Mindfulness + Vagal Nerve Stimulation for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help young adults reduce alcohol intake using mindfulness and a device that may stimulate certain nerves to manage stress. Participants will receive a Brief Mindfulness-Based Intervention and use a device that either provides gentle nerve stimulation (Active RAVANS, a vagal nerve stimulation device) or no stimulation. The trial aims to assess how these methods affect heart rate, stress levels, and drinking habits. It is suitable for young adults in Massachusetts who drink heavily, such as consuming more than 14 drinks a week or 5 drinks in one day. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new ways of managing alcohol consumption and stress.
Will I have to stop taking my current medications?
If you are currently taking medications for alcohol use disorder or sedatives, hypnotics, opioids, or anesthetics, you cannot participate in this trial. The protocol does not specify other medication restrictions.
What prior data suggests that this mindfulness and vagal nerve stimulation intervention is safe for young heavy drinkers?
Research has shown that auricular transcutaneous vagus nerve stimulation (taVNS) is generally safe. Studies have found it helps reduce withdrawal symptoms in people with alcohol use disorder. In a study with 40 participants, taVNS caused no major side effects and was well-tolerated. Some participants experienced mild side effects like skin tingling, but these were not serious.
For the mindfulness-based intervention, research results are mixed. Some studies suggest it helps reduce stress and substance use. However, no strong evidence indicates serious side effects from mindfulness practices. It is generally considered safe and might support other treatments.
In summary, both treatments in the trial appear well-tolerated. Neither has shown serious safety concerns in past research.12345Why are researchers excited about this trial?
Researchers are excited about combining mindfulness with vagal nerve stimulation for treating alcoholism because it offers a novel approach that differs significantly from traditional methods like medications (such as disulfiram or naltrexone) and behavioral therapies. The unique feature of this treatment is the use of a RAVANS device that delivers non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) specifically during exhalation, which is believed to enhance the calming effects of mindful breathing. This method not only aims to reduce alcohol cravings by stimulating the vagus nerve but also potentially improves emotional regulation and stress management, which are critical components in overcoming addiction. By integrating mindfulness practices with a physiological intervention, this approach could offer a more holistic and effective treatment for individuals struggling with alcoholism.
What evidence suggests that this trial's treatments could be effective for alcoholism?
This trial will compare two approaches for treating alcohol use disorder (AUD): the active RAVANS device and a Brief Mindfulness-Based Intervention. Research has shown that stimulating the vagal nerve, as with the active RAVANS device, can ease withdrawal symptoms and boost mood in people with AUD. It might also reduce anxiety and depression, common in those dealing with alcohol dependence. Some studies suggest it can improve sleep and help manage cravings.
Mindfulness-based interventions (MBIs) have been found to slightly to moderately reduce alcohol use. They may also help manage stress and impulsive behavior. Evidence indicates that MBIs can increase the chances of staying sober and reduce cravings in people with substance use problems. While more research is needed, these methods show promise in helping to lower alcohol consumption.12346Who Is on the Research Team?
Zev Schuman-Olivier, MD
Principal Investigator
Cambridge Health Alliance
Are You a Good Fit for This Trial?
This trial is for young adults aged 21-29 living in Massachusetts who drink heavily (over 14 drinks per week or binge at least once a week), have alcohol cravings, and can understand English. People with certain mental health conditions, medical devices, some medications, or recent intensive mindfulness experience cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Week
Participants engage in daily mindfulness practice with audio meditation
Lab Visits
Participants attend two lab visits for RAVANS stimulation and mindfulness training
Follow-up
Participants complete follow-up surveys to assess intervention impact
What Are the Treatments Tested in This Trial?
Interventions
- Active RAVANS
- Brief Mindfulness-Based Intervention
Trial Overview
The study tests if a short mindfulness program combined with either active or inactive vagal nerve stimulation (RAVANS) helps reduce alcohol cravings and drinking among heavy-drinking young adults. Participants are randomly assigned to receive either the real or fake nerve stimulation during two lab visits.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
These participants will use a RAVANS device set to deliver non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) to stimulate vagal afferent nerve fibers exclusively during exhalation. Participants will be asked to use this device during two lab visits one week apart: Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute device session. Visit 2: Participants will have one 30-minute device session with concurrent mindful breathing followed by a 5-minute session with the device while viewing alcohol-related visual cues.
These participants will employ a RAVANS device in sham mode, in which the device will not deliver electrical stimulation. Participants will be asked to use this device during two lab visits one week apart: Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute inactive device session. Visit 2: Participants will have one sham 30-minute device session with concurrent mindful breathing followed by a sham 5-minute session with the device while viewing alcohol-related visual cues.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cambridge Health Alliance
Lead Sponsor
Citations
Noninvasive Vagus Nerve Stimulation Reduces ...
Noninvasive Vagus Nerve Stimulation Reduces Withdrawal-Related Affective Distress and Improves Functional Outcomes in Alcohol Use Disorder: A Feasibility and ...
Vagal Nerve Stimulation for Alcoholism
Studies have found that this nerve stimulation can lift mood and lessen anxiety and depression, common in people with AUD. It has also helped with conditions ...
Auricular transcutaneous vagus nerve stimulation for ...
This approach has been demonstrated to be successful in modulating the tonic and phasic modes of the LC-NA system as well as cognitive processes ...
Auricular transcutaneous vagus nerve stimulation for ...
We discuss the potential use of auricular transcutaneous vagus nerve stimulation (atVNS) as an ADD-ON intervention in AUD.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS ...
The overall objective of this study is to demonstrate that transcutaneous auricular vagus nerve stimulation (taVNS) therapy is a safe and feasible treatment ...
6.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/09000/efficacy_and_safety_of_transcutaneous_auricular.33.aspxEfficacy and Safety of Transcutaneous Auricular Vagus ...
Conducted in China, the study involved 40 participants over four weeks. Results showed that taVNS significantly improved bowel movement frequency, stool ...
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