RecruitingPhase 2NCT05269628

Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype

Mechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain Phenotype


Sponsor

Tiffany J. Braley, MD, MS

Enrollment

166 participants

Start Date

Mar 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to compare the effects of cannabidiol (CBD), tetrahydrocannabinol (THC), or both, on sleep and pain in persons with multiple sclerosis (MS). Little is known about how CBD and/or THC may help sleep, reduce pain, or perhaps even treat pain through better sleep.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how CBD (cannabidiol) might help with chronic pain in people with multiple sclerosis (MS), and whether sleep quality plays a role in how well it works. **You may be eligible if...** - You have a confirmed diagnosis of MS - You have had moderate to severe chronic pain for at least 3 months - You are willing to keep your pain medication the same during the study - Your liver function tests are available from within the past 90 days - If on a disease-modifying therapy for MS, your dose has been stable for at least 3 months **You may NOT be eligible if...** - You currently use cannabis or CBD products (a 30-day stop period may allow eligibility) - You have had an MS relapse in the last 30 days - Your pain is caused by cancer - You are pregnant or breastfeeding - You have narcolepsy or shift work sleep disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCannabidiol (CBD)

Epidiolex® dose will be 0.5 mL (50 mg) twice daily during the first seven days of active treatment (half of full anticipated dose), followed by 1 mL (100 mg) twice daily for the remainder of the treatment interval (full dose). If the full dose (100 mg twice daily) is not tolerated by participants, they will have the option of going down to the original half-dose (50 mg twice daily). Participants who go back to the half-dose of Cannabidiol (50 mg twice daily) also have the option to request once-per-day dosing with study drug taken at preferred time of day. Participants who request once-per-day dosing will not exceed a total daily dose 100 mg Cannabidiol per day. Participants who are tolerating the full-dose of medication (Cannabidiol 100 mg twice daily) will not be allowed to combine these doses into one daily dose.

DRUGTetrahydrocannabinol (THC)

Dronabinol dose will be 2.5 mg twice daily during the first seven days of active treatment (half of full anticipated dose), followed by 5 mg twice daily for the remainder of the treatment interval (full dose). If the full dose (5 mg twice daily) is not tolerated by participants, they will have the option of going down to the original half-dose (2.5 mg twice daily). Participants who go back to the half-dose of Dronabinol (2.5 mg twice daily) also have the option to request once-per-day dosing with study drug taken at preferred time of day. Participants who request once-per-day dosing will not exceed a total daily dose 5 mg Dronabinol per day. Participants who are tolerating the full-dose of medication (Dronabinol 5 mg BID) will not be allowed to combine these doses into one daily dose.

DRUGPlacebo CBD

Placebo solution will be taken twice per day, using the same dosing regimen as described for Epidiolex®.

DRUGPlacebo THC

Placebo capsules will be taken twice per day in the same schedule and manner as active dronabinol.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT05269628


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