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

NCT ID: NCT00757744

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-09-30

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:

1. 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.

2. Develop estimates of the costs and cost-effectiveness of Standard Methadone and BDRC.

3. 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.

Conditions

Opiate Dependence; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

Intervention Type: BEHAVIORAL

once weekly individual counseling

B

Methadone maintenance treatment with standard drug counseling

Group Type: ACTIVE_COMPARATOR

Drug counseling

Intervention Type: BEHAVIORAL

individual drug counseling

Interventions

Behavioral Drug and HIV Risk Reduction Counseling (BDRC)

once weekly individual counseling

Intervention Type: BEHAVIORAL

Drug counseling

individual drug counseling

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Yale University School of Medicine

Principal Investigators

Richard S Schottenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine - CMHC

New Haven, Connecticut, United States

Wuhan Center for Disease Control and Prevention

Wuhan, Hubei, China

Countries

United States; China

Other Identifiers

R01DA014718-05A1S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0709003081

Identifier Type: -

Identifier Source: org_study_id