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

2023P001774

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product for 6 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, and cognition.

2024-04-01

2025-09-01

2025-09-01

Not yet recruiting

Early phase I

56

Inclusion Criteria: * Subject has provided informed consent * Subject is 21 or older * Subject is fluent in English * Subject endorses a chronic pain condition including, but not limited to, chronic pain due to injury, musculoskeletal pain, arthritis (including osteoarthritis and rheumatoid arthritis), fibromyalgia, bursitis, endometriosis, 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 cannabis or CBD products * 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) * Neuropathic pain or cancer-related pain * Disclosure of a genetic polymorphism affecting CYP2C9 function

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study consists of two phases: an open-label phase followed by a double-blind, placebo-controlled, randomized trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

2024-03-08