reSET-O RCT (Randomized Controlled Trial)

NCT ID: NCT04129580

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2024-09-19

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 after initiating medication assisted treatment.

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 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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

reSET-O app

Intervention Type: DEVICE

The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse,

TAU only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

reSET-O app

The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse,

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Pear Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Kawasaki

Associate Professor of Pennsylvania Psychiatric Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00012685

Identifier Type: -

Identifier Source: org_study_id