24
Participants
Start Date
May 30, 2025
Primary Completion Date
December 1, 2025
Study Completion Date
April 6, 2026
Neurostimulation
Participants in this group will use the physical device for medical use (ADTPM 1) applied to the auricular region (ear and surrounding area) for 60 minutes (±10 minutes) per session, at least once daily and a minimum of 7 times per week, over a 4-week treatment period. Additional sessions may be conducted if participants require further relief of withdrawal symptoms. All assessments and permitted concomitant treatments will be administered in accordance with the study protocol.
Sham stimulation
"Control Group (Sham Stimulation, n=12):~Participants in this group will use a sham stimulation device that does not deliver active stimulation. The sham device will be applied under the same schedule and conditions-60 minutes (±10 minutes) per session, at least once daily and 7 times per week for 4 weeks. All assessments and permitted concomitant treatments will be identical to those in the active stimulation group."
RECRUITING
Kyungpook National University Hospital, Daegu
Collaborators (1)
C&R Research, Inc.
INDUSTRY
Nu Eyne Co., Ltd.
INDUSTRY