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NCT05053503 · ClinicalTrials.gov registry record · NA
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
A NA study, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT05053503: Completed NA study, sponsored by Spark Biomedical.
NCT05053503 is a NA study that has completed, run by Spark Biomedical. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05053503, a NA study, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
Primary Outcome
In Phase II, participants will provide a weekly urine sample to determine if opioids have been used in the past week (in conjunction with a self-report). A urine drug screen cup will be used to detect presence of: Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), and Tramadol. The urine drug screen cup also contains a temperature strip to confirm ap
Interventions
- DRUG Lofexidine
- DEVICE Sparrow Ascent Therapy System
- DRUG Extended-release injectable naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2025-04-04 |
| Phase | NA |
What the finished NCT05053503 record still lists
NCT05053503 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Lofexidine is the first listed.
NCT05053503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05053503 about?
NCT05053503 is a clinical study titled "Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder". The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
What is the current status of trial NCT05053503?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2022-05-27. Estimated completion is 2025-04-04.
What interventions are being tested in trial NCT05053503?
The interventions under investigation include: Lofexidine (DRUG), Sparrow Ascent Therapy System (DEVICE), Extended-release injectable naltrexone (DRUG).
Who is sponsoring clinical trial NCT05053503?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05053503's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 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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