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Идёт набор NCT06487533

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

— Наблюдательное Opioid Withdrawal Opioid Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EmbracePlus Smartwatch, Corti Sensor.
Кому может быть актуально
Состояния в реестре: Opioid Withdrawal, Opioid Use Disorder. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

Подробное описание

This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.

Вмешательства

  • Устройство EmbracePlus Smartwatch
    The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data can be wirelessly transmitted to a paired mobile device. The data received are analyzed by EmpaDSP, which computes the user physiological parameters. The Care App is responsible for transmitting raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. The device supports continuous data collection for monitoring of the fo
  • Устройство Corti Sensor
    The Corti Wearable is a sweat sensor that is worn continuously measure cortisol, melatonin, tumor necrosis alpha interleukin-6 (IL-6) in the protein analytes in the sweat of participants via electrochemical impedance spectroscopy. The Corti Wearable comprises a plastic reader and a replaceable polymer sweat-sensing strip with zinc oxide (ZnO) coated electrodes that is worn on the participant's forearm. It is manufactured through a screen-printing technique that allows for an affinity-based inter

Первичные конечные точки

  • Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) [Срок оценки: Daily throughout the 14-day inpatient detoxification treatment]
  • Clinical Opioid Withdrawal Scale (COWS) [Срок оценки: Daily throughout the 14-day inpatient detoxification treatment]
  • Opioid Craving Visual Analog Scale (OC-VAS) [Срок оценки: Daily throughout the 14-day inpatient detoxification treatment]
  • Adverse Events [Срок оценки: Daily throughout the 14-day inpatient detoxification treatment]

Критерии участия

Критерии включения

  • Participant has a recent history of opioid dependence; prescription or non-prescription
  • Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
  • Participant is between 18 and 50 years of age
  • Participant is English proficient
  • Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
  • Participant is willing to wear wearable sensors for 14 days

Критерии исключения

  • Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
  • Participant has a history of epileptic seizures
  • Participant has a history of neurological diseases or traumatic brain injury
  • Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
  • Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
  • Females who are pregnant or lactating
  • Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • Hazelden Betty Ford Foundation — Center City
  • Battelle Memorial Institute — Columbus

Идентификаторы

NCT: NCT06487533 · SBM-OWP-09 · 1R43DA059448

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗