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

May 21, 2024 updated by: Johns Hopkins University
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

Terminated

Conditions

Intervention / Treatment

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 (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayivew Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months
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
Time Frame: 3 months
Participant responses to the Treatment Acceptability Questionnaire.
3 months
Acceptability as assessed by the System Usability Scale
Time Frame: 3 months
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
Time Frame: 30 days
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
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Pear Therapeutics, Inc.

Investigators

  • Principal Investigator: August Holtyn, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

May 1, 2024

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)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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