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

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

March 31, 2004

Study Completion Date

September 30, 2004

Conditions
HIV InfectionsDepression
Interventions
DRUG

Bupropion

Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.

DRUG

Placebo

Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.

Trial Locations (2)

10016-3240

Bellevue Hospital Center, New York

New York University School of Medicine, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

GlaxoSmithKline

INDUSTRY

lead

NYU Langone Health

OTHER