Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183768
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2005-09-14
Brief Title:
Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Antidepressant Treatment to Reduce HIV Risk Among IDUs
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This study will evaluate the effectiveness of combining cognitive behavioral therapy CBT and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed intravenous drug users
Detailed Description:
Depression is common among injection drug users IDUs it is estimated that up to 50 of IDUs meet the diagnostic criteria for major depressive disorder a severe form of depression The combination of drug abuse and depression increases the likelihood of engaging in HIV high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs Research has shown that IDUs who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who have not received treatment for depression Combination treatment which includes cognitive behavioral therapy CBT and antidepressant medication has been shown to be the most effective treatment for depression This study will evaluate the effectiveness of combination treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted IDUs with a diagnosis of depression
In this 9-month study participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment Participants assigned to combination treatment will receive the antidepressant Celexa and will attend 8 CBT sessions and 7 psychopharmacology sessions Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes If a participant does not respond well to Celexa Wellbutrin or Effexor may be taken instead Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels drug use and high-risk sexual behaviors Blood will be drawn at baseline and Month 9 for HIV testing
In this 9-month study participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment Participants assigned to combination treatment will receive the antidepressant Celexa and will attend 8 CBT sessions and 7 psychopharmacology sessions Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes If a participant does not respond well to Celexa Wellbutrin or Effexor may be taken instead Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels drug use and high-risk sexual behaviors Blood will be drawn at baseline and Month 9 for HIV testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR AZ-M | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH061141 |
| R01MH061141 | NIH | None | None |