reSET-O RCT (Randomized Controlled Trial)

NCT04129580 | Completed Results DMC FDA Device

• 1 other identifier: 00012685
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Retention in Treatment on MAT for 6 Months After Enrolling in the Study

  reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.

  6 months

Secondary Outcomes (5)

• Opioid and Other Substance Abuse as Assessed Through Biological Specimen

  6 months

• Opioid and Other Substance Abuse as Assessed Through Participant Self-report

  6 months

• Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10

  6 months

• Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9

  6 months

• Mental Health Symptoms Related to PTSD as Assessed by the PCL-C

  6 months

Study Arms (2)

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

EXPERIMENTAL

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

Device: reSET-O app

TAU only

NO INTERVENTION

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

Interventions

reSET-O app 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,

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Columbia University: collaborator
• Pear Therapeutics, Inc.: collaborator
• National Institutes of Health (NIH): collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (1)

Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, 17110, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Sarah Kawasaki
• Organization: Penn State Milton S. Hershey Medical Center

skawasaki@pennstatehealth.psu.edu

7175311000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pennsylvania Psychiatric Institute

Model Details: Single site, randomized controlled trial research study.

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: September 15, 2020
• Primary Completion: July 14, 2023
• Study Completion: September 19, 2024
• Last Updated: November 20, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)