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Discussing the Clinical Trial: Mechanisms of Cannabidiol in Persons With MS: The Role of Sleep and Pain Phenotype

One of the biggest challenges people with multiple sclerosis have is getting to sleep. Muscle spasticity, as well as general pain, tends to keep individuals with MS from resting, despite them also having high levels of fatigue. If you or someone you know is struggling with pain and sleep from MS, you may be searching for natural ways to relieve both things. For many people, medical cannabis and cannabidiol (CBD) have provided some measure of comfort. However, research has yet to decide whether CBD is truly helpful. That is why a recent clinical trial called “Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype,” is underway [1].

What does this clinical trial hope to prove? And what other studies reported on sleep and pain management with CBD, particularly for those with MS? Let’s find out. 

Reviewing The Clinical Study

Beginning in March 2022, the University of Michigan study known as “Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype” began. Briefly, a phenotype is a set of observable characteristics in a single entity or group that results from interaction with the environment. In other words, the study is designed to compare the effects of cannabidiol (CBD) to those of tetrahydrocannabinol (THC) in individuals with multiple sclerosis. Presently, there is little known about the interactions of CBD and THC (alone or together) on sleep, particularly in those with diseases like MS. 

The participants (an estimated 166 in total) will randomly receive one of the treatment options: cannabidiol (CBD) in the form of the FDA-approved drug Epidiolex, THC (in the form of Marinol or dronabinol), a combination of CBD and THC, or a placebo [2]. Individuals taking Epidiolex will have a 0.5 mL dose twice daily for 7 days then 1.0 mL twice daily for the duration of the treatment. Those receiving THC will be given 2.5 mg for 7 days then 5.0 mg following that. The combination of CBD and THC is the same as the individual doses of either one. 

The researchers hope to monitor several things over a timeline of 12 weeks per participant, including the change in sleep length, Walsh Spectral Entropy, rapid eye movement (REM), sleep rhythms, and sleep continuity. 

The end of the study will potentially be in 2026.

What Are The Hypothesized Outcomes?

Due to some speculations and previous studies, the researchers are hoping to find evidence to support the idea that sleep problems associated with multiple sclerosis may be alleviated with CBD or THC or a combination of the two. The hypothesized outcome is yes, there is some effect. However, there is presently not enough data to say whether the effect is significant or not. Hopefully, the conclusion of this study will provide some insight to how CBD and THC may influence those individuals with MS so that they may sleep better.

What is Currently Known About CBD and Sleep

CBD is often marketed as a soporific—or a sleep-aid—as is medical cannabis. Because of this, there has been an increase in research looking into the connection between cannabidiol and sleep. One such study from 2021 that was published in the journal Neurotherapeutics notes that CBD works as an antagonist to THC, which is known for having a stimulant effect on some people when taken in moderate doses [3]. The study went on to state that, upon reviewing other previous studies, despite the limited results and clinical trials, there is some evidence of cannabinoids in general assisting with sleep. Again, more evidence and long-term clinical trials are needed before anything can be said for certain.

An earlier study from 2019 looked at a small sample of 72 adults with concerns about anxiety and poor sleep [4]. Within the first month of taking CBD, anxiety scores decreased in 57 participants. Sleep scores improved for 48 patients, but those scores started to fluctuate after one month of use.

Presently, a clinical study looking at the use of oral CBD in people with insomnia is underway. The CBD being used is highly purified and derived from hemp. Perhaps when this clinical study completes, people will have more insight as to how CBD impacts sleep physiology. 

What is Currently Known About CBD and MS

To fill in any gaps in this clinical study discussion, let’s briefly review what is currently understood about cannabidiol and multiple sclerosis. Right now, as with most diseases and disorders, how CBD affects someone with MS is not well known. Furthermore, research on MS specifically has been limited and often focuses on the entourage effect, which is when THC and CBD work synergistically, supposedly amplifying the therapeutic potential. 

A survey-based study from 2020 titled, “Cannabinoid use among Americans with MS: Current trends and gaps in knowledge” looked at THC, CBD, and THC/CBD combinations to see which was most effective in dealing with MS symptoms [5]. The findings illuminated a couple of things. First, that most of the respondents began using THC and/or CBD for medicinal purposes, and a large percentage of the participants (40%) preferred products that were high in CBD and low in THC. Another 17.6% stated they preferred only CBD. 76.9% of the participants also responded that cannabis was either absolutely beneficial or had at least some positive benefit.

The same study went on to ask the participants about how beneficial their THC, CBD, or combination of THC and CBD was for their symptoms. Using a scale of 1-10, with 10 being the most beneficial, most respondents stated that cannabis helped with pain (score of 7), sleep concerns (8), spasticity (7), anxiety (8), fatigue (7), tremors (8), attention problems (8), memory impairment (8), and bladder problems (8).

Though limited in sample size, these promising results show that CBD may assist those with MS positively.

CBD, MS, and Sleep: Final Thoughts

Are CBD and THC the answer to sleep and pain problems in those with multiple sclerosis? Despite the limited amount of research currently done, clinical trials are underway that may shed some light on the effectiveness of CBD. If you or someone you know as MS, the results of past and future studies can help you decide whether to try CBD—and potentially help you get restful sleep. 

Sugar Bottom Hemp has a wide variety of high-quality CBD products that are as close to farm-to-table as you can get. Our hemp-derived CBD is tested and certified by a third-party lab and comes in many forms. Check out our products today or get in touch with us to learn more about our offerings.

 

Bibliography

  1. Braley, T. J. (2022, March 8). Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype. US National Library of Medicine Clinical Trials. https://clinicaltrials.gov/ct2/show/study/NCT05269628
  1. Office of the Commissioner. (2020b, July 31). FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare
  1. Kaul, M., Zee, P. C., & Sahni, A. S. (2021). Effects of Cannabinoids on Sleep and their Therapeutic Potential for Sleep Disorders. Neurotherapeutics, 18(1), 217–227. https://doi.org/10.1007/s13311-021-01013-w
  1. Shannon, S., Lewis, N., Lee, H., & Hughes, S. (2019b). Cannabidiol in Anxiety and Sleep: A Large Case Series. The Permanente Journal, 23(1). https://doi.org/10.7812/tpp/18-041
  2. 5. Braley, T. J., Whibley, D., Alschuler, K. N., Ehde, D. M., Chervin, R. D., Clauw, D. J., Williams, D., & Kratz, A. L. (2020). Cannabinoid use among Americans with MS: Current trends and gaps in knowledge. Multiple Sclerosis Journal – Experimental, Translational and Clinical, 6(3), 205521732095981. https://doi.org/10.1177/2055217320959816