Full Text View
Tabular View
No Study Results Posted
Related Studies
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
This study is ongoing, but not recruiting participants.
Study NCT00285584   Information provided by National Institute on Drug Abuse (NIDA)
First Received: January 31, 2006   Last Updated: March 6, 2006   History of Changes

January 31, 2006
March 6, 2006
September 2002
 
Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire)
Same as current
Complete list of historical versions of study NCT00285584 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
 
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
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.

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.

Phase I
Interventional
Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
  • HIV Infections
  • Depression
Drug: Bupropion
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
110
September 2004
 

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00285584
 
NIDA-15303-1, R01DA15303, DPMC
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Michael Marmor, PhD Department of Environmental Medicine, New York University
National Institute on Drug Abuse (NIDA)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP