An Exploratory Preliminary Study on the Effect of Combined Transcranial Photobiomodulation(tPBM)-Transauricular Vagus Nerve Stimulation(taVNS) on Alcohol Craving and Neurophysiological Marker in Drinkers (in South Korea)

NCT07071493 | Enrolling By Invitation

• 2 other identifiers: A-STEAM-2024-01RS-2024-00420674
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Study Summary This pilot study aims to explore the mechanisms and effects of non-invasive neurostimulation in individuals with alcohol use, in order to develop a more accessible and sustainable treatment approach for alcohol use disorder. Objectives To evaluate the impact of: Transcranial photobiomodulation (tPBM) Transcutaneous auricular vagus nerve stimulation (taVNS) Combined tPBM + taVNS on alcohol craving and neurophysiological indicators. Method Participants: 60 adults (30 at Severance Hospital, 30 at Samsung Medical Center) Design: Randomized into 3 groups (tPBM, taVNS, combined) Intervention: 15 minutes/day, 5 days/week for 5 weeks (home-based) Assessments: Questionnaires, neurocognitive tests, EEG, and heart rate variability (HRV) Safety: Weekly phone check-ins for monitoring adverse effects Follow-up: Post-intervention assessments after 5 weeks

Conditions

Normal Subjects

Outcome Measures

Primary Outcomes (1)

• Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)

  The Pennsylvania Alcohol Craving Scale (PACS) consists of 5 items, each rated on a scale from 0 to 6. The scale comprehensively assesses the frequency, intensity, and duration of alcohol craving, as well as the individual's ability to resist drinking. The total score ranges from 0 to 30, with a score of 20 or higher indicating a level consistent with a substance use disorder. To evaluate changes in alcohol craving before and after a 5-week brain stimulation intervention using the Penn Alcohol Craving Scale (PACS). The study will compare the change in craving scores across three groups: combined stimulation (tPBM+taVNS), tPBM-only, and taVNS-only.

  Administered at baseline (V1), five weeks (V2)

Secondary Outcomes (15)

• Change in EEG-Based Neurophysiological Markers

  Administered at baseline (V1), five weeks (V2)

• Change in Heart Rate Variability (HRV)

  Administered at baseline (V1), five weeks (V2)

• Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT)

  Administered at baseline (V1), five weeks (V2)

• Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R)

  Administered at baseline (V1), five weeks (V2)

• Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI).

  Administered at baseline (V1), five weeks (V2)

Study Arms (1)

Three Group Intervention Studies

EXPERIMENTAL

\* Stimulation Program (5 Weeks) Each participant will follow one of the following programs, assigned randomly, five days a week for a total duration of five weeks. 1. tPBM Group: Participants will receive transcranial photobiomodulation (tPBM) for 15 minutes per day. 2. taVNS Group: Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) for 15 minutes per day. 3. Combined Treatment Group: Participants will simultaneously receive both tPBM and taVNS for 15 minutes per day.

Device: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)

Interventions

tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks) DEVICE

Stimulation Program (5 Weeks) Each participant will follow one of the following programs, assigned randomly, five days a week for a total duration of five weeks. tPBM Group: Participants will receive transcranial photobiomodulation (tPBM) for 15 minutes per day. taVNS Group: Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) for 15 minutes per day. Combined Treatment Group: Participants will simultaneously receive both tPBM and taVNS for 15 minutes per day.

Three Group Intervention Studies

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 19 and 40 years who are able to provide valid written informed consent.
• Individuals who consume alcohol, have an AUDIT-K score of 4 or higher, and do not meet the DSM-5 criteria for alcohol use disorder.
• Individuals who are capable of completing the 5-week stimulation program.
• Individuals who voluntarily agree to participate and sign the informed consent form.

You may not qualify if:

• Individuals who cannot read or understand the informed consent (e.g., illiterate individuals, non-Korean speakers).
• Individuals with impaired decision-making capacity.
• Pregnant women.
• Vulnerable populations, including individuals employed by or under the supervision of the research institution, investigators, or sponsors (e.g., employees, students, military personnel).
• Individuals unable to comply with the 5-week stimulation protocol.
• Individuals diagnosed with alcohol use disorder according to DSM-5 criteria.
• Individuals diagnosed with a substance use disorder other than alcohol or nicotine.
• Individuals with metal allergies that may interfere with EEG or stimulation devices.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (2)

Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Officials

• Young-Chul Jung, Professor, MD, PhD

  Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 17, 2025
• Study Start: January 15, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)