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

NCT ID: NCT00539123

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-08-31

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.

Detailed Description

Heroin and injection drug use (IDU) are highly prevalent and driving the HIV epidemic in Malaysia and other countries in the region. In our original RCT, buprenorphine was superior to naltrexone and placebo in treatment retention, weeks of consecutive abstinence and time to heroin use. However, there is room for improvement, since only 50% of subjects assigned to buprenorphine and counseling remained in treatment for 6 months; only 28% avoided relapse to heroin; and treatment reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S. buprenorphine treatment effectiveness may be even less, because buprenorphine is provided with relatively minimal psychosocial services (often brief physician management (PM) alone, without additional counseling), and without additional behavioral interventions or contingency management. Hence, we propose a follow up study to evaluate whether standard buprenorphine treatment (consisting of buprenorphine provision, PM, and non-contingent provision of take-home doses of buprenorphine, NCB) is sufficient or whether one or a combination of two behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve its efficacy. 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. ACB, a low cost and feasible alternative to non-contingent take-home buprenorphine (NCB), retains many of its advantages--abstinent patients manage their medication supplies outside of the clinic--but ACB also provides positive incentives for abstinence and directly observed buprenorphine for those with continuing heroin use. In the proposed 2X2 study, heroin dependent patients (N=240) will be inducted onto buprenorphine (weeks 1-2) and then randomized to PM with NCB, PM with ACB, PM with BDRC and NCB, or PM with BDRC and ACB (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests) and reductions in drug- and sex-related HIV risk behaviors. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

Conditions

Opiate Dependence

Study Design

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

Study Groups

NCB

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

Group Type: EXPERIMENTAL

behavioral drug and HIV risk reduction counseling (BDRC)

Intervention Type: 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.

ACB

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

Group Type: EXPERIMENTAL

abstinence-contingent buprenorphine (ACB)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

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 major depression inability to understand protocol or assessment questions life threatening or unstable medical problems more than 3x normal liver enzymes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Responsibility Role: SPONSOR

Principal Investigators

Richard S. Schottenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Mahmud Mazlan, MD

Role: STUDY_DIRECTOR

Substance Abuse Research Center, Muar

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Substance Abuse Research Center

Muar town, Johor, Malaysia

Countries

United States; Malaysia

Other Identifiers

R01DA014718-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0506000082

Identifier Type: -

Identifier Source: org_study_id