Behavioral Counseling and Abstinence-Contingent Take-Home Buprenorphine in Malaysia: A Randomized, Open Label Trial

Abstract

Background: Buprenorphine-naloxone treatment provided by primary care physicians, often with minimal behavioral interventions, has greatly expanded access to medical treatment for opioid dependence. We evaluated whether additional behavioral interventions improve treatment outcomes with buprenorphine-naloxone provided by general medical practitioners in Malaysia. Methods: This randomized, open-label, clinical trial used a 2x2 factorial study design to evaluate the two factors: 1) Physician Management with or without additional Behavioral Counseling and 2) abstinence-contingent or non-contingent provision of take-home doses of buprenorphine-naloxone (ACB or NCB). Participants with opioid dependence were randomly assigned by an investigator in the U.S. to one of four treatment conditions resulting from 2x2 factorial study design and treated with buprenorphine-naloxone and Physician Management for 24 weeks by one of two general practitioners in Muar, Malaysia. Participants, investigators, and outcome assessors were not masked to group assignment. Primary outcomes assessed during the 24-week study were proportions of opioid-negative urine tests and HIV risk behaviors (assessed by Audio Computer Assisted AIDS Risk Inventory) and evaluated for all randomized participants. Findings: Between August 30, 2007, and August 15, 2011, 234 participants, all male, were enrolled and randomized. The rates of opioid negative urine tests were significantly higher with Behavioral Counseling (68·2%, 95% CI 65·2-71·2%) than without Behavioral Counseling (59·2%, 95% CI 56·3-62·2, p<0·001) and with ACB (71·0%, 95% CI 68·0-74·0) than with NCB (56·4%, 95% CI 53·4-59·4, p<0·001). Scores on ACASI-ARI decreased significantly from baseline across all treatment groups (p <0·001) but did not differ significantly with or without Behavioral Counseling (p=·099) or ACB (p=·339). Interpretation: Provision of Behavioral Counseling or ACB with buprenorphine-naloxone and Physician Management resulted in greater reductions of opioid use as compared to Physician Management without Behavioral Counseling or NCB. Both interventions may enhance the effectiveness of buprenorphine-naloxone treatment in primary care medical settings. Clinical Trial Number: This trial is registered with ClinicalTrials.gov, number NCT00539123. Funding Statement: The study was funded by the National Institute on Drug Abuse; two investigators (RS and MC) also receive support from the State of Connecticut Department of Mental Health and Addiction Services. The funding agencies did not have any role in the study design; the collection, analysis, and interpretation of data; the writing of the report; or the decision to submit the paper for publication. Medications were provided free of charge from the manufacturer, Reckitt Benckiser Pharma. Declaration of Interests: None of the authors has any competing interests. Ethics Approval Statement: The study was approved by the Human Investigation Committee, Yale University, and the Malaysian Ministry of Health Human Subjects Review Board. There were no changes to the study design or outcomes following the start of the study.