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tAN for Substance Use Disorder | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

tAN for Substance Use Disorder

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

NCT07281261•Spark Biomedical, Inc.

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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 \[CIWA-Ar\] \> 15 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

Locations (1)

The Menninger Clinic

Houston, Texas, United States

Key Dates

Start Date

January 31, 2026

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Alcohol Use DisorderAlcohol AbuseSubstance Use DisordersSubstance Use Disorders Alcohol Use Withdrawal State

Interventions

Sparrow Ascent

DEVICE

Sparrow Ascent (Sham)

DEVICE

Contacts

Hyuntaek Oh, PhD

CONTACT

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

Caroline Benner

CONTACT

(210) 624-8046 clinicaltrials@sparkbiomedical.com

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

NCT04197921

Opioid-use DisorderSubstance Use Disorders

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RECRUITINGNA

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

NCT05855668

Alcohol Use DisorderCannabis Use Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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tAN for Substance Use Disorder

Inclusion Criteria

Exclusion Criteria

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

Virtual Reality (VR) NATURE - Alcohol Use Disorder (AUD)

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Temporal Interference Methods for Addiction Treatment