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Inventi Impact: Clinical Research

Articles

  • Inventi:pcr/29312/19
    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
    Research 2019 : July - September
    Hesham Elarabi, Abuelgasim Elrasheed, Ahmed Ali, Mansour Shawky, Nael Hasan, Tarek A Gawad, Abdu Adem, John Marsden

    Introduction. Opioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for\nillicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for selfadministration.\nThis provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence\nor medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment\nunder this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses\ncontingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM)\nalongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence\nwith BUP but it has not been applied in OAT programs and evaluation research to date. Methods. The Suboxone Treatment and\nRecovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine\nthe effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient\nOAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone(TM)]) to receive stepped take-home doses.\nFollowing stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1)\nBUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the\nexperimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group).The primary outcome is the mean\npercentage of negativeUDS over 16 weeks. Thesecondary outcome is treatment retention defined as completion of 16 weeks ofOAT\nwithout interruption.There will be an exploratory analysis of the association between participant characteristics, clinical data, and\noutcomes. Conclusions. Providing BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT\nto be delivered flexibly and effectively. Trial Registration. ISRCTN41645723 is retrospectively registered on 15/11/2015.

    How to Cite this Article
    Attribution/ CC Compliant Citation: Elarabi, Hesham, et al;\nSuboxone Treatment and Recovery Trial (STAR-T): Study Protocol\nfor a Randomised Controlled Trial of Opioid Medication Assisted\nTreatment with Adjunctive Medication Management Using\nTherapeutic Drug Monitoring and Contingency Management;\nJournal of Addiction 2019 (2019).\nhttps://doi.org/10.1155/2019/2491063\nhttp://creativecommons.org/licenses/by/4.0/\n\nSome formatting elements, header, footer, logos, dates and\npagination were modified while adapting this article.
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