Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285584
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2006-01-31
Brief Title:
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men MSM
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Drug Abuse Depression and Responses to HIV Counseling
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA015303 | NIH | None | None |
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA015303 |