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

Tracking Information
First Submitted Date ICMJE	January 31, 2006
First Posted Date ICMJE	February 2, 2006
Results First Submitted Date	March 13, 2012
Results First Posted Date	June 20, 2012
Last Update Posted Date	December 12, 2017
Study Start Date ICMJE	September 2002
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 17, 2012)	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.
Original Primary Outcome Measures ICMJE; (submitted: January 31, 2006)	Change in partners in unprotected intercourse between study entry and Month 6 (measured by an HIV Risk Questionnaire)
Change History	Complete list of historical versions of study NCT00285584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 17, 2012)	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.; 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.; 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
Original Secondary Outcome Measures ICMJE; (submitted: January 31, 2006)	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)
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Official Title ICMJE	Drug Abuse, Depression and Responses to HIV Counseling
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	HIV Infections; Depression
Intervention ICMJE	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.
Study Arms	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
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 17, 2012)	41
Original Enrollment ICMJE; (submitted: January 31, 2006)	110
Actual Study Completion Date	September 2004
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00285584
Other Study ID Numbers ICMJE	NIDA-15303-1; R01DA015303 ( U.S. NIH Grant/Contract ); DPMC
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	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
IPD Sharing Statement	Not Provided
Responsible Party	New York University School of Medicine
Study Sponsor ICMJE	New York University School of Medicine
Collaborators ICMJE	National Institute on Drug Abuse (NIDA); GlaxoSmithKline
Investigators ICMJE	Principal Investigator: Michael Marmor, PhD Department of Environmental Medicine, New York University
PRS Account	New York University School of Medicine
Verification Date	November 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP