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

Primary Purpose

Opioid Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEAR-002B
reSET-O
Sponsored by
Pear Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring digital therapeutic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hassman Research Institute, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEAR-002B / reSET-O

Arm Description

Digital Therapeutic

Outcomes

Primary Outcome Measures

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
PEAR-002B Qualitative User Experience Interviews
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Buprenorphine Initiation Success
Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Medication Adherence Rates
Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine

Secondary Outcome Measures

PEAR-002B Engagement Data
PEAR-002B engagement rates as measured by participant use patterns data
reSET-O Qualitative User Experience Interviews
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
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

Full Information

First Posted
May 19, 2022
Last Updated
January 5, 2023
Sponsor
Pear Therapeutics, Inc.
Collaborators
Kaiser Foundation Research Institute, Whitman-Walker Institute, Inc., National Institute on Drug Abuse (NIDA), Hassman Research Institute, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05412966
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pear Therapeutics, Inc.
Collaborators
Kaiser Foundation Research Institute, Whitman-Walker Institute, Inc., National Institute on Drug Abuse (NIDA), Hassman Research Institute, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
digital therapeutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEAR-002B / reSET-O
Arm Type
Experimental
Arm Description
Digital Therapeutic
Intervention Type
Device
Intervention Name(s)
PEAR-002B
Intervention Description
PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
Intervention Type
Device
Intervention Name(s)
reSET-O
Intervention Description
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
Primary Outcome Measure Information:
Title
PEAR-002B User Satisfaction Surveys
Description
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
Time Frame
Week 1
Title
PEAR-002B Qualitative User Experience Interviews
Description
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Time Frame
Week 1
Title
Buprenorphine Initiation Success
Description
Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Time Frame
Week 1
Title
Medication Adherence Rates
Description
Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine
Time Frame
From Week 1 to Week 4
Secondary Outcome Measure Information:
Title
PEAR-002B Engagement Data
Description
PEAR-002B engagement rates as measured by participant use patterns data
Time Frame
From Baseline to Week 1
Title
reSET-O Qualitative User Experience Interviews
Description
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Time Frame
Week 4
Title
reSET-O User Satisfaction Surveys
Description
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
Time Frame
Week 4
Other Pre-specified Outcome Measures:
Title
Abstinence From Illicit Opioids
Description
Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids.
Time Frame
From Baseline to Week4
Title
Treatment Retention
Description
Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method
Time Frame
From Baseline to Week 4
Title
Device Wearing Time
Description
Device wearing time as measured by EmbracePlus wearable device data
Time Frame
From Baseline to Week 4
Title
Physiological Biomarker Data
Description
Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device
Time Frame
From Baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hassman
Organizational Affiliation
Hassman Research Institute, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Hassman Research Institute, LLC
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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