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

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reSET-O app
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayivew Emergency DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Treatment-As-Usual (TAU)

Arm Description

Participants randomly assigned to this group will receive the TAU plus the reSET-O app.

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

Outcomes

Primary Outcome Measures

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.
Acceptability as assessed by the Treatment Acceptability Questionnaire
Participant responses to the Treatment Acceptability Questionnaire.
Acceptability as assessed by the System Usability Scale
Participant responses to the System Usability Scale.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 23, 2021
Last Updated
March 22, 2023
Sponsor
Johns Hopkins University
Collaborators
Pear Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04817267
Brief Title
Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Official Title
Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Pear Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
reSET-O + Treatment-As-Usual (TAU)
Arm Type
Experimental
Arm Description
Participants randomly assigned to this group will receive the TAU plus the reSET-O app.
Arm Title
Treatment-As-Usual (TAU)
Arm Type
No Intervention
Arm Description
Participants randomly assigned to this group will receive the TAU only (no use of the reSET-O app).
Intervention Type
Device
Intervention Name(s)
reSET-O app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of approached patients who are eligible for and interested in participation
Description
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Time Frame
3 months
Title
Acceptability as assessed by the Treatment Acceptability Questionnaire
Description
Participant responses to the Treatment Acceptability Questionnaire.
Time Frame
3 months
Title
Acceptability as assessed by the System Usability Scale
Description
Participant responses to the System Usability Scale.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
Description
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.
Time Frame
30 days
Title
Percentage of drug-negative urine samples during the 3-month intervention
Description
Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
August Holtyn
Phone
4105509691
Email
aholtyn1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
August Holtyn
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayivew Emergency Department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
August Holtyn
Phone
410-550-9691
Email
aholtyn1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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