HIV Risk Reduction and Drug Abuse Treatment in Iran
Primary Purpose
Opiate Dependence, HIV Infections
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Buprenorphine/Subutex
Naltrexone
Drug counseling
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring Buprenorphine, Naltrexone, HIV risk reduction behavior, Counseling, HIV Seronegativity
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)
Sites / Locations
- Yale University School of Medicine
- Institute for Cognitive Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
DC-HIV plus buprenorphine maintenance.
DC-HIV plus naltrexone maintenance
Outcomes
Primary Outcome Measures
Time to resumption of heroin use
Time to relapse
Maximum consecutive weeks of opiate abstinence
Reduction of HIV risks
Secondary Outcome Measures
Addiction-related functional status
Adverse events
Full Information
NCT ID
NCT00398008
First Posted
November 9, 2006
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00398008
Brief Title
HIV Risk Reduction and Drug Abuse Treatment in Iran
Official Title
HIV Risk Reduction and Drug Abuse Treatment in Iran
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never able to start in IRAN
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, HIV Infections
Keywords
Buprenorphine, Naltrexone, HIV risk reduction behavior, Counseling, HIV Seronegativity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
DC-HIV plus buprenorphine maintenance.
Arm Title
2
Arm Type
Experimental
Arm Description
DC-HIV plus naltrexone maintenance
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/Subutex
Other Intervention Name(s)
Subutex
Intervention Description
Opioid agonist medication to treat opiate dependence
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Opioid antagonist medication to treat opiate dependence
Intervention Type
Behavioral
Intervention Name(s)
Drug counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to resumption of heroin use
Time Frame
26 weeks
Title
Time to relapse
Time Frame
26 weeks
Title
Maximum consecutive weeks of opiate abstinence
Time Frame
26 weeks
Title
Reduction of HIV risks
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Addiction-related functional status
Time Frame
26 weeks
Title
Adverse events
Time Frame
26 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S. Schottenfeld, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azarakhsh Mokri, M.D.
Organizational Affiliation
Rouzbeh Hospital, Tehran, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Institute for Cognitive Studies
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
HIV Risk Reduction and Drug Abuse Treatment in Iran
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