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.
Male or female (evenly recruited) aged 18-64 years old
Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] > 4 at admission)
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
Current use of tobacco
Is pregnant or nursing
Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
Parallel
Sparrow Ascent
DeviceThe 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.
Sparrow Ascent (Sham)
DeviceParticipants 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.
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal.
Average benzodiazepine use
Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal.
Penn Alcohol Craving Scale (PACS)
PACS is a validated self-report questionnaire that measures the intensity, frequency, and duration of alcohol craving over the past week. It consists of five items assessing desire to drink, anticipated likelihood of drinking, and perceived control over drinking-related thoughts. Each item is rated on a 0-6 scale, with higher total scores indicating greater craving severity.
Montgomery-Asberg Depression Scale (MADRS)
MADRS is a clinician-administered measure designed to assess the severity of depressive symptoms. The scale includes 10 items that evaluate core features of depression such as mood, anxiety, sleep disturbance, concentration, and suicidal ideation. Each item is scored from 0 to 6, with higher total scores indicating more severe depression.
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
SBQ-R is a validated, self-report measure used to assess past suicidal thoughts and behaviors, as well as current risk. The questionnaire includes four items that evaluate lifetime suicidal ideation and attempts, recent ideation, threat of future suicidal behavior, and self-reported likelihood of acting on suicidal thoughts. Scores range from low to high risk, with higher scores indicating greater concern for suicidal behavior.
Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
PAWSS is a validated clinician-administered screening tool used to identify individuals at risk for developing moderate to severe alcohol withdrawal. The scale includes 10 items assessing historical, clinical, and laboratory factors associated with withdrawal risk. A total score of 4 or higher indicates high risk for complicated withdrawal.
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Spark Biomedical, Inc.
Lead sponsor
The Menninger Clinic
Collaborator
Baylor College of Medicine
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
