A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic
NCT ID: NCT04542642
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2021-05-19
2022-11-23
Brief Summary
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Detailed Description
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PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment (available by prescription only) for opioid use disorder. The study will examine if changing the application's delivery format and enhancing clinical content affects how patients use and interact with the intervention.
Prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the Baseline visit. Qualifying participants will attend weekly virtual study visits during the 8-week treatment period.
In addition to weekly assessments, additional assessments will be administered at week 4 and week 8. Participants will be asked to complete a follow-up assessment 4 weeks after completing treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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reSET-O
Prescription Digital therapeutic
reSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
PEAR-008
Investigational Digital Therapeutic
PEAR-008
PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.
Interventions
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reSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
PEAR-008
PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 60 years old, inclusively
* Proficient in English language
* Within the first 120 days of starting buprenorphine treatment
* Receiving buprenorphine pharmacotherapy under the care of a licensed healthcare provider and willing to provide the provider or practice name
* Capable of using common software applications on a mobile device (smartphone)
* Access to an internet-enabled smartphone for the duration of the study, meeting minimal operations systems (OS) requirements
* Interest in using a digital therapeutic for Opioid-use Disorder
* No prior history of reSET-O use
* Has not participated in user testing of PEAR-008 or any investigational drug trials within the past 30 days of enrollment
Exclusion Criteria
* Unable to use English to participate in the consent process, interventions, or assessments
* Inability to comply with study procedures
18 Years
60 Years
ALL
No
Sponsors
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Addiction Research and Education Foundation (AREF)
UNKNOWN
Research Foundation for Mental Hygiene, Inc.
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Pear Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aimee Campbell, PhD
Role: STUDY_DIRECTOR
Columbia University
Lisa Chiodo, PhD
Role: STUDY_DIRECTOR
Addiction Research and Education Foundation
Locations
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The Substance and Treatment Research Service (STARS) at Columbia University Irving Medical Center and the New York State Psychiatric Institute
New York, New York, United States
Addiction Research and Education Foundation
Gig Harbor, Washington, United States
Countries
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References
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Luderer H, Chiodo L, Wilson A, Brezing C, Martinez S, Xiong X, Gerwien R, Imbert B, Deeg M, Maricich Y, Campbell A. Patient Engagement With a Game-Based Digital Therapeutic for the Treatment of Opioid Use Disorder: Protocol for a Randomized Controlled Open-Label, Decentralized Trial. JMIR Res Protoc. 2022 Jan 26;11(1):e32759. doi: 10.2196/32759.
Other Identifiers
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PEAR-008-101
Identifier Type: -
Identifier Source: org_study_id