Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.
| Autor: | Maricich YA; Pear Therapeutics, Inc., Boston, MA, USA., Bickel WK; Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA., Marsch LA; Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA., Gatchalian K; Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA., Botbyl J; Provonix, Sewell, NJ, USA., Luderer HF; Pear Therapeutics, Inc., Boston, MA, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Current medical research and opinion [Curr Med Res Opin] 2021 Feb; Vol. 37 (2), pp. 167-173. Date of Electronic Publication: 2020 Dec 07. |
| DOI: | 10.1080/03007995.2020.1846022 |
| Abstrakt: | 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 170 adults 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 min 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 =.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= .42). Conclusions: A prescription digital therapeutic (PDT) 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: | MEDLINE |
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