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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the symptoms that cause patients to seek treatment. Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve an open-label to double-blind, placebo-controlled trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; 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, and cognition.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study consists of two phases: an open-label phase followed by a double-blind, placebo-controlled, randomized trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol Treatment Arm<br>High-CBD sublingual product administered three times daily for 6 weeks | Drug: Cannabidiol<br>* High-CBD, low-THC sublingual product formulated in palm oil<br>* Other names: CBD;|
| Placebo Comparator: Placebo Treatment Arm<br>Placebo sublingual product administered three times daily for 6 weeks | Drug: Placebo<br>* Placebo sublingual product formulated in palm oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain ratings on a Numerical Rating Scale (NRS) | 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 indicate less pain. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain ratings on the Brief Pain Inventory (BPI) | 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. | 6 weeks | 
| Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) | 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. | 6 weeks | 
| Change in ratings on the Pain Distress Scale (PDS) | 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. | 6 weeks | 
| Change in ratings on the Pain Disability Index (PDI) | 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. | 6 weeks | 
| Change in Conventional Medication Use | Change in conventional medication use, including opioids, will be assessed and analyzed. Changes in dose and frequency of conventional medication use will be quantified. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol, Medical Cannabis, Industrial Hemp