Sublingual Cannabidiol for Chronic Pain
Study Details
Study Description
Brief Summary
This study involves taking a high-cannabidiol (CBD) sublingual product for 6 weeks in order to assess the impact of CBD on chronic pain, conventional medication use, clinical state, quality of life, cognition, and where applicable, brain structure and function via neuroimaging.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cannabidiol Treatment Arm 20mg/ml CBD sublingual product administered twice daily for 6 weeks |
Drug: Cannabidiol
Cannabidiol sublingual product formulated in coconut oil
Other Names:
|
| Placebo Comparator: Placebo Treatment Arm Placebo sublingual product administered twice daily for 6 weeks |
Drug: Placebo
Placebo sublingual product formulated in coconut oil
|
Outcome Measures
Primary Outcome Measures
- Change in pain ratings on the Brief Pain Inventory (BPI) [6 weeks]
The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.
Secondary Outcome Measures
- Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [6 weeks]
The PSEQ contains several questions assessing the patients' confidence in carrying out certain activities despite their pain on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). Higher scores are better.
- Change in pain ratings on the Numerical Rating Scale (NRS) [6 weeks]
The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores are better.
- Change in ratings on the Pain Distress Scale (PDS) [6 weeks]
The PDS is an 11-point scale one where subjects rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.
- Change in ratings on the Pain Disability Index (PDI) [6 weeks]
On the PDI, the subject rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". Lower scores are better.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has provided informed consent
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Subject is 21 or older
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Subject is a native English speaker or acquired English prior to age 5
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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:
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Non-native English speakers
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Estimated IQ < 75
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A history of head injury or loss of consciousness greater than 5 minutes
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Currently uses marijuana or CBD products
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Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
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Presence of a serious medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
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Neuropathic pain or cancer-related pain
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Disclosure of a genetic polymorphism affecting CYP2C9 function
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Coconut allergy, as the product is formulated in coconut oil
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Staci Gruber, Ph.D.
Investigators
- Principal Investigator: Staci Gruber, Ph.D., Mclean Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P001480