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Sponsors and Collaborators: |
Yale University National Institute on Drug Abuse (NIDA) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00398008 |
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 |
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Opiate Dependence HIV Infections |
Drug: Buprenorphine/Subutex Drug: Naltrexone Behavioral: Drug counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | HIV Risk Reduction and Drug Abuse Treatment in Iran |
Enrollment: | 129 |
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 |
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1: Experimental
DC-HIV plus buprenorphine maintenance.
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Drug: Buprenorphine/Subutex
Opioid agonist 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
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2: Experimental
DC-HIV plus naltrexone maintenance
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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
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Richard S. Schottenfeld, M.D. | Yale University |
Study Director: | Azarakhsh Mokri, M.D. | Rouzbeh Hospital, Tehran, Iran |
Responsible Party: | Yale University School of Medicine ( Richard S. Schottenfeld, MD ) |
Study ID Numbers: | R01-DA14718-02S1 |
Study First Received: | November 9, 2006 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00398008 |
Health Authority: | United States: Institutional Review Board |
Buprenorphine Naltrexone HIV risk reduction behavior Counseling HIV Seronegativity |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Opioid-Related Disorders Immunologic Deficiency Syndromes Virus Diseases Buprenorphine |
HIV Infections Mental Disorders Sexually Transmitted Diseases Naltrexone Substance-Related Disorders Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Infection |
Pharmacologic Actions Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |