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Journal of Addiction
Volume 2019, Article ID 2491063, 11 pages
https://doi.org/10.1155/2019/2491063
Clinical Study

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management

1Addictions Department, Institute of Psychiatry, Psychology and Neurosciences, King’s College London, 4-Windsor Walk, ASB, Denmark Hill, SE5 8BB, London, UK
2National Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE
3College of Medicine and Health Sciences, United Arab Emirates University, P.O. Box 15551, Alain, AD, UAE
4Addictions Department, Institute of Psychiatry, Psychology and Neurosciences, King’s College London, Addiction Sciences Building, 4 Windsor Walk, Demark Hill, London, Denmark Hill, SE5 8AF, UK

Correspondence should be addressed to Hesham Elarabi; ku.ca.lck@ibarale.mahseh

Received 11 September 2018; Revised 10 December 2018; Accepted 18 February 2019; Published 5 March 2019

Academic Editor: Angela L. Stotts

Copyright © 2019 Hesham Elarabi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Introduction. Opioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment under this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses contingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM) alongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence with BUP but it has not been applied in OAT programs and evaluation research to date. Methods. The Suboxone Treatment and Recovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine the effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient OAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone™]) to receive stepped take-home doses. Following stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1) BUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the experimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group). The primary outcome is the mean percentage of negative UDS over 16 weeks. The secondary outcome is treatment retention defined as completion of 16 weeks of OAT without interruption. There will be an exploratory analysis of the association between participant characteristics, clinical data, and outcomes. Conclusions. Providing BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT to be delivered flexibly and effectively. Trial Registration. ISRCTN41645723 is retrospectively registered on 15/11/2015.