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Peer-Reviewed Publication
JMIR Res Protoc2023;12e43122.January 20, 2023Journal Article

A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study.

Hilary Luderer1, Nicole Enman1, Robert Gerwien1, Stephen Braun1, Samantha McStocker1, Xiaorui Xiong1, Carrington Koebele2, Christopher Cannon2, Joseph Glass3, Yuri Maricich1
1Pear Therapeutics (US), Inc, Boston, MA, United States.
2Whitman-Walker Institute, Washington, DC, United States.
3Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.

Abstract

BACKGROUND: Home-based (unsupervised) buprenorphine initiation is considered safe and effective, yet many patients report barriers to successful treatment initiation. Prescription digital therapeutics (PDTs) are software-based disease treatments regulated by the US Food and Drug Administration (FDA). The reSET-O PDT was authorized by the FDA in 2018 and delivers behavioral treatment for individual…

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