tAN for Substance Use Disorder

June 1, 2026 updated by: Spark Biomedical, Inc.

Study of Transcutaneous Auricular Neurostimulation as a Treatment 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) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77035
        • Recruiting
        • The Menninger Clinic
        • Principal Investigator:
          • Hyuntaek Oh, PhD
        • Sub-Investigator:
          • Daryl Shorter, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Transcutaneous Auricular Neurostimulation
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.
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.
Other Names:
  • Transcutaneous Auricular Neurostimulation (Sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Time Frame: Every 4 hours during the tAN treatment (Days 2-6)
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
Time Frame: Every 4 hours during the tAN treatment (Days 2-6)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penn Alcohol Craving Scale (PACS)
Time Frame: Before Day 2 and after tAN treatment on Day 6
PACS is a validated self-report questionnaire that measures the intensity, frequency, and duration of alcohol craving over the past week. It consists of five items assessing desire to drink, anticipated likelihood of drinking, and perceived control over drinking-related thoughts. Each item is rated on a 0-6 scale, with higher total scores indicating greater craving severity.
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
MADRS is a clinician-administered measure designed to assess the severity of depressive symptoms. The scale includes 10 items that evaluate core features of depression such as mood, anxiety, sleep disturbance, concentration, and suicidal ideation. Each item is scored from 0 to 6, with higher total scores indicating more severe depression.
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
SBQ-R is a validated, self-report measure used to assess past suicidal thoughts and behaviors, as well as current risk. The questionnaire includes four items that evaluate lifetime suicidal ideation and attempts, recent ideation, threat of future suicidal behavior, and self-reported likelihood of acting on suicidal thoughts. Scores range from low to high risk, with higher scores indicating greater concern for suicidal behavior.
Before Day 2 and after tAN treatment on Day 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
Time Frame: Screening
PAWSS is a validated clinician-administered screening tool used to identify individuals at risk for developing moderate to severe alcohol withdrawal. The scale includes 10 items assessing historical, clinical, and laboratory factors associated with withdrawal risk. A total score of 4 or higher indicates high risk for complicated withdrawal.
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spark Biomedical, Inc.

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Baylor College of Medicine
The Menninger Clinic

Investigators

  • Principal Investigator: Navid Khodaparast, PhD, Spark Biomedical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBM-AUD-01
  • H-56001 (Other Identifier: Baylor College of Medicine)
  • R41AA032157 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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