Clinical trial NCT00285584: Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Official title: Drug Abuse, Depression and Responses to HIV Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Depression
Keywords: HIV infection
Depression
Men who have sex with men
Drug abuse
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: GlaxoSmithKline
First posted: 2006-02-02
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
timeFrame: Enrollment to Month 6
Secondary outcomes:
measure: Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
timeFrame: Month 6 compared to Month 0 (enrollment)
measure: Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
timeFrame: Enrollment to Month 6
measure: Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
timeFrame: Month 6 compared to enrollment (Month 0)
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: Department of Environmental Medicine, New York University
name: Michael Marmor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, Nadas 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. doi: 10.1097/01.aids.0000244207.49123.ff.
citation: Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. doi: 10.1007/s11524-005-9003-8.
citation: 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. doi: 10.1521/aeap.16.5.448.48739.
citation: 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. doi: 10.1016/j.amjcard.2004.01.072.