Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT05412966
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
Sponsor:
Pear Therapeutics, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44DA049493 | NIH | None | https://reporter.nih.gov/quic… | View |