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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00398008
Other study ID # 0207018835
Secondary ID R01DA014718-02S1
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 2004
Est. completion date December 2008

Study information

Verified date July 2013
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2008
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Intervention

Drug:
Buprenorphine/Subutex
Opioid agonist medication to treat opiate dependence
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

Locations

Country Name City State
Iran, Islamic Republic of Institute for Cognitive Studies Tehran
United States Yale University School of Medicine New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to resumption of heroin use 26 weeks
Primary Time to relapse 26 weeks
Primary Maximum consecutive weeks of opiate abstinence 26 weeks
Primary Reduction of HIV risks 26 weeks
Secondary Addiction-related functional status 26 weeks
Secondary Adverse events 26 weeks
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