Идёт набор NCT06206252

Can Medical Cannabis Affect Opioid Use?

— Наблюдательное Chronic Pain 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: Medical Cannabis.
Кому может быть актуально: Состояния в реестре: Chronic Pain, Pain. Базовые параметры: от 18 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

The Effect of Medical Cannabis on Opioid Use for Individuals with Chronic Pain

Обзор

The goal of this observational study is to learn how medical cannabis (MC) affects pain and the use of opioid pain medications. Participants who have chronic pain and use prescribed opioid pain medication will opt-in to using MC or not for the 3-month study. Participants who are certified in Pennsylvania will purchase specific medical cannabis products at a reduced cost from a partnering medical cannabis dispensary monthly. All participants will complete baseline, daily, and monthly assessments to observe changes across groups.

Подробное описание

The primary aim is to observe if individuals who have chronic pain that they are treating with opioids and medical cannabis report changes in pain severity, function, and opioid use compared to those who do not use medical cannabis.

Secondary aims include observation of whether the use of medical cannabis differentially impacts tolerability (side effects, risk of cannabis use disorder), sleep-related symptoms, or quality of life and mental health among chronic opioid users.

There will be two groups, participants who are certified to use medical cannabis and those who do not use any cannabis. All participants will complete a baseline survey to report demographics, pain, sleep, mental health, well-being, quality of life, and use of medications. Some of these questions will be repeated monthly. Participants will also receive a link via text to a daily survey to report daily prescription opioid use and medical cannabis use (if applicable) as well as pain severity and interference.

Participants who purchase medical cannabis at Ethos will be randomized and restricted to one formulation of medical cannabis (vaporization or tincture) for the study duration. They will purchase three different compositions of the specific medical cannabis formulation at a reduced cost over 3 months and the order of those compositions will be randomized. They will purchase one composition per month and they will not know which one they are purchasing. The three different compositions are:

* A composition that is predominantly THC (tetrahydrocannabinol) * A composition that is predominantly CBD (Cannabidiol) * A composition that is a one-to-one blend of THC and CBD

Вмешательства

Другое Medical Cannabis
Participants will be restricted to specific medical cannabis products from Ethos Dispensary. They will be randomized to one medical cannabis formulation (tincture or vaporization) for the duration of the study. Each month for three months, they will purchase a different composition (predominantly THC, predominantly CBD, or balanced products) of their designated formulation. The order of compositions will be randomized and double-blinded, so participants and the research team will not know which

Первичные конечные точки

Change in pain severity [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]
Change in pain interference [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]
Change in pain [Срок оценки: Daily up to 12 weeks]
Change in daily use of prescription opioids [Срок оценки: Daily up to 12 weeks]

Вторичные конечные точки (4)

Change in quality of life [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]
Change in mental health status [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]
Change in sleep quality [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]
Side effects of medical cannabis [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks]

Критерии участия

Критерии включения

Current diagnosis of chronic, intractable pain
Use of prescription opioids for longer than 90 days
Have a smartphone or agree to use one provided
English fluency
Medical cannabis group only: Willing to get certified by a physician to use medical cannabis in PA OR already certified but have not been using medical cannabis products regularly (daily or weekly) for longer than 30 days
Medical cannabis group only: Willing to accept a temporary restriction on medical cannabis products
Control group: Agree to continue not using cannabis for the duration of the study (3 months)