Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
NCT ID: NCT00285584
Last Updated: 2017-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2002-09-30
2004-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Bupropion
Participants in this arm received bupropion.
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.
Placebo
Participants in this arm received placebo that looked identical to the active comparator medication.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
GlaxoSmithKline
INDUSTRY
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Michael Marmor, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Environmental Medicine, New York University
Locations
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Bellevue Hospital Center
New York, New York, United States
New York University School of Medicine
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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DPMC
Identifier Type: -
Identifier Source: secondary_id
NIDA-15303-1
Identifier Type: -
Identifier Source: org_study_id