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Braun S, Luderer H, Enman N, Gerwien R, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y
A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study
A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients with Opioid Use Disorder: Protocol for a Feasibility Study
Stephen Braun;
Hilary Luderer;
Nicole Enman;
Robert Gerwien;
Samantha McStocker;
Xiaorui Xiong;
Carrington Koebele;
Christopher Cannon;
Joseph Glass;
Yuri Maricich
ABSTRACT
Background:
Home-based (unsupervised) buprenorphine initiation is considered safe and effective, yet many patients report barriers to successful buprenorphine treatment initiation. Prescription digital therapeutics (PDTs) are software-based disease treatments regulated by the U.S. Food and Drug Administration (FDA). The reSET-O® PDT was FDA-authorized in 2018 and delivers behavioral treatment for individuals receiving buprenorphine for opioid use disorder (OUD). A prototype PDT (PEAR-002b) designed for use with reSET-O was developed with novel features that assist in unsupervised buprenorphine initiation. A digital buprenorphine initiation tool has the potential to improve the patient experience and better support prescribers during this high-touch process, thereby improving access and adherence to buprenorphine MOUD.
Objective:
The primary objective of this pilot study is to evaluate acceptability, unsupervised buprenorphine initiation success rate, and medication adherence in patients with OUD who use PEAR-002b to support buprenorphine initiation.
Methods:
Ten adults with OUD will be recruited for acceptability and feasibility testing. Outcomes will be assessed using week one visit attendance, participant interviews and satisfaction surveys, and urine drug screens.
Results:
This project was funded in September 2019. As of September 2022, participant enrollment is ongoing.
Conclusions:
This is the first study to our knowledge to develop a PDT that assists with unsupervised buprenorphine initiation with the intent to better support patients and prescribers during this early phase of treatment. This pilot study will assess the acceptability and utility of a digital therapeutic to assist patients with OUD with unsupervised buprenorphine initiation. Clinical Trial: ClinicalTrials.gov Identifier: NCT05412966
Citation
Please cite as:
Braun S, Luderer H, Enman N, Gerwien R, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y
A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study