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NCT04218201 · ClinicalTrials.gov registry record · NA
Subthreshold Opioid Use Disorder Prevention (STOP) Trial
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 321
- Enrollment target
NCT04218201: Completed NA study, sponsored by NYU Langone Health.
NCT04218201 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 321 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04218201, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 321 participants
- Enrollment target
Study Summary
The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-randomized trial, conducted in 5 primary care sites, with 100 PCPs and 300adult primary care patients, will test the efficacy of STOP versus enhanced usual care (EUC). The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the current opioid crisis.
Primary Outcome
Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 6 months after the baseline visit using single items from the Addiction Severity Index. Illicit opioid use includes use of heroin or synthetic opioids. Nonmedical opioid use includes using prescribed opioids more frequently or at higher doses than instructed on the prescription (e.g., taking 2 tablets when the prescription indicates a dose of 1 tablet), or taking pharmaceutical opioids that
Interventions
- BEHAVIORAL PCP brief advice
- BEHAVIORAL Video doctor
- BEHAVIORAL Telephone health coaching
- BEHAVIORAL Nurse Care Manager (NCM) intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2020-03-25 |
| Est. Completion | 2024-05-17 |
| Phase | NA |
What the finished NCT04218201 record still lists
NCT04218201 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which PCP brief advice is the first listed.
NCT04218201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04218201 about?
NCT04218201 is a clinical study titled "Subthreshold Opioid Use Disorder Prevention (STOP) Trial". The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-rand...
What is the current status of trial NCT04218201?
This trial is currently completed. It is a NA study. The enrollment target is 321 participants. The study started on 2020-03-25. Estimated completion is 2024-05-17.
What interventions are being tested in trial NCT04218201?
The interventions under investigation include: PCP brief advice (BEHAVIORAL), Video doctor (BEHAVIORAL), Telephone health coaching (BEHAVIORAL), Nurse Care Manager (NCM) intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04218201?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04218201's enrollment target sits among peer trials
321 315th of 2000 higher than 1,686 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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