50 Participants NeededMy employer runs this trial

Mindfulness + Vagal Nerve Stimulation for Alcoholism

MD
FM
Overseen ByFrannie Marin, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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.12346

Who Is on the Research Team?

ZS

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

Consume either more than 14 standard drinks of alcohol per week OR at least 5 standard drinks in one day per week (in past 30 days)
I am between 21 and 29 years old.
I am able to understand the study and give my consent to participate.
See 3 more

Exclusion Criteria

Active psychosis or schizophrenia-spectrum disorder diagnosis
I have taken part in an 8-week mindfulness program or meditation retreat in the last 3 years.
Acute suicidality or self-injurious behavior
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Intervention Week

Participants engage in daily mindfulness practice with audio meditation

1 week
Daily practice (self-guided)

Lab Visits

Participants attend two lab visits for RAVANS stimulation and mindfulness training

2 weeks
2 visits (in-person)

Follow-up

Participants complete follow-up surveys to assess intervention impact

1 week
1 visit (virtual)

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

Group I: Active RAVANSExperimental Treatment2 Interventions
Group II: Inactive RAVANSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials
65
Recruited
22,400+

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36001426/

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 ...

Efficacy 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 ...