NCT05160233: DIGITS

Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care

Completed NA Results posted Last updated 8 April 2026

What this trial tests

NA trial testing Standard implementation in Drug Use Disorders in 18,430 participants. Completed in 27 January 2025.

Timeline

9 December 2021

Primary endpoint
22 August 2024

27 January 2025

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	health services research
Enrollment	18,430
Start date	9 December 2021
Primary completion	22 August 2024
Estimated completion	27 January 2025
Sites	1 location across United States

Drugs / interventions tested

• Standard implementation
• Health Coaching
• Practice Facilitation

Conditions studied

• Drug Use Disorders — all drugs for Drug Use Disorders →
• Illicit Drug Use — all drugs for Illicit Drug Use →
• Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →
• Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Drug Use Disorders or Illicit Drug Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reach of the Digital Therapeutic to Patients in the Primary Care Clinic Primary · 12 months

Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.

Group	Value	95% CI
Standard Implementation	7.39	± 10.48
Standard Implementation Plus Health Coaching	0.73	± 1.63
Standard Implementation Plus Practice Facilitation	22.66	± 21.49
Standard Implementation Plus Health Coaching and Practice Facilitation	15.65	± 13.13

Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations Primary · 15 months

Mean number of weeks during patients' 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 1

Group	Value	95% CI
Standard Implementation	7.39	± 10.48
Standard Implementation Plus Health Coaching	0.73	± 1.63
Standard Implementation Plus Practice Facilitation	22.66	± 21.49
Standard Implementation Plus Health Coaching and Practice Facilitation	102.26	± 111.16

Engagement Secondary · 15 months

Mean number of months in which patients make ≥1 visit for substance use disorder. This measure is reported as the number of patient month per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a month was one with engagement, we identify each patient's reSET activation date and examine for module use during the following 3 months. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 3 months to examine engagement for patients who are reached on th

Group	Value	95% CI
Standard Implementation	17.68	± 24.22
Standard Implementation Plus Health Coaching	0.00	± 0.00
Standard Implementation Plus Practice Facilitation	59.55	± 57.23
Standard Implementation Plus Health Coaching and Practice Facilitation	40.86	± 38.91

Economic Costs Secondary · 37 months

Costs from the perspective of a health system and payer including implementation, direct intervention, operating, and other indirect health care costs. This measure will be used to calculate the population-level cost effectiveness of increasing reach, fidelity, and engagement. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period.

Group	Value	95% CI
Standard Implementation	19390
Standard Implementation Plus Health Coaching	36068
Standard Implementation Plus Practice Facilitation	29791
Standard Implementation Plus Health Coaching and Practice Facilitation	46652

Reach-2 Secondary · 12 months

Patients prescribed reSET or reSET-O. The measure is reported as the number of patients prescribed per 10,000 patients, calculated at a clinic level.

Group	Value	95% CI
Standard Implementation	14.32	± 13.49
Standard Implementation Plus Health Coaching	9.88	± 10.07
Standard Implementation Plus Practice Facilitation	37.66	± 18.75
Standard Implementation Plus Health Coaching and Practice Facilitation	37.43	± 12.76

Fidelity-2 Secondary · 15 months

Mean number of weeks in which patients use at least 1 module/week. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active

Group	Value	95% CI
Standard Implementation	19.03	± 31.57
Standard Implementation Plus Health Coaching	0.73	± 1.63
Standard Implementation Plus Practice Facilitation	36.81	± 40.76
Standard Implementation Plus Health Coaching and Practice Facilitation	102.26	± 111.16

Substance Use Secondary · Up to 18 months from the patients index visit date

Patients who are reached and reduce their substance use

Group	Value	95% CI
Standard Implementation	0
Standard Implementation Plus Health Coaching	1
Standard Implementation Plus Practice Facilitation	8
Standard Implementation Plus Health Coaching and Practice Facilitation	7

Abstinence Secondary · Up to 18 months from the patients index visit date

Patients who are reached and are abstinent from substances. This is reported as the number of patients who are reached and achieve abstinence.

Group	Value	95% CI
Standard Implementation	0
Standard Implementation Plus Health Coaching	1
Standard Implementation Plus Practice Facilitation	2
Standard Implementation Plus Health Coaching and Practice Facilitation	5

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).
   Glass JE, Dorsey CN, Beatty T, Bobb JF, et al · · 2023 · cited 14× · PMID 36726127 · DOI 10.1186/s13012-022-01258-9
2. Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study.
   Mogk J, Idu AE, Bobb JF, Key D, et al · · 2024 · cited 6× · PMID 39222348 · DOI 10.2196/59088
3. Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study.
   Xie CX, Toader AM, De Simoni A, Eldridge S, et al · · 2026 · PMID 41965800 · DOI 10.1186/s13063-026-09706-3
4. Economic cost of strategic implementation approaches to increase uptake of digital therapeutics for substance use disorders in a large integrated health system.
   Wong ES, Dorsey CN, Beatty TC, Bobb JF, et al · · 2026 · PMID 41505485 · DOI 10.1371/journal.pdig.0001145