ArticleContemporary clinical trials2026
Rationale and design of a three-arm randomized clinical trial to improve drug use and retention in care of people with opioid use disorder on buprenorphine: OVERCOME II study.
Article in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06102200 (Prisma Health Clemson University), which is not on this map. Not yet cited in PubMed.
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Prisma Health Clemson University
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Abstract
Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT) and utilization of recovery coaches (RCs), called RC + CBT4CBT-Buprenorphine, into OUD care could improve drug use and retention in care among patients taking buprenorphine. The OVERCOME II (OUD Intervention Recovery Coach CBT and OUD Medications II) study is a three-arm 1:1:1 randomized clinical trial designed to test the remotely delivered RC + CBT4CBT-Buprenorphineintervention as an adjunct to buprenorphine treatment for patients with OUD, and to compare it with both CBT4CBT-Buprenorphine alone and the treatment as usual (TAU). Patients (n = 90) who have newly initiated buprenorphine in the past 90 days are planned to be recruited. Comprehensive measures on demographics, various conditions/constructs, and outcomes will be collected from medical charts and survey instruments. Additionally, neurophysiological outcomes and neurocognitive inhibitory controls will be measured using the NEXUS-10-MKII physiological system with BioTrace+ software and computerized Drug Go/NoGo Task, respectively. Qualitative analysis of interviews with N = 2 RCs and N = 15 participants will also be conducted. The study will be the first to examine the effectiveness of the remotely delivered RC + CBT4CBT-Buprenorphine intervention on drug use (during the first 8 weeks and follow-up) and retention in care, as well as on various neurophysiological and cognitive performances in comparison to CBT4CBT-Buprenorphine alone and TAU. Clinical Trial Registration: This study was registered at ClinicalTrials.gov (NCT06102200, www.clinicaltrials.gov/) on August 31, 2023, with a title, An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2).
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