Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

December 1, 2025

Study Completion Date

April 6, 2026

Conditions
Opioid Withdrawal (Disorder)Opioid Use Disorder
Interventions
DEVICE

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.

DEVICE

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."

Trial Locations (1)

41944

RECRUITING

Kyungpook National University Hospital, Daegu

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

C&R Research, Inc.

INDUSTRY

lead

Nu Eyne Co., Ltd.

INDUSTRY

NCT07079215 - Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms | Biotech Hunter | Biotech Hunter