NCT05412966

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

A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pear Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	PEAR-002B	PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
DEVICE	reSET-O	reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.

Timeline

• Start date: 2022-11-04
• Primary completion: 2022-11-23
• Completion: 2022-12-16
• First posted: 2022-06-09
• Last updated: 2023-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study