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

This study is a single-center, double-blind, randomized, sham-controlled, parallel-design exploratory clinical trial to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) in adults with opioid withdrawal symptoms. Eligible participants will be randomized to receive either active stimulation or sham stimulation applied to the auricular region daily for 60 minutes over a 4-week period. The primary objective is to assess the incidence of treatment-emergent adverse events. Secondary objectives include evaluating changes in opioid withdrawal severity, craving, pain, heart rate, depressive symptoms, anxiety, insomnia, somatic symptoms, and DSM-5 criteria for opioid use disorder over time.

Inclusion criteria

• Participants aged 19 to 80 years
• Participants currently dependent on opioids, whether prescribed or non-prescribed
• Participants who meet the criteria for opioid use disorder (OUD) according to DSM-5
• Participants with a Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher
• Participants with a Numeric Rating Scale (NRS) pain score of less than 6
• Participants who have voluntarily decided to participate in the study and have provided written informed consent
• Participants who are willing to comply with the study protocol

Exclusion criteria

• Participants with any current uncontrolled or clinically significant medical condition
• Participants with a history of seizures or epilepsy
• Participants with a history of neurological disorders or traumatic brain injury
• Participants who have used long-acting opioids, such as methadone or buprenorphine, continuously for more than 5 days prior to screening
• Participants who have used methadone within 30 days prior to screening
• Participants who have used buprenorphine within 7 days prior to screening
• Participants with physiological dependence on alcohol or drugs other than opioids, tobacco, or marijuana
• Participants diagnosed with a major psychiatric disorder (psychosis, schizophrenia, or bipolar disorder)
• Participants who are currently hospitalized due to a recent suicide attempt or who are persistently expressing suicidal intent
• Participants with implanted devices such as a pacemaker, cochlear implant, or neurostimulator.
• Participants with abnormal ear anatomy or ear infections
• Participants diagnosed with renal or hepatic failure
• 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)
• 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)
• 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)
• 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
• Participants who are pregnant or breastfeeding
• 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).

• Participants who are currently participating in another clinical trial or who have participated in another clinical trial within 30 days prior to screening
• Participants who, in the opinion of the investigator, are deemed inappropriate for participation due to ethical concerns or potential impacts on study outcomes