HIV Risk Reduction and Drug Abuse Treatment in Iran

HIV Infections Clinical Trial

Official title:

HIV Risk Reduction and Drug Abuse Treatment in Iran

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00398008
• Other study ID #: 0207018835
• Secondary ID: R01DA014718-02S1
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: December 2008

Study information

• Verified date: July 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections
• Opiate Dependence
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/Subutex
Opioid agonist medication to treat opiate dependence
• Naltrexone
Opioid antagonist medication to treat opiate dependence

Behavioral:
• Drug counseling
DC-HIV: Drug Counseling that provides education about HIV, drug abuse and dependence; encourages medication adherence; uses motivational enhancement techniques; encourages life style changes; and teaches cognitive and behavioral coping skills to prevent relapse

Locations

Country	Name	City	State
Iran, Islamic Republic of	Institute for Cognitive Studies	Tehran
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resumption of heroin use		26 weeks
Primary	Time to relapse		26 weeks
Primary	Maximum consecutive weeks of opiate abstinence		26 weeks
Primary	Reduction of HIV risks		26 weeks
Secondary	Addiction-related functional status		26 weeks
Secondary	Adverse events		26 weeks