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Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
NCT05160233 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Health Coaching
- BEHAVIORAL Practice Facilitation
- BEHAVIORAL Standard implementation
Study Locations (1)
Washington
- Kaiser Permanente Washington — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,000 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2024-09-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05160233
The ClinicalTrials.gov registry entry for NCT05160233 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions — of which Health Coaching is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05160233 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05160233 about?
NCT05160233 is a clinical study titled "Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care". 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 Was...
What is the current status of trial NCT05160233?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 13,000 participants. The study started on 2021-12-09. Estimated completion is 2024-09-09.
What conditions does trial NCT05160233 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Alcohol-Related Disorders, Drug Use Disorders, Illicit Drug Use. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05160233?
The interventions under investigation include: Health Coaching (BEHAVIORAL), Practice Facilitation (BEHAVIORAL), Standard implementation (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05160233?
This trial is sponsored by Kaiser Permanente, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05160233 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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