HIV Risk Reduction and Drug Abuse Treatment in Iran

Phase 2

Withdrawn

• Conditions: Opiate Dependence; HIV Infections
• Interventions: Drug: Buprenorphine/Subutex; Drug: Naltrexone; Behavioral: Drug counseling

• Registration Number: NCT00398008
• Lead Sponsor: Yale University

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 (N=130; 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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Primary Completion: 2006-12
• Study Completion: 2008-12
• Status Verified: 2013-07
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Opioid Dependence

Exclusion Criteria

• Dependence on alcohol, benzodiazepines or sedatives
• Suicide or homicide risk
• Psychotic disorder or major depression
• Inability to read or understand the protocol or assessment questions
• Life-threatening or unstable medical problems
• Greater than 3 times normal liver enzymes (AST, GGT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Buprenorphine/Subutex	DC-HIV plus buprenorphine maintenance.
1	Drug counseling	DC-HIV plus buprenorphine maintenance.
2	Drug counseling	DC-HIV plus naltrexone maintenance
2	Naltrexone	DC-HIV plus naltrexone maintenance

Primary Outcome Measures

Name	Time	Method
Time to resumption of heroin use	26 weeks
Time to relapse	26 weeks
Reduction of HIV risks	26 weeks
Maximum consecutive weeks of opiate abstinence	26 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	26 weeks
Addiction-related functional status	26 weeks

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Institute for Cognitive Studies; 🇮🇷 Tehran, Iran, Islamic Republic of