tAN for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called transcutaneous auricular neurostimulation (tAN) to help individuals with alcohol use disorder (AUD) manage withdrawal symptoms. Participants will wear a tAN device for a few hours each day to determine if it reduces withdrawal severity and alters brain activity related to cravings and mood. The study includes a treatment group receiving active tAN and a placebo group with a sham device. It suits those with moderate to severe AUD experiencing withdrawal symptoms. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatment options for AUD.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What prior data suggests that this tAN device is safe for treating alcohol use disorder?
Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe for people. One study found that tAN effectively reduces symptoms of opioid withdrawal. This research led to FDA clearance, indicating a strong safety record.
While researchers continue to study tAN's effectiveness for alcohol withdrawal, its safety in similar situations is promising. Participants in past studies have typically tolerated tAN well, with few side effects reported. For those considering joining a trial, these findings suggest that tAN could be a safe option.12345Why are researchers excited about this trial?
Transcranial alternating current stimulation (tAN) is unique because it offers a non-invasive approach to treating alcoholism by using gentle electrical currents to stimulate the brain. Unlike current treatments, which often include medications like disulfiram or naltrexone, and behavioral therapies, tAN directly targets brain activity patterns associated with addiction. Researchers are excited about tAN because it has the potential to enhance traditional therapies by modulating neural circuits without the side effects typically associated with medication. Additionally, the possibility of combining tAN with a patient's standard care could offer a more comprehensive approach to managing alcoholism.
What evidence suggests that the tAN device is effective for alcohol use disorder?
Research shows that transcutaneous auricular neurostimulation (tAN) might help manage symptoms when people stop drinking alcohol. One study found that similar noninvasive nerve stimulation methods reduced distress in people with alcohol use disorder. Another study suggested that stimulating the ear's vagus nerve improved depression and sleep in those who had stopped drinking. These early findings suggest tAN might work by altering brain connectivity, potentially aiding in managing withdrawal symptoms. In this trial, participants will receive either active tAN or sham tAN to further study its benefits in alcohol use disorder. These studies offer promising signs.36789
Who Is on the Research Team?
Navid Khodaparast, PhD
Principal Investigator
Spark Biomedical, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with alcohol use disorder (AUD) who are experiencing withdrawal. They'll be at The Menninger Clinic for a 5-day detox, where they'll wear the tAN device. Participants must meet certain health criteria and will be randomly assigned to either the active treatment or a placebo group.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including clinical measures and MRI scans are conducted
tAN Treatment
Participants undergo a 5-day tAN treatment to attenuate alcohol withdrawal syndrome and alter resting state functional connectivity
Post tAN Treatment
Post-treatment assessments including clinical measures and MRI scans are conducted
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- tAN
Trial Overview
The study tests if a 5-day transcranial auricular nerve stimulation (tAN) can ease alcohol withdrawal symptoms and change brain connectivity in AUD patients. It compares an active tAN treatment against a sham version, monitoring effects through clinical assessments and MRI scans before and after treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment.
Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spark Biomedical, Inc.
Lead Sponsor
The Menninger Clinic
Collaborator
Baylor College of Medicine
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06771037?term=CHLORDIAZEPOXIDE&viewType=Table&rank=10Use of tAN® in Alcohol Withdrawal Management
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Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.
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Here, we discuss the potential use of auricular transcutaneous vagus nerve stimulation (atVNS) as an ADD-ON intervention in AUD.
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