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NCT04075214 · ClinicalTrials.gov registry record · NA
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
A NA study of Opioid Use Disorder and Opioid Withdrawal, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04075214: Completed NA study of Opioid Use Disorder and Opioid Withdrawal, sponsored by Spark Biomedical.
NCT04075214 is a NA study of Opioid Use Disorder and Opioid Withdrawal that has completed, run by Spark Biomedical. The registered enrollment target is 35 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075214, a NA study of Opioid Use Disorder and Opioid Withdrawal, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
Primary Outcome
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of active tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indic
Conditions Studied
Interventions
- DEVICE transcutaneous auricular neurostimulation (tAN)
Study Locations (1)
Texas
- Recovery Unplugged - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2020-12-14 |
| Phase | NA |
What the finished NCT04075214 record still lists
NCT04075214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which transcutaneous auricular neurostimulation (tAN) is the first listed.
NCT04075214 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04075214 about?
NCT04075214 is a clinical study titled "Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal". Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
What is the current status of trial NCT04075214?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2019-11-19. Estimated completion is 2020-12-14.
What conditions does trial NCT04075214 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Withdrawal.
What interventions are being tested in trial NCT04075214?
The interventions under investigation include: transcutaneous auricular neurostimulation (tAN) (DEVICE).
Who is sponsoring clinical trial NCT04075214?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04075214 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04075214's enrollment target sits among peer trials
35 196th of 257 higher than 60 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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