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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Secondary Outcome 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)

Estimated Enrollment:	110
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2004

Detailed Description:

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

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285584

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Michael Marmor, PhD

Department of Environmental Medicine, New York University

More Information

No publications provided

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

Keywords provided by National Institute on Drug Abuse (NIDA):

HIV Seronegativity

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 09, 2009