Back to resultsBupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Primary Purpose
HIV Infections, Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV infection, Depression, Men who have sex with men, Drug abuse
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
Sites / Locations
- Bellevue Hospital Center
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bupropion
Placebo
Arm Description
Participants in this arm received bupropion.
Participants in this arm received placebo that looked identical to the active comparator medication.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
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)
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.
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
Full Information
NCT ID
NCT00285584
First Posted
January 31, 2006
Last Updated
November 14, 2017
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00285584
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), GlaxoSmithKline
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Depression
Keywords
HIV infection, Depression, Men who have sex with men, Drug abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupropion
Arm Type
Active Comparator
Arm Description
Participants in this arm received bupropion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm received placebo that looked identical to the active comparator medication.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Brand name of bupropion used in the trial: Wellbutrin SR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Description
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.
Time Frame
Enrollment to Month 6
Secondary Outcome Measure Information:
Title
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
Description
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.
Time Frame
Month 6 compared to Month 0 (enrollment)
Title
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Description
Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
Time Frame
Enrollment to Month 6
Title
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
Description
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
Time Frame
Month 6 compared to enrollment (Month 0)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Marmor, PhD
Organizational Affiliation
Department of Environmental Medicine, New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016-3240
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016-3240
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16954729
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.
Results Reference
background
PubMed Identifier
16736351
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.
Results Reference
background
PubMed Identifier
15491956
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.
Results Reference
background
PubMed Identifier
15135709
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.
Results Reference
background
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Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
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