Phase 1
N=41
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
HIV Infections · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00285584 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
Jun 2012
Primary outcome: Primary: The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. — -2.5; -4 Sexual partners — p=0.9
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bupropion (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. |
-2.5; -4 | 0.9 |
| SECONDARY Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire. |
0.5; 0 | 0.3 |
| SECONDARY Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) |
3; 1 | 0.3 |
| SECONDARY Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. |
-11.5; -9 | 0.19 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00285584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.