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

Официальное название

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

Обзор

This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.

Подробное описание

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.

Вмешательства

• Устройство Neurostimulation
  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.
• Устройство Sham stimulation
  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.

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: [Time Frame: Baseline to Week 4]]

Вторичные конечные точки (11)

• Change in Clinical Opiate Withdrawal Scale (COWS) Scores [Срок оценки: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Subjective Opiate Withdrawal Scale (SOWS) Scores [Срок оценки: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Opioid Craving Visual Analogue Scale (OC-VAS) [Срок оценки: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Heart Rate [Срок оценки: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Numerical Rating Scale (NRS) [Срок оценки: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Generalized Anxiety Disorder-7 (GAD-7) Scores [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Insomnia Severity Index-Korean (ISI-K) Scores [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Patient Health Questionnaire-15 (PHQ-15) Scores [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in DSM-5 Criteria for Opioid Use Disorder [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]
• Change in Opioid Craving Scale (OCS-3) Scores [Срок оценки: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Kyungpook National University Hospital — Daegu

Идентификаторы

NCT: NCT07079215 · NE_ADT_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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