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NCT05160233 · ClinicalTrials.gov registry record · NA
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
A NA study of Opioid Use Disorder and Alcohol-Related Disorders, sponsored by Kaiser Permanente.
- Active
- Registry status
- NA
- Development phase
- 13,000
- Enrollment target
- 1
- Study location
NCT05160233: Active NA study of Opioid Use Disorder and Alcohol-Related Disorders, sponsored by Kaiser Permanente.
NCT05160233 is a NA study of Opioid Use Disorder and Alcohol-Related Disorders that is active but no longer recruiting, run by Kaiser Permanente. The registered enrollment target is 13,000 participants, above the 4,606-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (182% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05160233, a NA study of Opioid Use Disorder and Alcohol-Related Disorders, is active but no longer recruiting, sponsored by Kaiser Permanente.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 13,000 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
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 |
What the registry record for NCT05160233 still lists
NCT05160233 is an interventional study that assigns participants to a tested intervention. Its 13,000 participants enrollment target places it among the larger protocols in the corpus, above the 4,606-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (182% higher).
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.
NCT05160233 reports a single indexed study location in Washington.
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.
What interventions are being tested in trial NCT05160233?
The interventions under investigation include: Health Coaching (BEHAVIORAL), Practice Facilitation (BEHAVIORAL), Standard implementation (BEHAVIORAL).
Who is sponsoring clinical trial NCT05160233?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05160233's enrollment target sits among peer trials
13,000 6th of 257 higher than 252 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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