Clinical trial NCT05412966: Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
Official title: A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: digital therapeutic
Lead sponsor: Pear Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Foundation Research Institute
name: Whitman-Walker Institute, Inc.
name: National Institute on Drug Abuse (NIDA)
name: Hassman Research Institute, LLC
First posted: 2022-06-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: PEAR-002B User Satisfaction Surveys
timeFrame: Week 1
measure: PEAR-002B Qualitative User Experience Interviews
timeFrame: Week 1
measure: Buprenorphine Initiation Success
timeFrame: Week 1
measure: Medication Adherence Rates
timeFrame: From Week 1 to Week 4
Secondary outcomes:
measure: PEAR-002B Engagement Data
timeFrame: From Baseline to Week 1
measure: reSET-O Qualitative User Experience Interviews
timeFrame: Week 4
measure: reSET-O User Satisfaction Surveys
timeFrame: Week 4
Other outcomes:
measure: Abstinence From Illicit Opioids
timeFrame: From Baseline to Week4
measure: Treatment Retention
timeFrame: From Baseline to Week 4
measure: Device Wearing Time
timeFrame: From Baseline to Week 4
measure: Physiological Biomarker Data
timeFrame: From Baseline to Week 4
Locations:
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
Study officials:
affiliation: Hassman Research Institute, LLC
name: Michael Hassman
role: STUDY_DIRECTOR
References: