Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
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ClinicalTrials.gov Identifier: NCT00285584 |
Recruitment Status
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Completed
First Posted
: February 2, 2006
Results First Posted
: June 20, 2012
Last Update Posted
: December 12, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 31, 2006 | ||||||
First Posted Date ICMJE | February 2, 2006 | ||||||
Results First Submitted Date | March 13, 2012 | ||||||
Results First Posted Date | June 20, 2012 | ||||||
Last Update Posted Date | December 12, 2017 | ||||||
Study Start Date ICMJE | September 2002 | ||||||
Actual Primary Completion Date | March 2004 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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 ] 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.
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Original Primary Outcome Measures ICMJE |
Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire) | ||||||
Change History | Complete list of historical versions of study NCT00285584 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM) | ||||||
Official Title ICMJE | Drug Abuse, Depression and Responses to HIV Counseling | ||||||
Brief Summary | The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression. | ||||||
Detailed Description | Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors. Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
41 | ||||||
Original Enrollment ICMJE |
110 | ||||||
Actual Study Completion Date | September 2004 | ||||||
Actual Primary Completion Date | March 2004 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT00285584 | ||||||
Other Study ID Numbers ICMJE | NIDA-15303-1 R01DA015303 ( U.S. NIH Grant/Contract ) DPMC |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | New York University School of Medicine | ||||||
Study Sponsor ICMJE | New York University School of Medicine | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | New York University School of Medicine | ||||||
Verification Date | November 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |