Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain. (CBD001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05002114|
Recruitment Status : Withdrawn (there were issues with the primary study material that prohibited continuation at this time)
First Posted : August 12, 2021
Last Update Posted : July 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Joint Pain||Drug: Cannabidiol Other: Placebo||Phase 1|
Introduction and Rationale
Currently, the opioid epidemic is a public health crisis. Use of opioids for chronic pain are a large component of this crisis. If alternative means can be developed to treat chronic pain that can replace the use of opioid-based treatments, this can improve clinical outcomes and quality of life.
Arthritis and musculoskeletal pain are often chronic conditions that cause significant morbidity. Historically, one study estimated that the lifetime incidence is as high as 47% for osteoarthritis over the lifespan, increasing with age and also increasing to 60% with a body mass index over than 30. In our society today with over 50% of the population suffering from obesity, this is a significant problem.
While cannabis products have been referenced for treating numerous medical issues including a number of pain-related conditions, it has only been recently that mechanisms outside the central nervous system have been recognized. There is very little published in regards to the use of cannabidiol (CBD) in the treatment of arthritic pain, and even less on the topical application of CBD products in its use in this manner. Two previous studies demonstrated the efficacy of a local/transdermal application of CBD in rodent models of arthritis. Activity at the TRPV2 receptor is one possible mechanism for this putative mechanism. Another possible interaction is at the GPR55 receptor.
The earliest known references to the medicinal properties of cannabis can be found in the "Shennong Ben Cao Jing", which describe Chinese uses of herbal remedies from as early as 2700 BC. In later compilations of this work, cannabis is described as being utilized for the treatment of pain and inflammation. Since that time, cannabis has been used world-wide both medicinally and for recreational purposes. It has only been a recent development (within the past 100 years) that public health regulations have prohibited the use of cannabis products.
However, problems do exist with the use of CBD products. The FDA has issued numerous letters warning manufacturers of CBD products about false advertising and/or illegal marketing of CBD for unapproved uses to treat disorders such as Alzheimer's disease. In addition, prior evaluations of products containing CBD found that 69% were mislabeled in regards to the contents provided on the product labels. Given these matters, it is our intent to evaluate the efficacy of a topical CBD (TC) preparation in improving clinical outcomes in patients with chronic musculoskeletal joint pain. Specifically the investigators wish to establish the efficacy of TC, a product specifically formulated for topical application at pre-defined dosages.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double-blind, randomized, placebo-controlled.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double-blind, randomized, placebo-controlled.|
|Official Title:||Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.|
|Estimated Study Start Date :||January 2023|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Placebo Comparator: Placebo Group
Does not get active topical CBD. Instead, gets an identical placebo-containing topical agent.
Not the drug
Experimental: Active Group
Does get active topic CBD.
Topical CBD cream - special formulation
- Change in PGI-S [ Time Frame: Two time points, before treatment and after 4 weeks. ]Patient Global Impression of Severity Scale from 1 to 7 with higher scores indicating worse condition
- Change in PGI-C [ Time Frame: Two time points, before treatment and after 4 weeks. ]Patient Global Impression of Change Scale from 1 to 7 with higher scores indicating worse condition
- Change in QOLS [ Time Frame: Two time points, before treatment and after 4 weeks. ]Quality of Life Scale Scale from 16 to 112, with higher scores indicating better condition