.0%      16  76.2%      26  63.4% 
More than one race      2  10.0%      0   0.0%      2   4.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      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
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Time Frame From enrollment through the 9-month follow-up.
Additional Description No text entered.

Reporting Groups
  Description
Bupropion Participants in this arm received bupropion.
Placebo Participants in this arm received placebo.

Serious Adverse Events
    Bupropion   Placebo
Total, Serious Adverse Events     
# participants affected / at risk   1/20 (5.00%)   0/21 (0.00%) 
General disorders     
Hospitalization with left-sided chest pain radiating the left arm * [2]     
# participants affected / at risk   1/20 (5.00%)   0/21 (0.00%) 
# events   1   0 
Infections and infestations     
Hospitalization with acute HIV infection * [2]     
# participants affected / at risk   1/20 (5.00%)   0/21 (0.00%) 
# events   1   0 
* Events were collected by non-systematic assessment
[2] Note that both SAEs occurred in a single individual enrolled in the bupropion arm of the study.




  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.


  More Information