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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:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Michael Marmor, New York University
ClinicalTrials.gov Identifier:
NCT00285584
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
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  
Number of Participants  
[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
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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 ]
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Measure Type Primary
Measure Title The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Measure Description The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.
Time Frame Enrollment to Month 6  
Safety Issue No  

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.
Subjects remaining in study through 6-Month study visit.

Reporting Groups
  Description
Bupropion 6 months
Placebo 6 months

Measured Values
    Bupropion     Placebo  
Number of Participants Analyzed  
[units: participants]
  16     17  
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.  
[units: Sexual partners]
Median ( Full Range )
  -2.5  
  ( -50 to 0 )  
  -4  
  ( -10 to 4 )  


Statistical Analysis 1 for The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.9
Median Difference (Final Values) [4] 1.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
  No text entered.



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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