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reSET-O App for Opioid Use Disorder

N/A

Waitlist Available

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will be testing an app to help people with opioid use disorder stay in treatment.

Who is the study for?

This trial is for adults over 18 with opioid use disorder (OUD) who recently started outpatient treatment within the Penn State Health system. They must be starting or on medication-assisted treatment (MAT) with buprenorphine-naloxone, buprenorphine, or methadone. Pregnant women and prison inmates meeting these criteria can also join. Those planning detoxification, needing inpatient care, under 18, or unable to understand English are excluded.Check my eligibility

What is being tested?

The study tests the reSET-O app by Pear Therapeutics to see if it helps people stay in treatment after they start MAT for OUD. Participants will randomly receive either standard care or standard care plus the app to compare retention rates between groups.See study design

What are the potential side effects?

Since this trial involves an app rather than a drug, traditional side effects aren't expected. However, participants may experience discomfort from increased engagement with their treatment process due to regular app usage.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Retention in treatment on MAT for 6 months after enrolling in the study

Secondary outcome measures

Coping strategies as assessed by the CSS

Cravings to use drugs as assessed by the reSET-O app

Effectiveness of the reSET app content as measured by the IAFF

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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

Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O.

Group II: TAU onlyActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pear Therapeutics, Inc.Industry Sponsor

5 Previous Clinical Trials

1,809 Total Patients Enrolled

Columbia UniversityOTHER

1,431 Previous Clinical Trials

2,460,723 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,480 Total Patients Enrolled

Media Library

reSET-O app Clinical Trial Eligibility Overview. Trial Name: NCT04129580 — N/A

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

Opioid Use Disorder Clinical Trial 2023: reSET-O app Highlights & Side Effects. Trial Name: NCT04129580 — N/A

reSET-O app 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129580 — N/A

Frequently Asked Questions

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

Are minors able to partake in the medical experiment?

"This medical trial is looking for participants aged 18 and above, but younger than a century."

Answered by AI

How many participants has this research endeavor enrolled thus far?

"Affirmative. Clinicaltrials.gov documents demonstrate that this investigation, which launched on the 15th of September 2020, is still searching for participants to enroll in their trial. 200 volunteers will be recruited from a single site."

Answered by AI

Are recruitment efforts underway for this investigation?

"Yes, according to the details posted on clinicaltrials.gov, this research is actively in search of 200 individuals from a single location. The trial was initially advertised on September 15th 2020 and its information updated most recently on May 23rd 2022."

Answered by AI

May I be included in this clinical experiment?

"Penn State Health is looking to recruit 200 volunteers, aged 18-100, who suffer from opioid use disorder (OUD) and are undergoing outpatient treatment. Participants must be taking the FDA approved medication buprenorphine (Subutex), buprenorphine-naloxone (suboxone), or methadone for MAT therapy in order to qualify. Notably, pregnant women and prison inmates can take part provided they meet all other criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

reSET-O RCT (Randomized Controlled Trial)

Sarah Kawasaki 2020. "reSET-O RCT (Randomized Controlled Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04129580.

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