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Идёт набор NCT07281261

tAN for Substance Use Disorder

Без фазы С лечением Alcohol Use Disorder Alcohol Abuse Substance Use Disorders Substance Use Disorders Alcohol Use Withdrawal State

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: Sparrow Ascent, Sparrow Ascent (Sham).
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State. Базовые параметры: 18 лет — 64 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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Официальное название

Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder

Обзор

The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.

Вмешательства

  • Устройство Sparrow Ascent
    The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece.
  • Устройство Sparrow Ascent (Sham)
    Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.

Первичные конечные точки

  • Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) [Срок оценки: Every 4 hours during the tAN treatment (Days 2-6)]
  • Average benzodiazepine use [Срок оценки: Every 4 hours during the tAN treatment (Days 2-6)]
Вторичные конечные точки (3)
  • Penn Alcohol Craving Scale (PACS) [Срок оценки: Before Day 2 and after tAN treatment on Day 6]
  • Montgomery-Asberg Depression Scale (MADRS) [Срок оценки: Before Day 2 and after tAN treatment on Day 6]
  • Suicidal Behaviors Questionnaire-Revised (SBQ-R) [Срок оценки: Before Day 2 and after tAN treatment on Day 6]

Критерии участия

Критерии включения

  • Male or female (evenly recruited) aged 18-64 years old
  • Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
  • Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
  • Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \[PAWSS\] > 4 at admission)
  • Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \[CIWA-Ar\] ≥ 8 at screening)
  • Positive urine test for alcohol at screening
  • Be able to provide written informed consent
  • Female subjects must be non-nursing and not pregnant
  • Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.

Критерии исключения

  • In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
  • Current use of tobacco
  • Is pregnant or nursing
  • Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
  • Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The Menninger Clinic — Houston

Идентификаторы

NCT: NCT07281261 · SBM-AUD-01 · H-56001 · R41AA032157

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗