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Идёт набор NCT06477406

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Фаза II С лечением Endometriosis

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: Cannabidiol, Placebo.
Кому может быть актуально
Состояния в реестре: Endometriosis. Базовые параметры: от 21 лет · Женщины.
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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Обзор

Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.

Подробное описание

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.

This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.

Вмешательства

  • Препарат Cannabidiol
    Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.
  • Препарат Placebo
    An active placebo containing supplemental terpenes matched to the high-CBD product.

Первичные конечные точки

  • Visual Analog Scale (VAS) [Срок оценки: 12 weeks]
Вторичные конечные точки (7)
  • Endometriosis Health Profile (EHP-30) [Срок оценки: 12 weeks]
  • VAS-IBS [Срок оценки: 12 weeks]
  • Beck Anxiety Inventory (BAI) [Срок оценки: 12 weeks]
  • Beck Depression Inventory (BDI) [Срок оценки: 12 weeks]
  • Conventional Medication Use [Срок оценки: 12 weeks]
  • Inflammatory Biomarkers [Срок оценки: 12 weeks]
  • Circulating Endocannabinoid Concentrations [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Subject has provided informed consent
  • Sex assigned female at birth
  • Subject is 21 or older
  • Subject is fluent in English
  • Subject endorses at least moderate levels of pain at the baseline visit
  • Subject endorses having endometriosis

Критерии исключения

  • Non-fluent English speakers
  • Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
  • Currently uses cannabis or cannabinoid products regularly
  • Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
  • Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
  • Neuropathic pain or cancer-related pain
  • Disclosure of a genetic polymorphism affecting CYP2C9 function

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • McLean Hospital — Belmont

Идентификаторы

NCT: NCT06477406 · 2024P001549

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗