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New treatment option for Heavy Drinking
Official title Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
ClinicalTrials.gov ID: NCT07516873
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 29
You may be able to join if
- 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.
You likely can't join if
- Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of...
- 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Malden, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malden, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.