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Идёт набор NCT06393101

The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome

Фаза I С лечением Complex Regional Pain Syndrome

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: BRC-002, BRC-002 Placebo.
Кому может быть актуально
Состояния в реестре: Complex Regional Pain Syndrome. Базовые параметры: 21 лет — 75 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, Double-blind, Placebo-controlled Study to Investigate the Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome

Обзор

The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities. The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.

Подробное описание

Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury.

The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.

The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.

Вмешательства

  • Препарат BRC-002
    BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (\<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids.
  • Препарат BRC-002 Placebo
    Oral solution of mono-, di-, and triglycerides

Первичные конечные точки

  • Change in complex regional pain syndrome pain and heat pain measured with VAS [Срок оценки: Day 1 - Day 42]
Вторичные конечные точки (4)
  • Pain Inventory Measure [Срок оценки: Day 1 - Day 42]
  • Depression Measure [Срок оценки: Day 1 - Day 42]
  • Sleep Measure [Срок оценки: Day 1 - Day 42]
  • Interleukin 6 [Срок оценки: Day 1 - Day 42]

Критерии участия

Критерии включения

  • Provision of signed and dated informed consent form.
  • Are between 21-75 years old
  • Ability to communicate in English
  • Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
  • Are not currently using any type of cannabis, including hemp or CBD
  • Currently 30 days cannabis free
  • Participants with ongoing CRPS \[Type 1 or Type 2)\] for at least 3 months prior to participation (medical record confirmed)
  • Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
  • Agrees not to use opioids or barbiturates during participation in the study

Критерии исключения

  • Fail cannabis screening
  • Active pulmonary disease
  • Allergy or past adverse effects or negative past experiences from cannabis
  • Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
  • Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
  • Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
  • Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury/head injury
  • Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
  • Any current or history of suicidal ideation or attempt
  • Patients with clinically significant laboratory abnormalities

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Altman Clinical and Translational Research Institute — La Jolla
  • University of California, San Diego — San Diego

Идентификаторы

NCT: NCT06393101 · 809767

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗