reSET-O RCT (Randomized Controlled Trial)

Milton S. Hershey Medical Center100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Opioid-use Disorder

Interventions

reSET-O appDEVICE

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,

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Opioid and Other Substance Abuse as Assessed Through Biological Specimen

Part of this study is looking at the effect of reSET-O on substance use. This will be measured by collecting urine drug screens to assess drug use (if any) at each research appointment. The number of endorsed drugs used (as indicated by a positive urine drug screen) will be counted and recorded for each research visit.

Time frame: 6 months

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

Part of this study is looking at the effect of reSET-o on substance use. This will be measured by participant self-report on the Timeline Follow Back Questionnaire (TLFB). The TLFB is a self-report measure that gages the participant's memory by using a calendar to assess drug use within a specific period of time. The number of endorsed drugs used (as indicated by the participant) will be counted and recorded for each research visit.

Time frame: 6 months

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

Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as overall mental health symptoms as measured by participant self-report on the Kessler 10 (K-10). A score of one indicates that an individual experiences symptoms or issues "None of the time," whereas a score of five indicates that an individual experiences symptoms or issues "All of time." The scores are summed and total amounts will fall in one of four categories: Score under 20 = likely to be well; Score 20-24 = likely to have a mild mental disorder; Score 25-29 = likely to have a moderate mental disorder; and Score 30 or more = likely to have a severe mental disorder. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.

Data from ClinicalTrials.gov

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