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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
HIV Infections
Drug: Buprenorphine/Subutex
Drug: Naltrexone
Behavioral: Drug counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIV Risk Reduction and Drug Abuse Treatment in Iran

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Addiction-related functional status [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2004
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DC-HIV plus buprenorphine maintenance.
Drug: Buprenorphine/Subutex
Opioid agonist medication to treat opiate dependence
Other Name: Subutex
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: 2
DC-HIV plus naltrexone maintenance
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398008

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Iran, Islamic Republic of
Institute for Cognitive Studies
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Study Director: Azarakhsh Mokri, M.D. Rouzbeh Hospital, Tehran, Iran
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00398008     History of Changes
Other Study ID Numbers: R01-DA14718-02S1
Study First Received: November 9, 2006
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Buprenorphine
Naltrexone
HIV risk reduction behavior
Counseling
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 14, 2014