Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
NCT ID: NCT05412966
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2022-11-04
2022-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEAR-002B / reSET-O
Digital Therapeutic
PEAR-002B
PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
reSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
Interventions
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PEAR-002B
PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
reSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kaiser Foundation Research Institute
OTHER
Whitman-Walker Institute, Inc.
OTHER_GOV
National Institute on Drug Abuse (NIDA)
NIH
Hassman Research Institute, LLC
UNKNOWN
Pear Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Hassman
Role: STUDY_DIRECTOR
Hassman Research Institute, LLC
Locations
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Hassman Research Institute, LLC
Berlin, New Jersey, United States
Countries
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References
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Luderer H, Enman N, Gerwien R, Braun S, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y. A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122.
Other Identifiers
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PEAR-002-101
Identifier Type: -
Identifier Source: org_study_id
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