PMID- 36662568 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240214 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 12 DP - 2023 Jan 20 TI - A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. PG - e43122 LID - 10.2196/43122 [doi] LID - e43122 AB - 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 individuals receiving buprenorphine for opioid use disorder (OUD). A prototype PDT (PEAR-002b) designed for use with reSET-O was developed to assist in unsupervised buprenorphine initiation. OBJECTIVE: The primary objective of this pilot study is to evaluate the acceptability of PEAR-002b in individuals with OUD who use it to support buprenorphine initiation, their unsupervised buprenorphine initiation success rate, and their medication adherence. METHODS: Ten adults with OUD will be recruited for acceptability and feasibility testing. Outcomes will be assessed using week-1 visit attendance, participant interviews and satisfaction surveys, and urine drug screening (UDS). Three tools will be used in the study: PEAR-002b, reSET-O, and EmbracePlus. PEAR-002b includes a new set of features designed for use with reSET-O. The mechanism of action for the combined PEAR-002b and reSET-O treatment is a program of medication dosing support during week 1 of the initiation phase, cognitive behavioral therapy, and contingency management. During the medication initiation phase, participants are guided through a process to support proper medication use. PEAR-002b advises them when to take their buprenorphine based on provider inputs (eg, starting dose), self-reported substance use, and self-reported withdrawal symptoms. This study also administers the EmbracePlus device, a medical-grade smartwatch, to pilot methods for collecting physiologic data (eg, heart rate and skin conductance) and evaluate the device's potential for use along with PDTs that are designed to improve OUD treatment initiation. Home buprenorphine initiation success will be summarized as the proportion of participants attending the post-buprenorphine initiation visit (week 1) and the proportion of participants who experience buprenorphine initiation-related adverse events (eg, precipitated withdrawal). Acceptability of PEAR-002b will be evaluated based on individual participants' ratings of ease of use, satisfaction, perceived helpfulness, and likelihood of recommending PEAR-002b. Medication adherence will be evaluated by participant self-report data and confirmed by UDS. UDS data will be summarized as the mean of individual participants' proportion of total urine samples testing positive for buprenorphine or norbuprenorphine over the 4-week study. 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 individuals with OUD with unsupervised buprenorphine initiation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05412966; https://clinicaltrials.gov/ct2/show/NCT05412966. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43122. CI - (c)Hilary Luderer, Nicole Enman, Robert Gerwien, Stephen Braun, Samantha McStocker, Xiaorui Xiong, Carrington Koebele, Christopher Cannon, Joseph Glass, Yuri Maricich. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.01.2023. FAU - Luderer, Hilary AU - Luderer H AUID- ORCID: 0000-0002-3737-946X AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - Enman, Nicole AU - Enman N AUID- ORCID: 0000-0002-3925-1603 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - Gerwien, Robert AU - Gerwien R AUID- ORCID: 0000-0001-8368-5188 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - Braun, Stephen AU - Braun S AUID- ORCID: 0000-0001-9891-3825 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - McStocker, Samantha AU - McStocker S AUID- ORCID: 0000-0001-8662-2983 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - Xiong, Xiaorui AU - Xiong X AUID- ORCID: 0000-0001-7838-4524 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. FAU - Koebele, Carrington AU - Koebele C AUID- ORCID: 0000-0002-6795-295X AD - Whitman-Walker Institute, Washington, DC, United States. FAU - Cannon, Christopher AU - Cannon C AUID- ORCID: 0000-0003-1937-4283 AD - Whitman-Walker Institute, Washington, DC, United States. FAU - Glass, Joseph AU - Glass J AUID- ORCID: 0000-0002-2923-3698 AD - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States. FAU - Maricich, Yuri AU - Maricich Y AUID- ORCID: 0000-0001-8667-5233 AD - Pear Therapeutics (US), Inc, Boston, MA, United States. LA - eng SI - ClinicalTrials.gov/NCT05412966 GR - R44 DA042652/DA/NIDA NIH HHS/United States GR - R44 DA049493/DA/NIDA NIH HHS/United States PT - Journal Article DEP - 20230120 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC9898828 OTO - NOTNLM OT - OUD OT - PDT OT - buprenorphine OT - digital health intervention OT - digital therapeutics OT - medication adherence OT - opioid use disorder OT - prescription digital therapeutic OT - reSET-O OT - unsupervised buprenorphine initiation COIS- Conflicts of Interest: HL, RG, SM, XX, YM, and SB are consultants or employees of Pear Therapeutics (US), Inc. NE was an employee of Pear Therapeutics (US), Inc at the time this manuscript was written. Pear Therapeutics Inc provided digital therapeutic prescriptions at no cost to Kaiser Permanente Washington during a quality improvement pilot study that was led by JG. JG is a coinvestigator on a grant proposal awarded to Pear Therapeutics Inc by the National Institute on Drug Abuse, which evaluates potential improvements to reSET-O (R44DA042652). Pear Therapeutics does not provide funding to JG. EDAT- 2023/01/21 06:00 MHDA- 2023/01/21 06:01 PMCR- 2023/01/20 CRDT- 2023/01/20 11:54 PHST- 2022/09/30 00:00 [received] PHST- 2022/12/13 00:00 [accepted] PHST- 2022/12/12 00:00 [revised] PHST- 2023/01/20 11:54 [entrez] PHST- 2023/01/21 06:00 [pubmed] PHST- 2023/01/21 06:01 [medline] PHST- 2023/01/20 00:00 [pmc-release] AID - v12i1e43122 [pii] AID - 10.2196/43122 [doi] PST - epublish SO - JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122.