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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Withdrawn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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
November 9, 2006
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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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Withdrawn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

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HIV Risk Reduction and Drug Abuse Treatment in Iran

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