Sublingual Cannabidiol for Chronic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study consists of two phases: an open-label phase followed by a double-blind, placebo-controlled, randomized trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 psychoactive constituent, and cannabidiol (CBD), the major non-intoxicating constituent that ha...
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).
Tracking Information
- NCT #
- NCT03984565
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Staci Gruber, Ph.D. Mclean Hospital
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