Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Device: PEAR-002B; Device: reSET-O

• Registration Number: NCT05412966
• Lead Sponsor: Pear Therapeutics, Inc.

Brief Summary

The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.

Detailed Description

The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.

This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.

This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2022-11-04
• Primary Completion: 2022-11-23
• Study Completion: 2022-12-16
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Provide written informed consent prior to any study specific assessments being performed
2. Male or female ≥18 years of age, inclusive
3. English proficiency to meaningfully participate in consent process, assessment and intervention
4. Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
5. Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
6. Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)
7. Interested in testing or using PEAR-002b
8. No prior history of reSET-O use
9. Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment
10. Is considered appropriate for participation by their clinician

Exclusion Criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
2. DSM-5 diagnosis of OUD and already on buprenorphine
3. Planning to move out of the geographic area within 2 months
4. Unable to use English to participate in the consent process, the interventions, or assessments
5. Inability to comply with study procedures, due to severe medical conditions or otherwise
6. Currently receiving inpatient treatment for OUD
7. Women who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEAR-002B / reSET-O	PEAR-002B	Digital Therapeutic
PEAR-002B / reSET-O	reSET-O	Digital Therapeutic

Primary Outcome Measures

Name	Time	Method
PEAR-002B User Satisfaction Surveys	Week 1	Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints
PEAR-002B Qualitative User Experience Interviews	Week 1	Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Buprenorphine Initiation Success	Week 1	Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Medication Adherence Rates	From Week 1 to Week 4	Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine

Secondary Outcome Measures

Name	Time	Method
PEAR-002B Engagement Data	From Baseline to Week 1	PEAR-002B engagement rates as measured by participant use patterns data
reSET-O Qualitative User Experience Interviews	Week 4	Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
reSET-O User Satisfaction Surveys	Week 4	Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints

Trial Locations

Locations (1)

Hassman Research Institute, LLC; 🇺🇸 Berlin, New Jersey, United States