NCT07079215 Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
| NCT ID | NCT07079215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nu Eyne Co., Ltd. |
| Condition | Opioid Withdrawal (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-05-30 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
Eligibility Criteria
Inclusion Criteria: 1. Participants aged 19 to 80 years 2. Participants currently dependent on opioids, whether prescribed or non-prescribed 3. Participants who meet the criteria for opioid use disorder (OUD) according to DSM-5 4. Participants with a Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher 5. Participants with a Numeric Rating Scale (NRS) pain score of less than 6 6. Participants who have voluntarily decided to participate in the study and have provided written informed consent 7. Participants who are willing to comply with the study protocol Exclusion Criteria: 1. Participants with any current uncontrolled or clinically significant medical condition 2. Participants with a history of seizures or epilepsy 3. Participants with a history of neurological disorders or traumatic brain injury 4. Participants who have used long-acting opioids, such as methadone or buprenorphine, continuously for more than 5 days prior to screening 5. Participants who have used methadone within 30 days prior to screening 6. Participants who have used buprenorphine within 7 days prior to screening 7. Participants with physiological dependence on alcohol or drugs other than opioids, tobacco, or marijuana 8. Participants diagnosed with a major psychiatric disorder (psychosis, schizophrenia, or bipolar disorder) 9. Participants who are currently hospitalized due to a recent suicide attempt or who are persistently expressing suicidal intent 10. Participants with implanted devices such as a pacemaker, cochlear implant, or neurostimulator. 11. Participants with abnormal ear anatomy or ear infections 12. Participants diagnosed with renal or hepatic failure 13. Participants who are currently undergoing chemotherapy (Exception: Participation may be allowed if the investigator determines that participation poses no medical safety concerns for the participant) 14. Participants who are currently engaged in high-risk occupations (e.g., transportation workers, crane operators, heavy machinery operators, individuals working with sharp objects, or those requiring a high level of cognitive functioning) 15. Participants with implanted metal or electronic devices in the head or neck area, including deep brain stimulators or pacemakers, as specified in the product precautions and contraindications (dental implants are exempt) 16. Participants with cognitive impairment due to neurodevelopmental disorders (e.g., intellectual disability, developmental disorders, autism spectrum disorder) or neurodegenerative disorders (e.g., Alzheimer's disease, vascular dementia) that would make it difficult to undergo treatment with the investigational medical device 17. Participants who are pregnant or breastfeeding 18. Female participants of childbearing potential who do not agree to abstain from sexual intercourse or to use medically accepted contraception\* during the study period. \*Medically accepted methods of contraception include: condoms, consistent oral contraceptive use (≥3 months use), injectables or implantable contraceptives, or intrauterine devices (IUDs). 19. Participants who are currently participating in another clinical trial or who have participated in another clinical trial within 30 days prior to screening 20. Participants who, in the opinion of the investigator, are deemed inappropriate for participation due to ethical concerns or potential impacts on study outcomes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07079215 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Opioid Withdrawal (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07079215 currently recruiting?
Yes, NCT07079215 is actively recruiting participants. Contact the research team at youngmin.park@nueyne.com for enrollment information.
Where is the NCT07079215 trial being conducted?
This trial is being conducted at Daegu, South Korea.
Who is sponsoring the NCT07079215 clinical trial?
NCT07079215 is sponsored by Nu Eyne Co., Ltd.. The trial plans to enroll 24 participants.