Status:
COMPLETED
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
Lead Sponsor:
Pear Therapeutics, Inc.
Collaborating Sponsors:
Kaiser Foundation Research Institute
Whitman-Walker Institute, Inc.
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05412966
Start Date
November 4 2022
End Date
December 16 2022
Last Update
January 9 2023
Active Locations (1)
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1
Hassman Research Institute, LLC
Berlin, New Jersey, United States, 08009