Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University; NYU Langone Health
• Collaborators: GlaxoSmithKline; National Institute on Drug Abuse (NIDA)
• Treatments: Bupropion

Criteria

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 criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and 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