Research on the Heart-Brain Coupling Mechanisms and Interventions for Emotional Inhibitory Control Deficits in Individuals With Alcohol Use Disorder

NCT07036055 | Completed DMC

• 1 other identifier: JDu-015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with mindfulness training can improve emotional inhibitory control in adults with Alcohol Use Disorder (AUD). The study also aims to explore the brain-heart coupling mechanisms underlying these control deficits. The main questions it aims to answer are: Do individuals with AUD have abnormal brain-heart coupling associated with impaired emotional inhibitory control? Can taVNS combined with mindfulness training enhance emotional inhibitory control in individuals with AUD compared to sham stimulation? Researchers will compare a group receiving taVNS plus mindfulness training to a group receiving sham stimulation plus mindfulness training to see whether the active intervention improves behavioral performance and brain-heart coupling. Participants will: Complete an emotional Go/NoGo task while EEG and ECG data are recorded Receive 10 days of either real or sham taVNS combined with mindfulness training Complete questionnaires and cognitive assessments before and after the intervention

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder (AUD); transcutaneous auricular vagus nerve stimulation (taVNS); brain-heart coupling; mindfulness meditation

Outcome Measures

Primary Outcomes (1)

• Emotional Inhibitory Control Performance in Emotional Go/NoGo Task

  Emotional inhibitory control performance will be assessed based on participants' accuracy in the emotional Go/NoGo task (i.e., proportion of correctly inhibited responses on NoGo trials). The task uses emotionally valenced facial stimuli and requires participants to withhold responses under emotional interference. Accuracy reflects participants' inhibitory control under affective load, which is the primary behavioral index of intervention efficacy.

  Assessed at baseline (Day 0) and post-intervention (Day 11)

Secondary Outcomes (4)

• Drift Rate Estimated by Hierarchical Drift Diffusion Model (HDDM)

  Assessed at baseline (Day 0) and post-intervention (Day 11)

• Brain-Heart Coupling Strength (HRV-EEG Coupling)

  Assessed at baseline (Day 0) and post-intervention (Day 11)

• Self-Reported Emotion Regulation Ability (DERS Score)

  Assessed at baseline (Day 0) and post-intervention (Day 11)

• Alcohol Craving (Visual Analog Scale)

  Assessed at Day 0, Day 3, Day 6, Day 11

Other Outcomes (2)

• Anxiety Symptoms (GAD-7 Score)

  Assessed at Day 0, Day 3, Day 6, Day 11

• Depressive Symptoms (PHQ-9 Score)

  Assessed at Day 0, Day 3, Day 6, Day 11

Study Arms (2)

taVNS + Mindfulness Training

EXPERIMENTAL

Participants in this group will receive 30-minute daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standardized mindfulness training for 10 consecutive days. taVNS is delivered using a wearable device targeting the cymba conchae area of the ear. Stimulation parameters include a frequency of 25 Hz and a pulse width of 200 µs. Mindfulness training involves guided audio practice focused on breath awareness and body scanning.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Behavioral: Mindfulness Training

Sham Stimulation + Mindfulness Training

SHAM COMPARATOR

Participants in this group will receive 30-minute daily sessions of sham stimulation (identical device without active current) combined with the same mindfulness training protocol as the experimental group, administered for 10 consecutive days. The sham stimulation mimics the appearance and procedure of active taVNS but delivers no electrical stimulation.

Device: Sham Stimulation; Behavioral: Mindfulness Training

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) DEVICE

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) via a non-invasive ear-clip device targeting the cymba conchae. The device delivers electrical pulses at 25 Hz frequency with a pulse width of 200 µs, for 30 minutes daily over 10 consecutive days. The stimulation intensity is individually adjusted to the participant's perceptual threshold. taVNS is paired with standardized mindfulness training in this arm.

Also known as: taVNS, Auricular Vagus Nerve Stimulation

taVNS + Mindfulness Training

Sham Stimulation DEVICE

Participants in this group use the same device as in the active taVNS condition, but the stimulation is deactivated. The ear-clip device is placed identically on the cymba conchae, with no electrical current delivered. This sham procedure mimics the look and feel of taVNS but serves as a placebo control. Sham stimulation is combined with the same mindfulness training as the experimental group.

Sham Stimulation + Mindfulness Training

Mindfulness Training BEHAVIORAL

Participants receive instructor-led mindfulness training conducted by a trained therapist. Each session lasts 30 minutes and focuses on breath awareness, body scanning, and non-judgmental awareness of internal experience. All participants (both taVNS and sham groups) receive this training daily for 10 consecutive days.

Also known as: Mindfulness Meditation, Guided Mindfulness Practice

Sham Stimulation + Mindfulness Training; taVNS + Mindfulness Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-5 diagnostic criteria for Alcohol Use Disorder (AUD).
• Aged 18-55 years.
• Currently in the post-acute withdrawal phase (≥2 weeks since last alcohol use).
• No severe psychiatric comorbidities (e.g., schizophrenia, bipolar disorder).
• No neurological disorders (e.g., epilepsy, traumatic brain injury).
• Willing to provide informed consent.

You may not qualify if:

• Dependence on other substances (except nicotine).
• Severe physical illness requiring immediate treatment.
• Active infectious diseases (e.g., HIV, hepatitis).
• Inability to complete study procedures (e.g., cognitive impairment).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

China

Mengzi, Yunnan, 661199, China

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jiang Du, M.D

  Shanghai Mental Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: March 15, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be available starting 6 months after publication of the primary results and will remain available for 3 years.
• Access Criteria: IPD will be shared with qualified researchers affiliated with academic or non-profit institutions, for secondary analyses that are methodologically sound and ethically approved. Requests will be reviewed by the principal investigator and must include a study proposal, data use agreement, and proof of institutional ethics approval.

Locations

CN (1)