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Recruiting NCT07281261

tAN for Substance Use Disorder

No phase Interventional Alcohol Use Disorder Alcohol Abuse Substance Use Disorders Substance Use Disorders Alcohol Use Withdrawal State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sparrow Ascent, Sparrow Ascent (Sham).
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder

Overview

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.

Interventions

  • Device Sparrow Ascent
    The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece.
  • Device Sparrow Ascent (Sham)
    Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.

Primary outcome measures

  • Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) [Time frame: Every 4 hours during the tAN treatment (Days 2-6)]
  • Average benzodiazepine use [Time frame: Every 4 hours during the tAN treatment (Days 2-6)]
Secondary outcome measures (3)
  • Penn Alcohol Craving Scale (PACS) [Time frame: Before Day 2 and after tAN treatment on Day 6]
  • Montgomery-Asberg Depression Scale (MADRS) [Time frame: Before Day 2 and after tAN treatment on Day 6]
  • Suicidal Behaviors Questionnaire-Revised (SBQ-R) [Time frame: Before Day 2 and after tAN treatment on Day 6]

Eligibility criteria

Inclusion criteria

  • Male or female (evenly recruited) aged 18-64 years old
  • Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
  • Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
  • Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \[PAWSS\] > 4 at admission)
  • Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \[CIWA-Ar\] ≥ 8 at screening)
  • Positive urine test for alcohol at screening
  • Be able to provide written informed consent
  • Female subjects must be non-nursing and not pregnant
  • Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.

Exclusion criteria

  • In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
  • Current use of tobacco
  • Is pregnant or nursing
  • Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
  • Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Menninger Clinic — Houston

Identifiers

NCT: NCT07281261 · SBM-AUD-01 · H-56001 · R41AA032157

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗