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)

NCT ID: NCT07071493

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Three Group Intervention Studies

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults aged between 19 and 40 years who are able to provide valid written informed consent.

2. 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.

3. Individuals who are capable of completing the 5-week stimulation program.

4. Individuals who voluntarily agree to participate and sign the informed consent form.

Exclusion Criteria

1. Individuals who cannot read or understand the informed consent (e.g., illiterate individuals, non-Korean speakers).

2. Individuals with impaired decision-making capacity.

3. Pregnant women.

4. Vulnerable populations, including individuals employed by or under the supervision of the research institution, investigators, or sponsors (e.g., employees, students, military personnel).

5. Individuals unable to comply with the 5-week stimulation protocol.

6. Individuals diagnosed with alcohol use disorder according to DSM-5 criteria.

7. Individuals diagnosed with a substance use disorder other than alcohol or nicotine.

8. Individuals with metal allergies that may interfere with EEG or stimulation devices.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Chul Jung, Professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Severance Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RS-2024-00420674

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

A-STEAM-2024-01

Identifier Type: -

Identifier Source: org_study_id