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Идёт набор NCT04379115

Optimization of NIBS for Treatment of Addiction

Без фазы С лечением Opioid-use Disorder Chronic Pain

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: Active Comparator: Active tDCS + Active TUS, Sham Comparator: Sham tDCS + Sham TUS.
Кому может быть актуально
Состояния в реестре: Opioid-use Disorder, Chronic Pain. Базовые параметры: 18 лет — 85 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
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Официальное название

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Обзор

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Вмешательства

  • Устройство Active Comparator: Active tDCS + Active TUS
    Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.
  • Устройство Sham Comparator: Sham tDCS + Sham TUS
    Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

Первичные конечные точки

  • Change in drug use from baseline. [Срок оценки: Measured for approximately 6 weeks]
Вторичные конечные точки (12)
  • Changes in the Verbal Rating Scale (VRS) for Pain [Срок оценки: Measured for approximately 6 weeks]
  • Changes in pain as measured by the Visual Analog Scale (VAS) [Срок оценки: Measured for approximately 6 weeks]
  • Safety measures [Срок оценки: Measured for approximately 6 weeks]
  • Study 36-Item Short Form (SF-36) [Срок оценки: Measured for approximately 6 weeks]
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: Measured for approximately 6 weeks]
  • Electroencephalography (EEG) recording: [Срок оценки: Measured for approximately 6 weeks]
  • Ultimatum Game: [Срок оценки: Measured for approximately 6 weeks]
  • Risk Task: [Срок оценки: Measured for approximately 6 weeks]
  • Inhibitory Control Task: [Срок оценки: Measured for approximately 6 weeks]
  • Opioid Cue-Exposure Task for Craving Assessment: [Срок оценки: Measured for approximately 6 weeks]
  • Hair follicle drug test [Срок оценки: Measured for approximately 6 weeks]
  • National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) [Срок оценки: Measured for approximately 6 weeks]

Критерии участия

Критерии включения

Participants must meet all of the following:

  • Provide informed consent
  • Age 18-85 years
  • Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology
  • Report current opioid craving
  • Enrolled in a certified Opioid Treatment Program and receiving methadone maintenance treatment
  • Stable methadone dose prior to enrollment
  • Reside locally with no plans to relocate during the study Exclusion Criteria

Participants will be excluded if they:

  • Are pregnant
  • Have frequent illicit stimulant use or acute stimulant intoxication
  • Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)
  • Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head injury, or unexplained syncope
  • Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)
  • Have moderate to severe depression or active suicidal ideation/behavior
  • Have active malignancy
  • Consume substances that could confound opioid toxicology results (e.g., poppy-seed products)

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • University of Illinois Health/ University of Illinois at Chicago — Hinsdale
  • Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center — Cambridge
  • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit — Cleveland

Идентификаторы

NCT: NCT04379115 · STUDY20190760

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗