N/A
Completed N=100
reSET-O RCT (Randomized Controlled Trial)
Source: ClinicalTrials.gov NCT04129580 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
May 2024
Primary outcomePrimary: Retention in Treatment on MAT for 6 Months After Enrolling in the Study — 34; 27 Participants
Summary
This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention in Treatment on MAT for 6 Months After Enrolling in the Study |
34; 27 | — |
| SECONDARY Opioid and Other Substance Abuse as Assessed Through Biological Specimen |
32; 33 | — |
| SECONDARY Opioid and Other Substance Abuse as Assessed Through Participant Self-report |
23; 17 | — |
| SECONDARY Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10 |
-4.23; -4.66 | — |
| SECONDARY Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9 |
-2.93; -1.65 | — |
| SECONDARY Mental Health Symptoms Related to PTSD as Assessed by the PCL-C |
-4.71; -6.60 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
- Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
- Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
- Prison inmates are eligible to participate in the study
- Ability to read, write, and comprehend English
Exclusion Criteria
- Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
- Planning an outpatient detoxification
- Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
- Less than 18 years of age
- Unable to read, write, and comprehend English
Data sourced from ClinicalTrials.gov (NCT04129580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.