ADTPM 1 auricular neurostimulation for opioid withdrawal symptoms

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

This trial will test whether daily ear (auricular) neurostimulation with the ADTPM 1 device helps adults experiencing opioid withdrawal.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: Nu Eyne Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Daegu, Daegu)
• Trial ID: NCT07079215 on ClinicalTrials.gov

What this trial studies

This single-center, double-blind, randomized, sham-controlled, parallel-design trial will enroll adults with opioid use disorder and clinically significant withdrawal to receive either active or sham auricular stimulation. Participants will receive daily 60-minute sessions with the ADTPM 1 device for four weeks. The primary outcome is the incidence of treatment-emergent adverse events, and secondary outcomes track changes in withdrawal severity, craving, pain, heart rate, depressive and anxiety symptoms, insomnia, somatic symptoms, and DSM-5 OUD criteria over time. The study is exploratory, designed to characterize safety signals and provide preliminary efficacy data versus sham.

Who should consider this trial

Good fit: Adults aged 19–80 who meet DSM-5 criteria for opioid use disorder, have a COWS score of 5 or higher, an NRS pain score below 6, and are not on long-acting opioid therapy are ideal candidates.

Not a fit: Patients with uncontrolled or clinically significant medical conditions, a history of seizures or neurological injury, or those on methadone or continuous long-acting opioids are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the device could provide a non-drug option that reduces opioid withdrawal symptoms and craving.

How similar studies have performed: Small studies and case series of auricular neurostimulation devices have shown promising but limited results, so the approach is partially supported but not yet widely proven.

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

Where this trial is running

Daegu, Daegu

• Kyungpook National University Hospital — Daegu, Daegu, South Korea (Recruiting)

Study contacts

• Study coordinator: Youngmin Park, Ph.D.

Conditions Opioid Withdrawal; Opioid Use Disorder; OUD