reSET-O app for Opioid Abuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Opioid Abuse+1 More
reSET-O app - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test an app to help people starting buprenorphine in hospitals. The app will track patients' progress and help them stay on track with their treatment.

Eligible Conditions
  • Opioid Abuse
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 3 months

3 months
Acceptability as assessed by the System Usability Scale
Acceptability as assessed by the Treatment Acceptability Questionnaire
Percentage of approached patients who are eligible for and interested in participation
Percentage of drug-negative urine samples during the 3-month intervention
30 days
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment-As-Usual (TAU)
1 of 2
reSET-O + Treatment-As-Usual (TAU)
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: reSET-O app · No Placebo Group · N/A

reSET-O + Treatment-As-Usual (TAU)
Device
Experimental Group · 1 Intervention: reSET-O app · Intervention Types: Device
Treatment-As-Usual (TAU)NoIntervention Group · 1 Intervention: Treatment-As-Usual (TAU) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,055 Previous Clinical Trials
30,974,921 Total Patients Enrolled
1 Trials studying Opioid Abuse
12 Patients Enrolled for Opioid Abuse
Pear Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
1,952 Total Patients Enrolled
August HoltynPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
375 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.