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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Michael Marmor, New York University
ClinicalTrials.gov Identifier:
NCT00285584
First received: January 31, 2006
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Depression
Drug: Bupropion
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Drug Abuse, Depression and Responses to HIV Counseling

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. [ Time Frame: Enrollment to Month 6 ] [ Designated as safety issue: No ]
    The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.


Secondary Outcome Measures:
  • Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire. [ Time Frame: Month 6 compared to Month 0 (enrollment) ] [ Designated as safety issue: No ]
    Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.

  • Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) [ Time Frame: Enrollment to Month 6 ] [ Designated as safety issue: No ]
    Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.

  • Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. [ Time Frame: Month 6 compared to enrollment (Month 0) ] [ Designated as safety issue: No ]
    The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment


Enrollment: 41
Study Start Date: September 2002
Study Completion Date: September 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion
Participants in this arm received bupropion.
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.
Other Name: Brand name of bupropion used in the trial: Wellbutrin SR
Placebo Comparator: Placebo
Participants in this arm received placebo that looked identical to the active comparator medication.
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.

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 are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors.

Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
New York University
GlaxoSmithKline
Investigators
Principal Investigator: Michael Marmor, PhD Department of Environmental Medicine, New York University
  More Information

Publications:
Responsible Party: Michael Marmor, Professor of Environmental Medicine and Medicine, New York University
ClinicalTrials.gov Identifier: NCT00285584     History of Changes
Other Study ID Numbers: NIDA-15303-1, R01DA015303, DPMC
Study First Received: January 31, 2006
Results First Received: March 13, 2012
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University:
HIV infection
Depression
Men who have sex with men
Drug abuse

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014