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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 belowSelect...
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
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
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 moreTrial 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).
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Who is running the clinical trial?
Pear Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
1,757 Total Patients Enrolled
Columbia UniversityOTHER
1,439 Previous Clinical Trials
2,447,644 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,346 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I recently started outpatient treatment for opioid use disorder at Penn State Health.I am starting treatment for opioid use disorder with specific medications.I am under 18 years old.I am planning to undergo detoxification as an outpatient.I am starting or switching to a maintenance treatment that does not involve medication-assisted therapy.I am 18 years old or older.You have been diagnosed with opioid addiction by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment-As-Usual (TAU) + reSET-O
- Group 2: TAU only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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