HIV Risk Reduction and Drug Abuse Treatment in Iran

• Sponsor: Yale University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00398008
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 0
• Locations: 2
• Arms: 2
• Duration (Months): 50
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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

• Study Type: Interventional
• 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: Oct 1, 2004
• Actual Primary Completion Date: Dec 1, 2006
• Anticipated Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 DC-HIV plus buprenorphine maintenance.	Drug: Buprenorphine/Subutex; Opioid agonist medication to treat opiate dependence; Other Names: 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

Primary Outcome Measures

1. Time to resumption of heroin use [26 weeks]

2. Time to relapse [26 weeks]

3. Maximum consecutive weeks of opiate abstinence [26 weeks]

4. Reduction of HIV risks [26 weeks]

Secondary Outcome Measures

1. Addiction-related functional status [26 weeks]

2. Adverse events [26 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06519
2	Institute for Cognitive Studies	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Richard S. Schottenfeld, M.D., Yale University
• Study Director: Azarakhsh Mokri, M.D., Rouzbeh Hospital, Tehran, Iran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00398008
• Other Study ID Numbers: 0207018835; R01DA014718-02S1
• First Posted: Nov 10, 2006
• Last Update Posted: Mar 30, 2020
• Last Verified: Jul 1, 2013

• Keywords provided by Yale University: Buprenorphine; Naltrexone; HIV risk reduction behavior; Counseling; HIV Seronegativity
• Additional relevant MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Naltrexone; Buprenorphine

Study Results

No Results Posted as of Mar 30, 2020