Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study

Irene Pericot-Valverde, Angelica Perez, Moonseong Heo, Ashley Coleman, Erik Ortiz, Krupa Merchant, Trish Melling, Alain Litwin, Irene Pericot-Valverde, Angelica Perez, Moonseong Heo, Ashley Coleman, Erik Ortiz, Krupa Merchant, Trish Melling, Alain Litwin

Abstract

Background: Opioid use disorder (OUD) has led to a staggering death toll in terms of drug-related overdoses. Despite the demonstrated benefits and effectiveness of buprenorphine, retention is suboptimal, and patients typically present with high rates of ongoing polysubstance use during treatment. A pilot trial provided preliminary support for the efficacy of computer-based cognitive-behavioral therapy (CBT4CBT) as an add-on to buprenorphine in reducing substance use. Recovery coaching services provided by individuals with substance use experience and successful recovery have also shown to positively influence recovery outcomes for people with OUD by increasing buprenorphine initiation and reducing opioid use.

Methods: The OVERCOME study is a randomized clinical trial (RCT) aimed to tests an integrated intervention combining CBT4CBT and Recovery Coaching relative to treatment-as-usual (TAU) among individuals with OUD on buprenorphine. The primary outcome measure is the percentage of samples with any drug tested as positive at each research visit conducted during treatment (visits 1 to 8). Secondary outcomes include the percentage of samples with any drug tested as positive at 1- and 3- month follow-up and retention to buprenorphine at 3- month follow-up.

Results: We describe the rationale, design, and methodology of the OVERCOME Study.

Conclusion: This trial will provide evidence of the efficacy of an integrated intervention combining CBT4CBT and Recovery Coaching for reducing substance use and increasing buprenorphine adherence which has the potential to reduce mortality among people with OUD.

Keywords: Buprenorphine; CBT4CBT; Opioid use disorder; Recovery coaching.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work presented in this manuscript.

© 2022 Published by Elsevier Inc.

Figures

Fig. 1
Fig. 1
Flow Diagram Intention-to-treat (ITT) sample includes all randomly assigned participants. Modified Intention-to-treat (Mitt) sample includes participants who were randomly assigned, opened at least one CBT4CBT module and meet at least once with the recovery coach at initiated treatment. Per-Protocol (PP) sample includes participants who were randomly assigned who opened at least one CBT4CBT module and completed 50%, and meet at least once with the recovery coach.

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