Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Drug Abuse, Depression and Responses to HIV Counseling
3 other identifiers
interventional
41
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Sep 2002
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 2, 2006
CompletedResults Posted
Study results publicly available
June 20, 2012
CompletedDecember 12, 2017
November 1, 2017
1.5 years
January 31, 2006
March 13, 2012
November 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
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.
Enrollment to Month 6
Secondary Outcomes (3)
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
Month 6 compared to Month 0 (enrollment)
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Enrollment to Month 6
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
Month 6 compared to enrollment (Month 0)
Study Arms (2)
Bupropion
ACTIVE COMPARATORParticipants in this arm received bupropion.
Placebo
PLACEBO COMPARATORParticipants in this arm received placebo that looked identical to the active comparator medication.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
- GlaxoSmithKlinecollaborator
Study Sites (2)
Bellevue Hospital Center
New York, New York, 10016-3240, United States
New York University School of Medicine
New York, New York, 10016-3240, United States
Related Publications (4)
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.
PMID: 16954729BACKGROUNDMarmor 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.
PMID: 16736351BACKGROUNDHalkitis 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.
PMID: 15491956BACKGROUNDMarmor 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.
PMID: 15135709BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We achieved substantially lower recruitment than needed to adequately test the study hypothesis. We also experienced substantial losses-to-follow-up.
Results Point of Contact
- Title
- Michael Marmor, Ph.D.
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Marmor, PhD
Department of Environmental Medicine, New York University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 2, 2006
Study Start
September 1, 2002
Primary Completion
March 1, 2004
Study Completion
September 1, 2004
Last Updated
December 12, 2017
Results First Posted
June 20, 2012
Record last verified: 2017-11