Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
This study has been completed.
Sponsor:
New York University
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Michael Marmor, New York University
ClinicalTrials.gov Identifier:
NCT00285584
First received: January 31, 2006
Last updated: May 17, 2012
Last verified: May 2012
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Results First Received: March 13, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Conditions: |
HIV Infections Depression |
| Interventions: |
Drug: Bupropion Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Bupropion | Participants in this arm received bupropion. |
| Placebo | Participants in this arm received placebo. |
Participant Flow for 4 periods
Period 1: Enrollment (Month 0)
| Bupropion | Placebo | |
|---|---|---|
| STARTED | 20 | 21 |
| COMPLETED | 20 | 21 |
| NOT COMPLETED | 0 | 0 |
Period 2: Month 3
| Bupropion | Placebo | |
|---|---|---|
| STARTED | 20 | 21 |
| COMPLETED | 16 | 18 |
| NOT COMPLETED | 4 | 3 |
| Lost to Follow-up | 3 | 3 |
| Withdrawal by Subject | 1 | 0 |
Period 3: Month 6
| Bupropion | Placebo | |
|---|---|---|
| STARTED | 16 | 18 |
| COMPLETED | 16 | 17 |
| NOT COMPLETED | 0 | 1 |
| Lost to Follow-up | 0 | 1 |
Period 4: Month 9
| Bupropion | Placebo | |
|---|---|---|
| STARTED | 16 | 17 |
| COMPLETED | 15 | 14 |
| NOT COMPLETED | 1 | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Bupropion | Participants in this arm received bupropion. |
| Placebo | Participants in this arm received placebo. |
| Total | Total of all reporting groups |
Baseline Measures
| Bupropion | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
20 | 21 | 41 |
|
Age
[units: years] Median ( Full Range ) |
32.5
( 23 to 48 ) |
32
( 20 to 48 ) |
32
( 20 to 48 ) |
|
Gender
[units: participants] |
|||
| Female | 0 | 0 | 0 |
| Male | 20 | 21 | 41 |
|
Ethnicity (NIH/OMB)
[units: Participants] |
|||
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 18 | 16 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Race (NIH/OMB)
[units: Participants] |
|||
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 10 | 16 | 26 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 20 | 21 | 41 |
Outcome Measures
| 1. Primary: | 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 ] |
| 2. Secondary: | 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) ] |
| 3. Secondary: | Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) [ Time Frame: Enrollment to Month 6 ] |
| 4. Secondary: | Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. [ Time Frame: Month 6 compared to enrollment (Month 0) ] |