Health TrialsbyHealthPanel

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

ConditionsOpioid Withdrawal (Disorder)Opioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorNu Eyne Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

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
[Time Frame: Baseline to Week 4]

Secondary outcomes

1

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.

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

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.

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

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.

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nu Eyne Co., Ltd.

Lead sponsor

C&R Research, Inc.

Collaborator

Source ClinicalTrials.gov
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