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NCT07281261 · ClinicalTrials.gov registry record · NA
tAN for Substance Use Disorder
A NA study, sponsored by Spark Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT07281261: Recruiting NA study, sponsored by Spark Biomedical.
NCT07281261 is a NA study that is actively recruiting participants, run by Spark Biomedical. The registered enrollment target is 20 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
NCT07281261, a NA study, is actively recruiting participants, sponsored by Spark Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
Primary Outcome
The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal.
Interventions
- DEVICE Sparrow Ascent
- DEVICE Sparrow Ascent (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-01-28 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT07281261 shows while recruiting
NCT07281261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 Sparrow Ascent is the first listed.
NCT07281261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07281261 about?
NCT07281261 is a clinical study titled "tAN for Substance Use Disorder". The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) fo...
What is the current status of trial NCT07281261?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-01-28. Estimated completion is 2026-08-31.
What interventions are being tested in trial NCT07281261?
The interventions under investigation include: Sparrow Ascent (DEVICE), Sparrow Ascent (Sham) (DEVICE).
Who is sponsoring clinical trial NCT07281261?
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 NCT07281261's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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