Study Stopped
ReSET-O product no longer available, Pear Therapeutics, Inc. filed for bankruptsy
Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMay 23, 2024
May 1, 2024
10 months
March 23, 2021
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
30 days
Percentage of drug-negative urine samples during the 3-month intervention
3 months
Study Arms (2)
reSET-O + Treatment-As-Usual (TAU)
EXPERIMENTALParticipants randomly assigned to this group will receive the TAU plus the reSET-O app.
Treatment-As-Usual (TAU)
NO INTERVENTIONParticipants randomly assigned to this group will receive the TAU only (no use of the reSET-O app).
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old
- Opioid use disorder
- Eligible for buprenorphine treatment
- Has reSET-O compatible mobile device
You may not qualify if:
- Pregnancy
- Significant psychiatric comorbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Pear Therapeutics, Inc.collaborator
Study Sites (1)
Johns Hopkins Bayivew Emergency Department
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
August Holtyn
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2021
First Posted
March 26, 2021
Study Start
March 11, 2022
Primary Completion
January 1, 2023
Study Completion
May 1, 2024
Last Updated
May 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share