Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398008
Status:
WITHDRAWN
Last Update Posted:
2020-03-30
First Post:
2006-11-09
Brief Title:
HIV Risk Reduction and Drug Abuse Treatment in Iran
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
HIV Risk Reduction and Drug Abuse Treatment in Iran
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never able to start in IRAN
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling DC-HIV for heroin and opium addicts in Iran
Detailed Description:
This randomized double blind clinical trial compares the efficacy of buprenorphine maintenance treatment BMT and naltrexone maintenance treatment NMT for recently detoxified opioid dependent patients N130 65 heroin dependent 65 opium dependent-Specific Aim 1 Manual-guided HIV risk reduction and drug counseling DC-HIV is provided to all patients as the platform psychotherapy Maintenance treatment is provided for 12 weeks to all patients patients may also continue to receive maintenance treatment for an additional 12 weeks following the initial treatment period Primary outcome measures assessed by twice weekly urine toxicology testing and self-report during the first 12 weeks and monthly during the 12-week extension include resumption of heroin use 1 and 3 weeks continuous relapse and reductions in HIV risk behaviors The project will also evaluate the characteristics of treatment-seeking opioid addicts in Iran including specific risk behaviors and patterns of HIV risk behaviors prevalence of psychiatric and other medical comorbidity and patterns of social family vocational and criminal activity and service needs-Specific Aim 2 This data will be used to revise the DC-HIV manual to address the specific circumstances and risk behaviors of opioid addicts in Iran and to provide data regarding any differential response of opium compared to heroin addicts to BMT or NMT Finally the project will also provide clinical training for health professionals and training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers who will continue development implementation evaluation and dissemination of HIV prevention and drug abuse treatment approaches in Iran after the project ends Specific Aim 3 The Institute for Cognitive Science Studies will collaboratively fund the project and lead subsequent dissemination and drug abuse and HIV risk reduction efforts in Iran
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 |
|---|---|---|---|
| R01DA014718-02S1 | NIH | None | httpsreporternihgovquickSearchR01DA014718-02S1 |