Transcutaneous Auricular Neurostimulation for Alcohol Use Disorder
This study aims to evaluate whether transcutaneous auricular neurostimulation can help reduce alcohol withdrawal symptoms in people with alcohol use disorder.
Sparrow Ascent
+ Sparrow Ascent (Sham)
Alcoholism+2
+ Mental Disorders
+ Substance-Related Disorders
Treatment Study
Summary
Study start date: January 31, 2026
Actual date on which the first participant was enrolled.This study is exploring a new method to help people with Alcohol Use Disorder (AUD) who are going through alcohol withdrawal. It aims to see if a device that stimulates nerves in the ear, called transcutaneous auricular neurostimulation (tAN), can reduce the symptoms of withdrawal and change how certain parts of the brain communicate with each other. The study is especially important because managing alcohol withdrawal can be challenging, and this new approach could offer an alternative to traditional medication. Participants will include individuals experiencing alcohol withdrawal symptoms, and the results could lead to better treatment options for those struggling with AUD. Participants will be divided into two groups, with one group receiving the active tAN treatment and the other receiving a sham, or placebo, version. The tAN device will be worn at The Menninger Clinic for five days during the detox period. Researchers will assess participants at various stages: before treatment, during the treatment, and after the treatment. They will measure how severe the withdrawal symptoms are, the level of alcohol cravings, and any use of benzodiazepines, which are drugs often used to ease withdrawal symptoms. Participants will also have MRI scans to see if the treatment impacts brain connectivity. These measures help determine the effectiveness of the tAN device in reducing withdrawal symptoms and improving overall brain function.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location