Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder

BACKGROUND: Buprenorphine-naloxone is an evidence-based treatment for Opioid Use Disorder. However, despite its efficacy, nearly half of participants are unsuccessful in achieving stabilization (i.e., period of time following medication induction in which medication dose is adjusted to be effective in reducing cravings/withdrawal, minimize potential side effects, and eliminate illicit substance use). This paper presents the study design and protocol for a digital health intervention designed to promote engagement in and adherence to buprenorphine treatment, offered through an outpatient addiction treatment center, through motivational enhancement and distress tolerance skills training. Personalized feedback interventions represent a promising method to effectively motivate engagement in and adherence to buprenorphine treatment. These interventions are generally brief, individually tailored, and have the potential to be delivered via mobile platforms. Distress tolerance, a transdiagnostic vulnerability factor, has been implicated in the development and maintenance of substance use. Targeting distress tolerance may improve substance use treatment outcomes by promoting the ability to persist in goal-directed activity even when experiencing physical or emotional distress. METHODS: The study aims are to: (1) develop and refine an interactive computer- and text message-delivered personalized feedback intervention that incorporates distress tolerance skills training for persons who have elected to initiate outpatient buprenorphine treatment (iCOPE); (2) examine the feasibility, acceptability, and preliminary efficacy of iCOPE for increasing abstinence, adherence, and retention in treatment compared to a treatment as usual comparison condition; and, (3) examine potential mechanisms that may underlie the efficacy of iCOPE in improving outcomes, including motivation, distress tolerance, self-regulation, and negative affect. DISCUSSION: Results of this study will be used to determine whether to proceed with further testing through a large-scale trial. This work has the potential to improve treatment outcomes by reducing illicit opioid use, increasing adherence/retention, and preventing future overdose and other complications of illicit opioid use. Trial Registration NCT03842384