PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
Staci Gruber, Ph.D.
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.
Description
Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on th…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 bec…
Interventions
- DrugCannabidiol
High-CBD, low-THC sublingual product formulated in palm oil
- DrugPlacebo
Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.
Location
- McLean HospitalBelmont, Massachusetts