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reSET-O App for Opioid Use Disorder

N/A

Recruiting

Led By August Holtyn

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for buprenorphine treatment

18-65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder who are starting buprenorphine treatment and own a mobile device compatible with the reSET-O app. It's not for pregnant individuals or those with significant psychiatric conditions.Check my eligibility

What is being tested?

The study tests the reSET-O app as an addition to usual care in acute settings for patients on buprenorphine. It's a pilot study, meaning it's preliminary research to see if the app is feasible, acceptable, and potentially effective.See study design

What are the potential side effects?

Since this trial involves using an app rather than medication, traditional side effects aren't expected. However, users may experience stress or frustration if they encounter technical issues or find the interface challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for buprenorphine treatment.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge

Percentage of drug-negative urine samples during the 3-month intervention

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: reSET-O + Treatment-As-Usual (TAU)Experimental Treatment1 Intervention

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

Group II: Treatment-As-Usual (TAU)Active Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,257 Previous Clinical Trials

14,820,071 Total Patients Enrolled

Pear Therapeutics, Inc.Industry Sponsor

5 Previous Clinical Trials

1,857 Total Patients Enrolled

August HoltynPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

375 Total Patients Enrolled

Media Library

reSET-O app Clinical Trial Eligibility Overview. Trial Name: NCT04817267 — N/A

Opioid Use Disorder Research Study Groups: reSET-O + Treatment-As-Usual (TAU), Treatment-As-Usual (TAU)

Opioid Use Disorder Clinical Trial 2023: reSET-O app Highlights & Side Effects. Trial Name: NCT04817267 — N/A

reSET-O app 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being recruited for this clinical experiment?

"Absolutely. Clinicaltrials.gov data shows that this medical experiment, which was launched on March 11th 2022, is currently recruiting participants. Approximately 60 individuals need to be included from 1 trial site."

Answered by AI

Does this research project admit participants younger than two decades of age?

"The requirements for this trial dictate that all participants must have an age between 18 to 65 years old. However, there are separate trials catering to those under 18 and above the benchmark of 65 years old - 22 studies and 241 respectively."

Answered by AI

How many individuals have joined this research project?

"Affirmative. The data held on clinicaltrials.gov reveals that since March 11th 2022, this research project has been looking for 60 individuals to take part at one centre. This listing was last updated on March 16th 2022."

Answered by AI

Does my profile meet the requirements to join this experiment?

"To qualify for this clinical trial, potential participants must demonstrate opioid abuse and fall within the age bracket of 18 to 65. 60 people are being recruited in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817267.