Transcutaneous auricular neurostimulation (tAN) for reducing alcohol withdrawal in people with alcohol use disorder
Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
This trial will try a five-day ear‑stimulation device (tAN) versus a sham device to reduce alcohol withdrawal symptoms in adults with moderate-to-severe alcohol use disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Spark Biomedical, Inc. Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07281261 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–64 with DSM-5 moderate-or-higher alcohol use disorder who show high risk for moderate-to-severe withdrawal (PAWSS > 4 and CIWA‑Ar > 15), test positive for alcohol, can consent, are MRI-eligible, and are not pregnant or nursing are appropriate candidates.
Not a fit: People with mild alcohol problems, low predicted withdrawal risk, inability to undergo MRI, unstable medical/psychiatric conditions, or who cannot remain on-site for the five-day detox are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could lessen alcohol withdrawal severity, reduce benzodiazepine needs, and improve clinical outcomes during early detoxification.
How similar studies have performed: There is limited preliminary evidence that auricular neurostimulation can affect craving and withdrawal-related symptoms, but application specifically to alcohol withdrawal with concurrent MRI is relatively novel and early-stage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.