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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817267
Recruitment Status : Not yet recruiting
First Posted : March 26, 2021
Last Update Posted : February 9, 2022
Sponsor:
Collaborator:
Pear Therapeutics, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Device: reSET-O app Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024
Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Acceptability as assessed by the Treatment Acceptability Questionnaire [ Time Frame: 3 months ]
    Participant responses to the Treatment Acceptability Questionnaire.

  3. Acceptability as assessed by the System Usability Scale [ Time Frame: 3 months ]
    Participant responses to the System Usability Scale.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817267


Contacts
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Contact: August Holtyn 4105509691 aholtyn1@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Pear Therapeutics, Inc.
Investigators
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Principal Investigator: August Holtyn Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04817267    
Other Study ID Numbers: IRB00282938
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders