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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
Must not have
Less than 18 years of age
Planning an outpatient detoxification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am planning to undergo detoxification as an outpatient.
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I am starting or switching to a maintenance treatment that does not involve medication-assisted therapy.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Retention in Treatment on MAT for 6 Months After Enrolling in the Study
Secondary study objectives
Mental Health Symptoms Related to PTSD as Assessed by the PCL-C
Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9
Opioid and Other Substance Abuse as Assessed Through Biological Specimen
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Pear Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
1,757 Total Patients Enrolled
Columbia UniversityOTHER
1,486 Previous Clinical Trials
2,655,231 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,532 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
~20 spots leftby Nov 2025
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