tAN for Substance Use Disorder
Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
- Alcohol Use Disorder
- Alcohol Abuse
- Substance Use Disorders
- Substance Use Disorders Alcohol Use Withdrawal State
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Spark Biomedical, Inc.
- Enrolment target
- 20
- Started
- 28 January 2026
- Main results due
- 31 August 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 64 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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 \[CIWA-Ar\] ≥ 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
The Menninger Clinic
Houston, Texas, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07281261. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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