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| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2006 | ||||
| Last Updated Date | March 6, 2006 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| 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 | Same as current | ||||
| 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 | Depressed individuals often participate in high-risk behavior due to solemn feelings. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in helping depressed HIV negative men who have sex with men (MSM) to adopt healthy and protective behavior changes. |
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| 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 is among the highest risk groups for HIV/AIDS due to high-risk behaviors, such as unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study is to evaluate how bupropion affects the likelihood of high-risk behaviors in MSM diagnosed with depression. Participants in this trial will be randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting 2 hours will occur at Day 0, and at Months 4, 6, and 9. These study visits will include a physical exam, HIV and sexually transmitted disease (STD) testing, and depression screening. In addition, participants will complete self-reports regarding sexual activity and drug use. Shorter study visits will occur at Day 15, and Months 1, 2, 4, 5, and 7; these visits will take between 15 and 30 minutes to complete. They will include depression screening and a physical exam. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Bupropion | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 110 | ||||
| Completion Date | September 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00285584 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-15303-1, R01DA15303, DPMC | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | January 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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