Mindfulness + Vagal Nerve Stimulation for Alcoholism

Overseen By Frannie Marin, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Must not be taking: Sedatives, Opioids, AUD medications

Disqualifiers: Substance use disorder, Psychosis, Bipolar, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In the present study, we will assess the acceptability and feasibility of a brief intervention designed to help young heavy drinkers reduce their alcohol consumption. All participants will complete a brief (1-week) mindfulness intervention, and participants will be randomized to receive either active or inactive Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) during two in-person laboratory visits. Heart rate variability data and self-report durvey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.

Who Is on the Research Team?

Zev Schuman-Olivier, MD

Principal Investigator

Cambridge Health Alliance

Are You a Good Fit for This Trial?

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.

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

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

How Is the Trial Designed?

Group I: Active RAVANS Experimental Treatment 2 Interventions

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.

Group II: Inactive RAVANS Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+