N/A
Completed N=18,430
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
Drug use disorders · Illicit Drug Use · Alcohol-Related Disorders · Opioid Use Disorder
Source: ClinicalTrials.gov NCT05160233 ↗
Enrolled (actual)
18,430
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Reach of the Digital Therapeutic to Patients in the Primary Care Clinic — 7.39; 0.73; 22.66; 15.65 Patients reached per 10000 patients — p=0.043
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. The DIGITS Trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Kaiser Permanente Washington, a healthcare delivery system in Washington State.
In this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reach of the Digital Therapeutic to Patients in the Primary Care Clinic |
7.39; 0.73; 22.66; 15.65 | 0.043 sig |
| PRIMARY Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations |
7.39; 0.73; 22.66; 102.26 | 0.288 |
| SECONDARY Engagement |
17.68; 0.00; 59.55; 40.86 | 0.091 |
| SECONDARY Economic Costs |
19390; 36068; 29791; 46652 | — |
Eligibility Criteria
Patient Inclusion Criteria:
- Had a primary care visit in a participating clinic during the active implementation period or sustainment period
- Screened positive for substance use on the day of the visit or in the prior year
- Adult aged 18 years or older at time of visit
Clinic Inclusion Criteria:
- At least 1 clinician trained in the use of reSET/reSET-O
Patient Exclusion Criteria:
- Patients who have requested through their health system to opt out of research
Clinic Exclusion Criteria:
- Previously participated in a pilot implementation of reSET/reSET-O
Data sourced from ClinicalTrials.gov (NCT05160233). 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.