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

NCT07079215 | Recruiting

• 1 other identifier: NE_ADT_001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Withdrawal (Disorder); Opioid Use Disorder

Keywords

OUD

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  The primary outcome is the incidence and severity of treatment-emergent adverse events (TEAEs) occurring from the first device application through the end of the 4-week treatment period. TEAEs include, but are not limited to, mild adverse events such as dizziness, somnolence, skin irritation, and headache. Safety will be assessed by monitoring vital signs, conducting physical examinations, and recording adverse events throughout the study period.

  [Time Frame: Baseline to Week 4]

Secondary Outcomes (11)

• Change in Clinical Opiate Withdrawal Scale (COWS) Scores

  [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]

• Change in Subjective Opiate Withdrawal Scale (SOWS) Scores

  [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]

• Change in Opioid Craving Visual Analogue Scale (OC-VAS)

  [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]

• Change in Heart Rate

  [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]

• Change in Numerical Rating Scale (NRS)

  [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group (Active Stimulation, n=12): 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: Neurostimulation

Control Group

SHAM COMPARATOR

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.

Device: Sham stimulation

Interventions

Neurostimulation DEVICE

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.

Also known as: ADTPM 1

Experimental Group

Sham stimulation DEVICE

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.

Control Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead
• C&R Research, Inc.: collaborator

Study Sites (1)

Kyungpook National University Hospital

Daegu, Daegu, 41944, South Korea

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Youngmin Park, Ph.D.

CONTACT

+821071177614; youngmin.park@nueyne.com

Eunmi Choi, M.S.

CONTACT

+821082418099; eunmi.choi@nueyne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: May 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 6, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

KR (1)