HIV Risk Reduction and Drug Abuse Treatment in Iran

This study has been withdrawn prior to enrollment.
(Study was never able to start in IRAN)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00398008
First received: November 9, 2006
Last updated: July 25, 2013
Last verified: July 2013

November 9, 2006
July 25, 2013
October 2004
December 2006   (final data collection date for primary outcome measure)
  • Time to resumption of heroin use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Time to relapse [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Maximum consecutive weeks of opiate abstinence [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Reduction of HIV risks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Time to resumption of heroin use
  • Time to relapse
  • Maximum consecutive weeks of opiate abstinence
  • Reduction of HIV risks
Complete list of historical versions of study NCT00398008 on ClinicalTrials.gov Archive Site
  • Addiction-related functional status [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Addiction-related functional status
  • Adverse events
Not Provided
Not Provided
 
HIV Risk Reduction and Drug Abuse Treatment in Iran
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Opiate Dependence
  • HIV Infections
  • Drug: Buprenorphine/Subutex
    Opioid agonist medication to treat opiate dependence
    Other Name: Subutex
  • 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
  • Experimental: 1
    DC-HIV plus buprenorphine maintenance.
    Interventions:
    • Drug: Buprenorphine/Subutex
    • Behavioral: Drug counseling
  • Experimental: 2
    DC-HIV plus naltrexone maintenance
    Interventions:
    • Drug: Naltrexone
    • Behavioral: Drug counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2008
December 2006   (final data collection date for primary outcome measure)

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)
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Iran, Islamic Republic of
 
NCT00398008
R01-DA14718-02S1
Not Provided
Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Study Director: Azarakhsh Mokri, M.D. Rouzbeh Hospital, Tehran, Iran
Yale University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP