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Идёт набор NCT06218706

LIFU for Treatment for Refractory Opioid Use Disorder

Без фазы С лечением 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: Low Intensity Focussed Ultrasound.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: 22 лет — 60 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

A Randomized, Sham-Controlled Trial Investigating Low Intensity Focused Ultrasound as a Novel Treatment for Refractory Opioid Use Disorder

Обзор

This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.

Подробное описание

The overall objective of this study is to assess the safety, tolerability, and feasibility of using Low Intensity Focused Ultrasound (LIFU) to treat opioid use disorder (OUD) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.

Вмешательства

  • Устройство Low Intensity Focussed Ultrasound
    The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

Первичные конечные точки

  • Occurrence of Treatment Emergent Adverse Events [Срок оценки: Post-ExAblate Procedure through 90 day Follow-Up]
  • Changes in Opioid Use [Срок оценки: Post-ExAblate Procedure through 90 day Follow-Up]

Критерии участия

Критерии включения

  • Aged 22 - 60 years at time of enrollment.
  • Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history.
  • Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.

Критерии исключения

  • Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours.
  • History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
  • History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC).
  • Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS).
  • Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
  • More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
  • Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
  • Subject with impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
  • Hepatic function laboratory values which are > 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator.
  • Past or present diagnosis of schizophrenia or psychotic disorder.
  • Subject unwilling to attempt abstinence from illicit substance use during the course of the study.
  • Unable to speak, read and understand English.
  • Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • WVU Rockefeller Neuroscience Institute — Morgantown

Идентификаторы

NCT: NCT06218706 · 2312890071

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗