Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
All Genders
NCT07079215

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

Led by Nu Eyne Co., Ltd. · Updated on 2025-07-22

24

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

N

Nu Eyne Co., Ltd.

Lead Sponsor

C

C&R Research, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 19 and 80 years
  • Currently dependent on opioids, prescribed or non-prescribed
  • Diagnosed with opioid use disorder according to DSM-5
  • Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher
  • Numeric Rating Scale (NRS) pain score less than 6
  • Voluntarily agreed to participate and provided written informed consent
  • Willing to follow the study protocol
Not Eligible

You will not qualify if you...

  • Presence of any uncontrolled or clinically significant medical condition
  • History of seizures or epilepsy
  • History of neurological disorders or traumatic brain injury
  • Use of long-acting opioids (methadone or buprenorphine) continuously for more than 5 days before screening
  • Use of methadone within 30 days before screening
  • Use of buprenorphine within 7 days before screening
  • Dependence on alcohol or drugs other than opioids, tobacco, or marijuana
  • Diagnosis of major psychiatric disorders such as psychosis, schizophrenia, or bipolar disorder
  • Current hospitalization due to recent suicide attempt or persistent suicidal intent
  • Presence of implanted devices like pacemaker, cochlear implant, or neurostimulator
  • Abnormal ear anatomy or ear infections
  • Diagnosis of renal or hepatic failure
  • Currently undergoing chemotherapy unless deemed safe by investigator
  • Employment in high-risk occupations requiring high cognitive function
  • Implanted metal or electronic devices in head or neck area (excluding dental implants)
  • Cognitive impairment from neurodevelopmental or neurodegenerative disorders
  • Pregnancy or breastfeeding
  • Female participants of childbearing potential not agreeing to use medically accepted contraception
  • Participation in another clinical trial within 30 days before screening
  • Any condition deemed inappropriate by investigator for ethical or outcome reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Kyungpook National University Hospital

Daegu, Daegu, South Korea, 41944

Actively Recruiting

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Research Team

Y

Youngmin Park, Ph.D.

CONTACT

E

Eunmi Choi, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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