NCT07281261 · Spark Biomedical, Inc.
tAN for Substance Use Disorder
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
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.
Primary outcome measures
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Time frame: Every 4 hours during the tAN treatment (Days 2-6)
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
Time frame: Every 4 hours during the tAN treatment (Days 2-6)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \[CIWA-Ar\] ≥ 8 at screening)
- Positive urine test for alcohol at screening
- Be able to provide written informed consent
- Female subjects must be non-nursing and not pregnant
- Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.
Exclusion criteria
- 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.)
- Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
Where
- Houston, Texas
Collaborators
The Menninger Clinic, Baylor College of Medicine, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2026 · Source of record for eligibility and locations