Official Title: “Drug Abuse, Depression and Responses to HIV Counseling”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Bupropion

Primary Measures

• Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire)

Secondary Measures

• Change in self-reported frequency of substance abuse between study entry and Month 6 (measured by a Questionnaire)
• incidence of sexually transmitted infections between study entry and Month 6 (measured by a questionnaire and serologic tests)

Inclusion Criteria:

• Available for at least 9 months, or the duration of the study
• Willing to complete HIV testing and counseling
• History of HIV testing and counseling
• At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry
• Meets DSM-IV criteria for either major depression, mild-to-moderate dysthymia, or minor depression with one of the following symptoms: significant change in weight, poor sleep pattern, irritability, fatigue, feelings of worthlessness or guilt, inability to concentrate, or recurrent thoughts of death or suicide

Exclusion Criteria:

• HIV infected
• Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship
• Currently enrolled in another study involving repeated HIV testing and counseling
• Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry
• Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason
• Severe depression or at suicidal risk
• No evidence or prior history of depression
• Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants
• Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI.
• History of seizures
• History or current symptoms of bipolar disorder

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Michael Marmor, PhD Principal Investigator Department of Environmental Medicine, New York University  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00285584

Study ID Number: NIDA-15303-1

ClinicalTrials.gov Identifier: NCT00285584

Health Authority: United States: Federal Government