Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings

This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Device: reSET-O app

Detailed Description

This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: August Holtyn; Phone Number: 4105509691; Email: aholtyn1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayivew Emergency Department
      • Contact: August Holtyn; Phone Number: 410-550-9691; Email: aholtyn1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years old
• Opioid use disorder
• Eligible for buprenorphine treatment
• Has reSET-O compatible mobile device

Exclusion Criteria:

• Pregnancy
• Significant psychiatric comorbidity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: reSET-O + Treatment-As-Usual (TAU); Participants randomly assigned to this group will receive the TAU plus the reSET-O app.	Device: reSET-O app; The reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse.
No Intervention: Treatment-As-Usual (TAU); Participants randomly assigned to this group will receive the TAU only (no use of the reSET-O app).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of approached patients who are eligible for and interested in participation	Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.	3 months
Acceptability as assessed by the Treatment Acceptability Questionnaire	Participant responses to the Treatment Acceptability Questionnaire.	3 months
Acceptability as assessed by the System Usability Scale	Participant responses to the System Usability Scale.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge	Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.	30 days
Percentage of drug-negative urine samples during the 3-month intervention	Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Pear Therapeutics, Inc.
• Investigators: Principal Investigator: August Holtyn, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB00282938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No