Status:
COMPLETED
reSET-O RCT (Randomized Controlled Trial)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Columbia University
Pear Therapeutics, Inc.
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder afte...
Detailed Description
This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
- Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
- Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
- Prison inmates are eligible to participate in the study
- Ability to read, write, and comprehend English
Exclusion
- Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
- Planning an outpatient detoxification
- Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
- Less than 18 years of age
- Unable to read, write, and comprehend English
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04129580
Start Date
September 15 2020
End Date
September 19 2024
Last Update
November 20 2024
Active Locations (1)
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1
Pennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, United States, 17110