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Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

NCT00539123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2021-06-18

No results posted yet for this study

Summary

A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for opiate-dependent individuals in Malaysia.

Conditions

  • Opiate Dependence

Interventions

BEHAVIORAL

behavioral drug and HIV risk reduction counseling (BDRC)

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 Malaysia.

BEHAVIORAL

abstinence-contingent buprenorphine (ACB)

Participants achieving heroin abstinence documented by an opioid-negative urine test receive take-home doses of buprenorphine-naloxone, with the number of take-home doses permitted increasing depending on the number of consecutive opioid-negative urine tests. Participants who test positive receive all doses of buprenorphine-naloxone under direct observation in the clinic, using a three-times per week dosing protocol.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Richard S. Schottenfeld, MD · Yale University

  • Mahmud Mazlan, MD · Substance Abuse Research Center, Muar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-08-31
Completion
2012-08-31

Countries

  • United States
  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539123 on ClinicalTrials.gov