reSET-O RCT (Randomized Controlled Trial)

Penn State Health

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Device: reSET-O app

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04129580

00012685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment-As-Usual (TAU) + reSET-O

Experimental group

Description:

Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O.

Treatment:

Device: reSET-O app

TAU only

No Intervention group

Description:

Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).