tAN for Substance Use Disorder

NCT ID: NCT07281261

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sparrow Ascent

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sparrow Ascent (Sham)

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Transcutaneous Auricular Neurostimulation; Transcutaneous Auricular Neurostimulation (Sham)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Menninger Clinic

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Spark Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Navid Khodaparast, PhD

Role: PRINCIPAL_INVESTIGATOR

Spark Biomedical, Inc.

Locations

The Menninger Clinic

Houston, Texas, United States

Countries

United States

Central Contacts

Hyuntaek Oh, PhD

Role: CONTACT

hyuntaek.oh@bcm.edu

(713) 275-5019

Caroline Benner

Role: CONTACT

clinicaltrials@sparkbiomedical.com

(210) 624-8046

Facility Contacts

Hyuntaek Oh, PhD

Role: primary

hyuntaek.oh@bcm.edu

713-275-5019

Other Identifiers

H-56001

Identifier Type: OTHER

Identifier Source: secondary_id

R41AA032157

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBM-AUD-01

Identifier Type: -

Identifier Source: org_study_id