Feasibility and Acceptability of reSET-O®: Patient and Provider Reported Experiences in a Pilot Study of a Novel Digital Therapeutic in People with Opioid Use Disorder (Preprint)
BACKGROUND Medications for treatment of opioid use disorder (OUD), such as buprenorphine, are effective and essential for addressing the opioid epidemic. However, high dropout rates from medication remain a challenge. Behavioral treatment with contingency management plus cognitive behavioral counseling has shown promise for improving outcomes of buprenorphine treatment, but is complicated to deliver. Delivery of behavioral treatment through technology-based platforms has the potential to make it more feasible for widespread dissemination. OBJECTIVE reSET-O® is a Prescription Digital Therapeutic and a commercial adaptation of the Therapeutic Education System, an internet-based, interactive program with a Community Reinforcement Approach to cognitive behavioral therapy. It delivers cognitive behavioral therapy modules and contingency management rewards upon completion of modules and negative urine drug screens. A pilot study was performed to assess feasibility and acceptability of reSET-O® in a Hub and Spoke model of care as part of a larger strategy to maintain individuals in treatment. Objective and qualitative results, as well as acceptability and likeability of reSET-O®, were obtained from fifteen individuals. METHODS English-speaking individuals over the age of 18 with a diagnosis of current OUD were recruited after being on buprenorphine for at least one week of treatment. Two 12-week prescriptions for reSET-O® were written for a 24-week study. Patient report of drug use and likeability scales of reSET-O® were conducted at weeks 4,8, 12 and 24 of the study. Qualitative interviews were also conducted. Four providers were recruited and gave feedback on the acceptability and feasibility of reSET-O®. RESULTS Of 15 participants who entered this pilot study, 7 completed 24 weeks and 8 were unable to complete due to drop out after enrollment, attrition in treatment, or incarceration. An average of $96 in contingency management rewards were earned by the participants for completion of modules for the duration of the pilot study. Participants’ subjective feedback found that reSET-O® was easy to use, enjoyable, and helped provide a safe space to admit recurring substance use. CONCLUSIONS ReSET-O® was well accepted based on patient and provider feedback in this pilot study, but adherence and retention in treatment remain areas for improvement, as with traditional MOUD and CBT approaches. A randomized control trial in a Hub and Spoke model will be needed to assess if retention on buprenorphine treatment is enhanced through the use of technology based behavioral interventions such as reSET-O®. CLINICALTRIAL NCT03826966