💬In plain words
What the trial is, and whether it could suit you
The present study 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 survey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Currently living in Massachusetts.
* Aged 21-29 years old.
* 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).
* Have sufficient English fluency to understand procedures and questionnaires.
* Have the capacity and ability to provide informed consent.
* Scores at least 15 points on the PACS at screening. Participants who score between 10 and 14 pts will undergo additional doctoral-level review to assess eligibility.
Exclusion Criteria:
* Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Module C (Substance Use Disorders).
* Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
* Active prescription for medications used to treat alcohol use disorder (AUD), e.g., naltrexone, disulfiram, acamprosate, etc.
* Active psychosis or schizophrenia-spectrum disorder diagnosis.
* Bipolar I disorder history or severe level of mania.
* Severe symptoms of PTSD.
* Acute suicidality or self-injurious behavior.
* Cognitive inability as demonstrated by the inability to complete an informed consent assessment with \>90% accuracy after 2 attempts.
* Current participation in another experimental intervention research study.
* Current daily mindfulness practice \>10 minutes per day.
* Participation in an 8-week intensive Mindfulness-Based Intervention or residential meditation retreat in past 3 years.
* Expected medical hospitalization in the next 2 months; or are currently pregnant.
* Expected incarceration in the next 2 months.
* Presence of electronic implants, such as heart pacemakers, defibrillators, or pumps.
* Presence of a cardiac rhythm disorder.
* History of seizures.
* Presence of skin disorders or malignant diseases in the area in or around the left ear.
* Lack of alcohol craving as assessed by the PACS during screening (score of \< 10 points).
💊
What it tests
- Active RAVANS
- Brief Mindfulness-Based Intervention
Center for Mindfulness and Compassion
Malden, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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