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

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412966
• Other study ID #: PEAR-002-101
• Secondary ID: R44DA049493
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: January 2023
• Source: Pear Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 16, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Hassman Research Institute, LLC	Berlin	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
Pear Therapeutics, Inc.	Hassman Research Institute, LLC, Kaiser Foundation Research Institute, National Institute on Drug Abuse (NIDA), Whitman-Walker Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abstinence From Illicit Opioids	Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids.	From Baseline to Week4
Other	Treatment Retention	Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method	From Baseline to Week 4
Other	Device Wearing Time	Device wearing time as measured by EmbracePlus wearable device data	From Baseline to Week 4
Other	Physiological Biomarker Data	Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device	From Baseline to Week 4
Primary	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
Primary	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
Primary	Buprenorphine Initiation Success	Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit	Week 1
Primary	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	PEAR-002B Engagement Data	PEAR-002B engagement rates as measured by participant use patterns data	From Baseline to Week 1
Secondary	reSET-O Qualitative User Experience Interviews	Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes	Week 4
Secondary	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	Week 4