Recruiting

tAN

Sponsor:

Spark Biomedical, Inc.

Code:

NCT07281261

Conditions

Alcohol Use Disorder

Alcohol Abuse

Substance Use Disorders

Substance Use Disorders Alcohol Use Withdrawal State

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Sparrow Ascent

Sparrow Ascent (Sham)

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Alcohol Abuse

Substance Use Disorders

Substance Use Disorders Alcohol Use Withdrawal State

Study ID

NCT07281261

Start date

Jan 28, 2026

Status verified date

Jun, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Current use of tobacco
3. Is pregnant or nursing
4. Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
5. Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tAN

Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment.

sham comparator: Sham tAN

Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment.

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Hyuntaek Oh, PhD

(713) 275-5019hyuntaek.oh@bcm.edu

Caroline Benner

(210) 624-8046clinicaltrials@sparkbiomedical.com

Locations

The Menninger Clinic

Recruiting

Houston, Texas, United States, 77035

Contacts

Elisabeth Stevens

713-275-2896estevens@menninger.edu

Principal Investigator:

Hyuntaek Oh, PhD

More Information

Sponsor

Spark Biomedical, Inc.

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Alcohol
  • Alcohol Use Disorder
  • Substance Use Disorder
  • Transcutaneous Auricular Neurostimulation
  • tAN
  • Neurostimulation
  • Vagus Nerve Stimulation
  • Auricular Neurostimulation
  • Transcutaneous

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Spark Biomedical, Inc. on 2026-06-02.