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NCT04162145 · ClinicalTrials.gov registry record · NA
BRIDGE Device for Treatment of Opioid Withdrawal
A NA study, sponsored by BrightView.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04162145: Clinical Trial NA study, sponsored by BrightView.
NCT04162145 is a NA study that was terminated before completion, run by BrightView. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04162145, a NA study, was terminated before completion, sponsored by BrightView.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.
Primary Outcome
The primary outcome is comparison of change from baseline of the Clinical Opiate Withdrawal Scale (COWS) scores( score: 5-12=Mild; 13-24=Moderate; 25-36=Moderately Severe; More than 36=Severe Withdrawal) between active BRIDGE device group and sham BRIDGE device group at one hour. The two groups will be compared using a two-sided two sample t-test at an alpha of 0.001 at an interim analysis of the first 24 completing and at an alpha of 0.049 after 50 have completed. For all the efficacy paramete
Interventions
- DEVICE Active BRIDGE device placement
- DEVICE Inactive BRIDGE device placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2020-06-23 |
| Phase | NA |
Why NCT04162145 stopped before completion
NCT04162145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Active BRIDGE device placement is the first listed.
NCT04162145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04162145 about?
NCT04162145 is a clinical study titled "BRIDGE Device for Treatment of Opioid Withdrawal". The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.
What is the current status of trial NCT04162145?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2019-11-15. Estimated completion is 2020-06-23.
What interventions are being tested in trial NCT04162145?
The interventions under investigation include: Active BRIDGE device placement (DEVICE), Inactive BRIDGE device placement (DEVICE).
Who is sponsoring clinical trial NCT04162145?
This trial is sponsored by BrightView, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04162145's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 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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