Pain Clinical Trial
Official title:
The Effect of Medical Cannabis on Opioid Use for Individuals With Chronic Pain
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.
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 ;
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