PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product (NCT03984565) | Clinical Trial Compass
RecruitingPhase 2
PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
United States25 participantsStarted 2024-06-27
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
What they're measuring
1
Change in pain ratings on a Numerical Rating Scale (NRS)