HIV Risk Reduction and Drug Abuse Treatment in Iran

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HIV Risk Reduction and Drug Abuse Treatment in Iran

Conditions
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Opiate Dependence, HIV Infections

Intervention / Treatment
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* Drug: Buprenorphine/Subutex
* Drug: Naltrexone
* Behavioral: Drug counseling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DC-HIV plus buprenorphine maintenance. | Drug: Buprenorphine/Subutex<br>* Opioid agonist medication to treat opiate dependence<br>* Other names: Subutex;Behavioral: Drug counseling<br>* 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<br>|
| Experimental: 2<br>DC-HIV plus naltrexone maintenance | Drug: Naltrexone<br>* Opioid antagonist medication to treat opiate dependence<br>Behavioral: Drug counseling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resumption of heroin use |  | 26 weeks | 
| Time to relapse |  | 26 weeks | 
| Maximum consecutive weeks of opiate abstinence |  | 26 weeks | 
| Reduction of HIV risks |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction-related functional status |  | 26 weeks | 
| Adverse events |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buprenorphine, Naltrexone, HIV risk reduction behavior, Counseling, HIV Seronegativity