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Идёт набор NCT03984565

PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

Фаза II С лечением 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: Cannabidiol, Placebo.
Кому может быть актуально
Состояния в реестре: Chronic Pain. Базовые параметры: от 21 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

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.

Подробное описание

Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.

Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.

Вмешательства

  • Препарат Cannabidiol
    High-CBD, low-THC sublingual product formulated in palm oil
  • Препарат Placebo
    Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.

Первичные конечные точки

  • Change in pain ratings on a Numerical Rating Scale (NRS) [Срок оценки: 6 weeks]
Вторичные конечные точки (5)
  • Change in pain ratings on the Brief Pain Inventory (BPI) [Срок оценки: 6 weeks]
  • Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: 6 weeks]
  • Change in ratings on the Pain Distress Scale (PDS) [Срок оценки: 6 weeks]
  • Change in ratings on the Pain Disability Index (PDI) [Срок оценки: 6 weeks]
  • Change in Conventional Medication Use [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Subject has provided informed consent
  • Subject is 21 or older
  • Subject is fluent in English
  • Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.

Критерии исключения

  • Non-fluent English speakers
  • Estimated IQ < 75
  • A history of head injury or loss of consciousness greater than 5 minutes
  • Currently uses CBD products regularly
  • Female subjects 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)
  • Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study
  • 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: NCT03984565 · 2023P001774

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗