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
  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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Measure Description Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
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.
Self-reported and laboratory identified sexually transmitted infections

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

Measured Values
    Bupropion     Placebo  
Number of Participants Analyzed  
[units: participants]
  20     21  
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)  
[units: participants]
  3     1  


Statistical Analysis 1 for Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.3
Risk Ratio (RR) [4] 3.15
95% Confidence Interval ( 0.4 to 27.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of cumulative incidence proportions
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Michael Marmor, Ph.D.
Organization: NYU School of Medicine
phone: 212-263-6667
e-mail: michael.marmor@nyumc.org


Publications:

Responsible Party: Michael Marmor, New York University
ClinicalTrials.gov Identifier: NCT00285584     History of Changes
Other Study ID Numbers: NIDA-15303-1, R01DA015303, DPMC
Study First Received: January 31, 2006
Results First Received: March 13, 2012
Last Updated: May 17, 2012
Health Authority: United States: Federal Government