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Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China

Primary Purpose

Opiate Dependence, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
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 drug counseling, HIV risks, methadone maintenance, HIV Seronegativity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • opioid dependence

Exclusion Criteria:

  • current dependence on alcohol, benzodiazepines or sedatives
  • current suicide or homicide risk
  • current psychotic disorder or untreated major depression
  • life-threatening or unstable medical problems

Sites / Locations

  • Yale University School of Medicine - CMHC
  • Wuhan Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Methadone maintenance treatment with Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

Methadone maintenance treatment with standard drug counseling

Outcomes

Primary Outcome Measures

Reductions of illicit opiate use
Reductions in HIV risk behaviors

Secondary Outcome Measures

Full Information

First Posted
September 22, 2008
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
NCT00757744
Brief Title
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
Official Title
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with methadone maintenance treatment in Wuhan, China
Detailed Description
This project is a supplement to a parent grant, Drug Counseling and Abstinence-Contingent Take-Home Buprenorphine in Malaysia. The specific aims of the parent grant include evaluating whether the relatively minimal counseling and other services provided with standard buprenorphine maintenance treatment (Standard BUP) is sufficient or whether one or a combination of two enhanced behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve its efficacy (Specific Aim 1) and are cost-effective, with regard to the direct economic costs of providing the treatments (Specific Aim 2) and also to provide training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers and clinical training for health professionals in Malaysia (Specific Aim 4). BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in developing countries. The specific aims of the proposed study are consistent with the specific aims of the parent grant and include evaluating in a pilot, randomized clinical trial in a methadone treatment program in Wuhan, China, the feasibility and potential efficacy for reducing illicit drug use and HIV risk behaviors of BDRC when combined with standard methadone treatment services (Standard Methadone) compared to Standard Methadone only (Specific Aim 1 of the proposed study). Additional Specific Aims of the proposed study include developing estimates of the treatment costs and cost-effectiveness of Standard Methadone and BDRC (Specific Aim 2 of the proposes study), and providing training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers an clinical training for health professionals in China (Specific Aim 3 of the proposed study). Specific aims of the China project: Conduct a preliminary evaluation of the feasibility, acceptability, and preliminary efficacy for increasing treatment retention and reducing drug use and HIV risk behaviors of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) when combined with Standard Methadone, in comparison to Standard Methadone, among opiate dependent treatment seeking volunteers admitted to the Wuhan Methadone Clinic. Develop estimates of the costs and cost-effectiveness of Standard Methadone and BDRC. Train and provide ongoing clinical supervision to a core group of 10 drug counseling staff and provide additional mentoring in drug abuse and HIV risk reduction research to investigators in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, HIV Infections
Keywords
drug counseling, HIV risks, methadone maintenance, HIV Seronegativity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Methadone maintenance treatment with Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Methadone maintenance treatment with standard drug counseling
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
Intervention Description
once weekly individual counseling
Intervention Type
Behavioral
Intervention Name(s)
Drug counseling
Intervention Description
individual drug counseling
Primary Outcome Measure Information:
Title
Reductions of illicit opiate use
Time Frame
6 months
Title
Reductions in HIV risk behaviors
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: opioid dependence Exclusion Criteria: current dependence on alcohol, benzodiazepines or sedatives current suicide or homicide risk current psychotic disorder or untreated major depression life-threatening or unstable medical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Schottenfeld, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine - CMHC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Wuhan Center for Disease Control and Prevention
City
Wuhan
State/Province
Hubei
Country
China

12. IPD Sharing Statement

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Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China

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