Opioid Withdrawal (Disorder)NCT07079215
Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
A study testing Neurostimulation in people with Opioid Withdrawal (Disorder) and Opioid Use Disorder, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- What is being tested?
- Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2025to 6 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, Daegu, 41944
Hyemi Yang, +82532005430, knuhirb@knu.kr
Hoyeon Kang, +82532005431, knuhirb@knu.kr
About this study
Official title: 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 study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
Read the detailed description
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.
- Conditions
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- Being tested
- Neurostimulation, Sham stimulation
- Keywords
- OUD
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationDevice
Also called ADTPM 1
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.
Sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Baseline to Week 4]
Secondary outcomes (11)
Change in Clinical Opiate Withdrawal Scale (COWS) Scores
Change from baseline in COWS scores to assess the severity of opioid withdrawal symptoms over time. Higher scores indicate more severe withdrawal symptoms.
Measured: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Subjective Opiate Withdrawal Scale (SOWS) Scores
Change from baseline in SOWS scores to evaluate patient-reported withdrawal symptoms. Higher scores indicate more severe withdrawal symptoms.
Measured: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Opioid Craving Visual Analogue Scale (OC-VAS)
Change in opioid craving levels measured by a visual analogue scale. Higher scores indicate more severe craving.
Measured: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Heart Rate
Change in resting heart rate from baseline to assess physiological responses related to withdrawal. Higher heart rate may reflect increased autonomic arousal associated with withdrawal.
Measured: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Numerical Rating Scale (NRS)
Change in self-reported pain severity measured by the NRS. Higher scores indicate greater pain intensity.
Measured: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
Change in depressive symptom severity from baseline. Higher scores indicate more severe depressive symptoms.
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
Change in anxiety symptom severity from baseline. Higher scores indicate more severe anxiety symptoms.
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Insomnia Severity Index-Korean (ISI-K) Scores
Change in insomnia symptoms assessed by ISI-K. Higher scores indicate more severe insomnia symptoms.
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Patient Health Questionnaire-15 (PHQ-15) Scores
Change in somatic symptom severity over the treatment period. Higher scores indicate more severe somatic symptoms.
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in DSM-5 Criteria for Opioid Use Disorder
Change in diagnostic status of opioid use disorder as defined by DSM-5. Meeting more criteria indicates greater disorder severity
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Opioid Craving Scale (OCS-3) Scores
Change in opioid craving symptoms measured by OCS-3. Higher scores indicate more severe craving.
Measured: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start30 May 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion6 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Withdrawal (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079215
- Sponsor's protocol ID
- NE_ADT_001
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07079215
- Acronym / sponsor ID
- NE_ADT_001
- Conditions
- Opioid Withdrawal (Disorder), Opioid Use Disorder
- Keywords
- OUD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc.
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 6 Apr 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: NeurostimulationExperimental 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. |
| Control Group | Sham comparator | Device: Sham stimulationControl 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurostimulationAlso: ADTPM 1Participants 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 | Experimental Group |
| Sham stimulationControl 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 | Control Group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: [Time Frame: Baseline to Week 4]
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.
11 secondary outcomes
Change in Clinical Opiate Withdrawal Scale (COWS) Scores
Time frame: [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: [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: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Heart Rate
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Numerical Rating Scale (NRS)
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Insomnia Severity Index-Korean (ISI-K) Scores
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Patient Health Questionnaire-15 (PHQ-15) Scores
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in DSM-5 Criteria for Opioid Use Disorder
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Opioid Craving Scale (OCS-3) Scores
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation in people with Opioid Withdrawal (Disorder) and Opioid Use Disorder, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngmin Park, Ph.D. (+821071177614, youngmin.park@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: [Time Frame: Baseline to Week 4]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.