NCT00539123

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3.9 years

First QC Date

October 2, 2007

Last Update Submit

June 11, 2021

Conditions

Opiate Dependence

Keywords

buprenorphinedrug counselingHIV risk reduction counseling

Outcome Measures

Primary Outcomes (2)

  • reductions in heroin use

    26 weeks

  • reductions in drug- and sex-related HIV risk

    26 weeks

Secondary Outcomes (3)

  • retention

    26 weeks

  • reductions in other illicit drug use

    26 weeks

  • changes in functional status

    26 weeks

Study Arms (2)

NCB

EXPERIMENTAL

Participants receive Physician Management (PM) and non-contingent provision of take-home doses of buprenorphine-naloxone (NCB).

Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)

ACB

EXPERIMENTAL

Participants receive Physician Management (PM) and abstinence-contingent provision of take-home doses of buprenorphine-naloxone (ACB).

Behavioral: abstinence-contingent buprenorphine (ACB)

Interventions

behavioral drug and HIV risk reduction counseling (BDRC)BEHAVIORAL

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.

NCB
abstinence-contingent buprenorphine (ACB)BEHAVIORAL

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.

ACB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opioid dependence

You may not qualify if:

  • current dependence on alcohol, benzodiazepines or sedatives current suicide or homicide risk current psychotic disorder or major depression inability to understand protocol or assessment questions life threatening or unstable medical problems more than 3x normal liver enzymes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Substance Abuse Research Center

Muar town, Johor, 84000, Malaysia

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Richard S. Schottenfeld, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Mahmud Mazlan, MD

    Substance Abuse Research Center, Muar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2x2 factorial design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

MY(1)US(1)