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

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.

Study Overview

• Status: Completed
• Conditions: Opiate Dependence
• Intervention / Treatment: Behavioral: behavioral drug and HIV risk reduction counseling (BDRC); Behavioral: abstinence-contingent buprenorphine (ACB)

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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Johor
    • Muar, Johor, Malaysia, 84000
      • Substance Abuse Research Center
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NCB; 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); 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.
Experimental: ACB; Participants receive Physician Management (PM) and abstinence-contingent provision of take-home doses of buprenorphine-naloxone (ACB).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reductions in heroin use	26 weeks
reductions in drug- and sex-related HIV risk	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
retention	26 weeks
reductions in other illicit drug use	26 weeks
changes in functional status	26 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Richard S. Schottenfeld, MD, Yale University; Study Director: Mahmud Mazlan, MD, Substance Abuse Research Center, Muar

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (Estimate): October 4, 2007

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: buprenorphine; HIV risk reduction counseling; drug counseling
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 0506000082; R01DA014718-05A1 (U.S. NIH Grant/Contract)