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

January 31, 2006
May 17, 2012
September 2002
March 2004   (final data collection date for primary outcome measure)
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.
Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire)
Complete list of historical versions of study NCT00285584 on ClinicalTrials.gov Archive Site
  • 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
  • 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)
Not Provided
Not Provided
 
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Drug Abuse, Depression and Responses to HIV Counseling

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Depression
  • 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
  • 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.
  • Active Comparator: Bupropion
    Participants in this arm received bupropion.
    Intervention: Drug: Bupropion
  • Placebo Comparator: Placebo
    Participants in this arm received placebo that looked identical to the active comparator medication.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
September 2004
March 2004   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00285584
NIDA-15303-1, R01DA015303, DPMC
Yes
Michael Marmor, New York University
New York University
  • National Institute on Drug Abuse (NIDA)
  • GlaxoSmithKline
Principal Investigator: Michael Marmor, PhD Department of Environmental Medicine, New York University
New York University
May 2012

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