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

• ClinicalTrials.gov Identifier: NCT00285584
• Recruitment Status: Completed
• First Posted: February 2, 2006
• Results First Posted: June 20, 2012
• Last Update Posted: December 12, 2017
• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA); GlaxoSmithKline
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections; Depression	Drug: Bupropion; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Drug Abuse, Depression and Responses to HIV Counseling
• Study Start Date: September 2002
• Actual Primary Completion Date: March 2004
• Actual Study Completion Date: September 2004

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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) ]
   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.
2. Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) [ Time Frame: Enrollment to Month 6 ]
   Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
3. Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. [ Time Frame: Month 6 compared to enrollment (Month 0) ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

NYU Langone Health

National Institute on Drug Abuse (NIDA)

GlaxoSmithKline

Investigators

• Principal Investigator: Michael Marmor, PhD; Department of Environmental Medicine, New York University

More Information

Publications:

Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, Nádas A, Borkowsky W, Marmor M. CCR5 expression and duration of high risk sexual activity among HIV-seronegative men who have sex with men. AIDS. 2006 Sep 11;20(14):1879-83.

Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. Review.

Halkitis PN, Zade DD, Shrem M, Marmor M. Beliefs about HIV non-infection and risky sexual behavior among MSM. AIDS Educ Prev. 2004 Oct;16(5):448-58.

Marmor M, Penn A, Widmer K, Levin RI, Maslansky R. Coronary artery disease and opioid use. Am J Cardiol. 2004 May 15;93(10):1295-7.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00285584
• Other Study ID Numbers: NIDA-15303-1; R01DA015303 ( U.S. NIH Grant/Contract ); DPMC
• First Posted: February 2, 2006
• Results First Posted: June 20, 2012
• Last Update Posted: December 12, 2017
• Last Verified: November 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by NYU Langone Health:

HIV infection; Depression; Men who have sex with men; Drug abuse

Additional relevant MeSH terms:

HIV Infections; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors