Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07079215
NA

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

Sponsor: Nu Eyne Co., Ltd.

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.

Official title: A Single Center, Double-Blind, Randomized, Sham-Controlled, Parallel Design, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of a Medical Device for the Treatment of Opioid Withdrawal Symptoms

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-05-30

Completion Date

2026-04-06

Last Updated

2025-07-22

Healthy Volunteers

No

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.

Locations (1)

Kyungpook National University Hospital

Daegu, Daegu, South Korea