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

NCT05412966 | Completed FDA Device

• 2 other identifiers: PEAR-002-101R44DA049493
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Use Disorder

Keywords

digital therapeutic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• PEAR-002B Engagement Data

  From Baseline to Week 1

• reSET-O Qualitative User Experience Interviews

  Week 4

• reSET-O User Satisfaction Surveys

  Week 4

Other Outcomes (4)

• Abstinence From Illicit Opioids

  From Baseline to Week4

• Treatment Retention

  From Baseline to Week 4

• Device Wearing Time

  From Baseline to Week 4

Study Arms (1)

PEAR-002B / reSET-O

EXPERIMENTAL

Digital Therapeutic

Device: PEAR-002B; Device: reSET-O

Interventions

PEAR-002B DEVICE

PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder

PEAR-002B / reSET-O

reSET-O DEVICE

reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.

PEAR-002B / reSET-O

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pear Therapeutics, Inc.: lead
• Kaiser Foundation Research Institute: collaborator
• Whitman-Walker Institute, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Hassman Research Institute, LLC: collaborator

Study Sites (1)

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

Location

Related Publications (1)

• 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.

  PMID: 36662568 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Hassman

  Hassman Research Institute, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 9, 2022
• Study Start: November 4, 2022
• Primary Completion: November 23, 2022
• Study Completion: December 16, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

US (1)