Clinical trial NCT00398008: HIV Risk Reduction and Drug Abuse Treatment in Iran
Official title: HIV Risk Reduction and Drug Abuse Treatment in Iran
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opiate Dependence
HIV Infections
Keywords: Buprenorphine
Naltrexone
HIV risk reduction behavior
Counseling
HIV Seronegativity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-11-10
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Time to resumption of heroin use
timeFrame: 26 weeks
measure: Time to relapse
timeFrame: 26 weeks
measure: Maximum consecutive weeks of opiate abstinence
timeFrame: 26 weeks
measure: Reduction of HIV risks
timeFrame: 26 weeks
Secondary outcomes:
measure: Addiction-related functional status
timeFrame: 26 weeks
measure: Adverse events
timeFrame: 26 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tehran
country: Iran, Islamic Republic of
facility: Institute for Cognitive Studies
Study officials:
affiliation: Yale University
name: Richard S. Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rouzbeh Hospital, Tehran, Iran
name: Azarakhsh Mokri, M.D.
role: STUDY_DIRECTOR
References: