Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder
| Autor: | Warren K. Bickel, Jeffrey Botbyl, Yuri A. Maricich, Kirstin M. Gatchalian, Hilary F. Luderer, Lisa A. Marsch |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty 030204 cardiovascular system & hematology Drug Administration Schedule Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Humans 030212 general & internal medicine Medical prescription Intensive care medicine business.industry Opioid use disorder General Medicine medicine.disease Opioid-Related Disorders Adjunct Buprenorphine Substance abuse Prescriptions Safety business medicine.drug |
| Zdroj: | Curr Med Res Opin |
| ISSN: | 1473-4877 |
| Popis: | OBJECTIVES: To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253). METHODS: Secondary analysis of an RCT including 170adults meeting DSM-IV criteria for OUD. Participants were randomized to 12-weeks of treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach. TAU consisted of buprenorphine maintenance therapy, 30 minutes biweekly clinician interaction, and abstinence-based contingency management. Primary endpoints were treatment retention and abstinence (negative urine drug screen) during weeks 9–12 of treatment. Safety was assessed by evaluating adverse events. RESULTS: Participants randomized to TAU plus a digital therapeutic had significantly greater odds of opioid abstinence during weeks 9–12 compared to TAU: 77.3% versus 62.1% respectively (P=0.02), OR 2.08, 95% CI 1.10–3.95. The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26–0.92). No significant difference was observed in the rate of adverse events between groups (P=0.42). CONCLUSIONS: A prescription digital therapeutic in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with treatment as usual. |
| Databáze: | OpenAIRE |
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