tAN for Substance Use Disorder

NCT07281261 | Recruiting DMC FDA Device

• 3 other identifiers: SBM-AUD-01H-56001R41AA032157
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 Abuse; Substance Use Disorders; Substance Use Disorders Alcohol Use Withdrawal State; Alcohol Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)

  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.

  Every 4 hours during the tAN treatment (Days 2-6)

• Average benzodiazepine use

  Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal.

  Every 4 hours during the tAN treatment (Days 2-6)

Secondary Outcomes (3)

• Penn Alcohol Craving Scale (PACS)

  Before Day 2 and after tAN treatment on Day 6

• Montgomery-Asberg Depression Scale (MADRS)

  Before Day 2 and after tAN treatment on Day 6

• Suicidal Behaviors Questionnaire-Revised (SBQ-R)

  Before Day 2 and after tAN treatment on Day 6

Other Outcomes (1)

• Prediction of Alcohol Withdrawal Severity Scale (PAWSS)

  Screening

Study Arms (2)

Active tAN

EXPERIMENTAL

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.

Device: Sparrow Ascent

Sham tAN

SHAM COMPARATOR

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.

Device: Sparrow Ascent (Sham)

Interventions

Sparrow Ascent DEVICE

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.

Also known as: Transcutaneous Auricular Neurostimulation

Active tAN

Sparrow Ascent (Sham) DEVICE

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.

Also known as: Transcutaneous Auricular Neurostimulation (Sham)

Sham tAN

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[CIWA-Ar\] \> 15 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• The Menninger Clinic: collaborator
• Baylor College of Medicine: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Menninger Clinic

Houston, Texas, 77035, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Navid Khodaparast, PhD

  Spark Biomedical, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuntaek Oh, PhD

CONTACT

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

Caroline Benner

CONTACT

(210) 624-8046; clinicaltrials@sparkbiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a randomized, single-blind, sham-controlled trial. Participants will be randomized in a 1:1 ratio to one of two treatment groups: (1) Active tAN and (2) Sham tAN

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)