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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00285584 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Depression |
Drug: Bupropion |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Drug Abuse, Depression and Responses to HIV Counseling |
| Estimated Enrollment: | 110 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | September 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Bellevue Hospital Center | |
| New York, New York, United States, 10016-3240 | |
| New York University School of Medicine | |
| New York, New York, United States, 10016-3240 | |
| Principal Investigator: | Michael Marmor, PhD | Department of Environmental Medicine, New York University |
More Information
| Study ID Numbers: | NIDA-15303-1, R01DA15303, DPMC |
| Study First Received: | January 31, 2006 |
| Last Updated: | March 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00285584 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV Seronegativity |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Infection Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation Retroviridae Infections Antidepressive Agents RNA Virus Infections |
Depression Immune System Diseases Acquired Immunodeficiency Syndrome Depressive Disorder Immunologic Deficiency Syndromes Pharmacologic Actions Behavioral Symptoms Virus Diseases HIV Infections Sexually Transmitted Diseases Bupropion Lentivirus Infections Mood Disorders Dopamine Agents Central Nervous System Agents |