reSET-O RCT (Randomized Controlled Trial)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    200
  • sponsor
    Milton S. Hershey Medical Center
Updated on 8 June 2022

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 after initiating medication assisted treatment.

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 TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.

Details
Condition Opioid-use Disorder
Treatment reSET-O app
Clinical Study IdentifierNCT04129580
SponsorMilton S. Hershey Medical Center
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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