Transcutaneous auricular neurostimulation (tAN) for reducing alcohol withdrawal in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with moderate or worse alcohol use disorder who meet high-risk withdrawal criteria will be randomized, single-blind, to receive either active transcutaneous auricular neurostimulation (tAN) or a sham device while undergoing a five-day on-site detoxification at The Menninger Clinic. Clinical measures including CIWA-Ar withdrawal scores, craving, benzodiazepine use, and assessments of depression and suicidal behaviors will be collected before, during, and after the treatment period. Participants will have MRI scans before and after the five-day treatment to measure changes in resting-state functional connectivity between orbitofrontal cortex and striatum and relate those changes to clinical outcomes. The protocol compares active versus sham stimulation to determine whether tAN can shorten or lessen the severity of alcohol withdrawal and alter relevant brain circuitry.

Why it matters

Who can join: the full rules

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

Where it's running

• The Menninger Clinic
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Navid Khodaparast, PhD — Spark Biomedical, Inc.
• Study coordinator: Hyuntaek Oh, PhD
• Email: hyuntaek.oh@bcm.edu
• Phone: (713) 275-5019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.