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

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

Detailed Description
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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.

Official Title
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A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Device: PEAR-002B
* Device: reSET-O


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to any study specific assessments being performed Male or female ≥18 years of age, inclusive English proficiency to meaningfully participate in consent process, assessment and intervention Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use) Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet) Interested in testing or using PEAR-002b No prior history of reSET-O use 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 Is considered appropriate for participation by their clinician Exclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy DSM-5 diagnosis of OUD and already on buprenorphine Planning to move out of the geographic area within 2 months Unable to use English to participate in the consent process, the interventions, or assessments Inability to comply with study procedures, due to severe medical conditions or otherwise Currently receiving inpatient treatment for OUD Women who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAR-002B / reSET-O<br>Digital Therapeutic | Device: PEAR-002B<br>* PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder<br>Device: reSET-O<br>* reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEAR-002B User Satisfaction Surveys | 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 | Week 1 | 
| PEAR-002B Qualitative User Experience Interviews | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes | Week 1 | 
| Buprenorphine Initiation Success | Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit | Week 1 | 
| Medication Adherence Rates | Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine | From Week 1 to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEAR-002B Engagement Data | PEAR-002B engagement rates as measured by participant use patterns data | From Baseline to Week 1 | 
| reSET-O Qualitative User Experience Interviews | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes | Week 4 | 
| reSET-O User Satisfaction Surveys | 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 | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital therapeutic