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A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic

NCT04542642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-12-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.

Conditions

  • Opioid-use Disorder

Interventions

DEVICE

reSET-O

reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.

DEVICE

PEAR-008

PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.

Sponsors & Collaborators

  • Addiction Research and Education Foundation (AREF)

    collaborator UNKNOWN

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Pear Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Aimee Campbell, PhD · Columbia University

  • Lisa Chiodo, PhD · Addiction Research and Education Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2022-11-16
Completion
2022-11-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542642 on ClinicalTrials.gov