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Article History

Received: 3 September 2019

Accepted: 21 January 2020

First Online: 11 February 2020

Ethics approval and consent to participate

: Informed consent will be obtained from all study participants. The protocol, PIS, PCF and research questionnaires were approved by the East of England-Cambridge East Research Ethics Committee (reference: 17/EE/0454) and the Health Research Authority (Integrated Research Application System (IRAS) project number: 233276). The protocol was first approved by the Ethics Committee on 21 December 2017 and amended on 23 May 2018 to incorporate the independent process evaluation (version 1.0).

: Consent Forms for the trial include consent for publication of results in peer-reviewed journals.

: All authors have completed the uniform disclosure form of the International Committee of Medical Journal Editors ( ).In the past 3 years, JM declares research grants from the National Institute for Health Research (National Institute for Health Research (NIHR); randomised controlled trial of depot naltrexone for OUD, and a randomised controlled trial of acamprosate for AUD), and the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Mental Health Foundation Trust (SLaM; randomised controlled trial of novel cognitive therapy for cocaine use disorder). He has part-time employment as Senior Academic Advisor for the Alcohol, Drugs, Tobacco and Justice Division, Health Improvement Directorate, PHE and is a clinical academic consultant for the US National Institute on Drug Abuse, Centre for Clinical Trials Network. JM declares an unrestricted research grant at IoPPN and SLaM from Indivior via Action on Addiction for a randomised controlled trial of personalised psychosocial intervention in opioid-agonist medication for OUD (published in 2019) and from 2019 an unrestricted research grant funding at IoPPN and SLaM from Indivior for a 3-year, multi-centre, randomised controlled trial of injectable depot buprenorphine for OUD. He has received honoraria and travel support from Reckitt-Benckiser (2016; treatment of OUD) and PCM Scientific and Martindale for the Improving Outcomes in Treatment of Opioid Dependence Conference (2018).All other authors have no competing interests to declare.