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NCT Number: NCT07281261

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) 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.

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Key information

Conditions

Alcohol Use Disorder Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance Use Disorders Substance Use Disorders Alcohol Use Withdrawal State Substance-Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Menninger Clinic

Houston, Texas, 77035, United States

Location status: Recruiting

Location contact

Daryl Shorter, MD

SUB_INVESTIGATOR

Elisabeth Stevens

CONTACT

[email protected]

713-275-2896

Hyuntaek Oh, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Transcutaneous Auricular Neurostimulation

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.

Other names: Transcutaneous Auricular Neurostimulation (Sham)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Benner

CONTACT

[email protected]

(210) 624-8046

Hyuntaek Oh, PhD

CONTACT

[email protected]

(713) 275-5019

Sponsors and collaborators

Lead sponsor

Spark Biomedical, Inc.

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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