N/A
Completed N=1,552
An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
Drug use disorders · Illicit Drug Use · Alcohol-Related Disorders
Source: ClinicalTrials.gov NCT04907045 ↗
Enrolled (actual)
1,552
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Reach of the Digital Therapeutic to Patients in the Primary Care Clinic — 1; 4 Participants
Summary
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reach of the Digital Therapeutic to Patients in the Primary Care Clinic |
1; 4 | — |
| PRIMARY Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations |
0; 0 | — |
| SECONDARY Effectiveness |
0.01; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Had a primary care visit in a participating clinic during the pilot
- Screened positive for substance use
- Adult aged 18 years or older at time of visit
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04907045). 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.