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HIV Risk Reduction and Drug Abuse Treatment in Iran

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ClinicalTrials.gov Identifier: NCT00398008
Recruitment Status : Withdrawn (Study was never able to start in IRAN)
First Posted : November 10, 2006
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIV Risk Reduction and Drug Abuse Treatment in Iran
Study Start Date : October 2004
Actual Primary Completion Date : December 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Medicines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to resumption of heroin use [ Time Frame: 26 weeks ]
  2. Time to relapse [ Time Frame: 26 weeks ]
  3. Maximum consecutive weeks of opiate abstinence [ Time Frame: 26 weeks ]
  4. Reduction of HIV risks [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Addiction-related functional status [ Time Frame: 26 weeks ]
  2. Adverse events [ Time Frame: 26 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398008


Locations
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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
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Study Director: Azarakhsh Mokri, M.D. Rouzbeh Hospital, Tehran, Iran
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00398008    
Other Study ID Numbers: 0207018835
R01DA014718-02S1 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: July 2013
Keywords provided by Yale University:
Buprenorphine
Naltrexone
HIV risk reduction behavior
Counseling
HIV Seronegativity
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Naltrexone
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents