We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (there were issues with the primary study material that prohibited continuation at this time)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
Sponsor:
Information provided by (Responsible Party):
James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport

Brief Summary:
Double-blind, randomized into two arms (TC and TP): patients get either topical cannabidiol or topical placebo up to three times daily. Inclusion criteria will be chronic joint pain with intent to treat or currently treated with opioids. Exclusion criteria will include current cannabis use, severe medical illness or lacking in capacity to be involved in study. TC and TP will be prescribed for use TID in predefined dosages and quantities.

Condition or disease Intervention/treatment Phase
Musculoskeletal Joint Pain Drug: Cannabidiol Other: Placebo Phase 1

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Does not get active topical CBD. Instead, gets an identical placebo-containing topical agent.
Other: Placebo
Not the drug

Experimental: Active Group
Does get active topic CBD.
Drug: Cannabidiol
Topical CBD cream - special formulation




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Diagnosis of chronic musculoskeletal joint pain (arthritis, traumatic arthritis, osteoarthritis)
  2. Adults ages 18 and over.
  3. Medically stable without significant medical illness that would preclude treatment with either pharmacologic agent.
  4. Have a safe, stable, living environment.

Exclusion Criteria

  1. Unable to consent for research project.
  2. Individuals less than 18 years of age.
  3. Individuals with rheumatoid or other autoimmune types of arthritis.
  4. Individuals diagnosed with SUD especially cannabis, as this may confound results.
Layout table for additonal information
Responsible Party: James C. Patterson, II, MD. Ph, Clinical Director, Louisiana Addiction Research Center, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT05002114    
Other Study ID Numbers: IND_CBD_001
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Cannabidiol
Anticonvulsants