Official Title: “HIV Risk Reduction and Drug Abuse Treatment in Iran”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2006

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • DC-HIV plus buprenorphine maintenance.
• Experimental: 2
  • DC-HIV plus naltrexone maintenance

Primary Measures

• Time to resumption of heroin use
  • Time Frame: 26 weeks
    Safety Issue?: No
• Time to relapse
  • Time Frame: 26 weeks
    Safety Issue?: No
• Maximum consecutive weeks of opiate abstinence
  • Time Frame: 26 weeks
    Safety Issue?: No
• Reduction of HIV risks
  • Time Frame: 26 weeks
    Safety Issue?: No

Secondary Measures

• Addiction-related functional status
  • Time Frame: 26 weeks
    Safety Issue?: No
• Adverse events
  • Time Frame: 26 weeks
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Richard S. Schottenfeld, M.D. Principal Investigator Yale University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00398008

Study ID Number: R01-DA14718-02S1

ClinicalTrials.gov Identifier: NCT00398008

Health Authority: United States: Institutional Review Board