Sublingual Cannabidiol for Chronic Pain
Märksõnad
Abstraktne
Kirjeldus
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 psychoactive constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has demonstrated significant medicinal properties for a variety of disorders. Currently, 33 states and the District of Columbia have enacted full medical marijuana (MMJ) programs, and 14 states allow limited access to CBD-containing products. MMJ products can vary drastically in their cannabinoid constituent quantities and ratios, ranging from high THC products with very little CBD, to 1:1 ratios of THC to CBD, to high CBD products with very little THC. Although a wide range of products exist and are being actively used by consumers with a variety of medical indications, little is known about the direct impact of certain cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.
Chronic pain is one of the most common indications for MMJ use, and several studies have yielded compelling data suggesting that MMJ and its constituents may have analgesic and anti-inflammatory properties, suggesting that particular cannabinoids may have the potential to treat chronic pain. To date, no clinical trials have been conducted assessing the effects of a high-CBD, low-THC product for chronic pain. This investigation will involve a an open-label to double-blind, placebo-controlled trial of a high-CBD sublingual product; patients will be assessed at baseline and over 6 weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, cognition, and brain imaging (as appropriate).
Kuupäevad
Viimati kinnitatud: | 01/31/2020 |
Esmalt esitatud: | 06/06/2019 |
Hinnanguline registreerumine on esitatud: | 06/09/2019 |
Esmalt postitatud: | 06/12/2019 |
Viimane värskendus on esitatud: | 02/24/2020 |
Viimati värskendus postitatud: | 02/26/2020 |
Õppe tegelik alguskuupäev: | 07/31/2020 |
Eeldatav esmane lõpetamise kuupäev: | 08/30/2022 |
Eeldatav uuringu lõpetamise kuupäev: | 08/30/2022 |
Seisund või haigus
Sekkumine / ravi
Drug: Cannabidiol Treatment Arm
Drug: Placebo Treatment Arm
Faas
Käerühmad
Arm | Sekkumine / ravi |
---|---|
Experimental: Cannabidiol Treatment Arm 20mg/ml CBD sublingual product administered twice daily for 6 weeks | Drug: Cannabidiol Treatment Arm Cannabidiol sublingual product formulated in coconut oil |
Placebo Comparator: Placebo Treatment Arm Placebo sublingual product administered twice daily for 6 weeks | Drug: Placebo Treatment Arm Placebo sublingual product formulated in coconut oil |
Abikõlblikkuse kriteeriumid
Õppimiseks sobivad vanused | 21 Years To 21 Years |
Uuringuks kõlblikud sood | All |
Võtab vastu tervislikke vabatahtlikke | Jah |
Kriteeriumid | Inclusion Criteria: - Subject has provided informed consent - Subject is 21 or older - Subject is a native English speaker or acquired English prior to age 5 - 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-native English speakers - Estimated IQ < 75 - A history of head injury or loss of consciousness greater than 5 minutes - Currently uses marijuana 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 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 - Coconut allergy, as the product is formulated in coconut oil |
Tulemus
Esmased tulemusnäitajad
1. Change in pain ratings on the Brief Pain Inventory (BPI) [6 weeks]
Sekundaarsed tulemusmõõdud
1. Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [6 weeks]
2. Change in pain ratings on the Numerical Rating Scale (NRS) [6 weeks]
3. Change in ratings on the Pain Distress Scale (PDS) [6 weeks]
4. Change in ratings on the Pain Disability Index (PDI) [6 weeks]