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

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

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

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: reSET-O; Device: PEAR-002B

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence From Illicit Opioids	Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids.	From Baseline to Week4
Treatment Retention	Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method	From Baseline to Week 4
Device Wearing Time	Device wearing time as measured by EmbracePlus wearable device data	From Baseline to Week 4
Physiological Biomarker Data	Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device	From Baseline to Week 4

Collaborators and Investigators

• Sponsor: Pear Therapeutics, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Kaiser Foundation Research Institute; Whitman-Walker Institute, Inc.; Hassman Research Institute, LLC
• Investigators: Study Director: Michael Hassman, Hassman Research Institute, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: digital therapeutic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: PEAR-002-101; R44DA049493 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No