Mechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain Phenotype
Tiffany J. Braley, MD, MS
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with clinically definite MS (those who are on a disease modifying therapy must be on a stable dose without evidence of liver toxicity for at least 3 months); 2. Presence of chronic pain defined as moderate to severe pain for at least 3 months, based on a 0-10 numeric rating scale (NRS); 3. Willingness to maintain stable analgesic regimen during study period; 4. Recent serum aspartate transaminase, alanine transaminase, and bilirubin testing within 90 days of screening; Exclusion Criteria: 1. Current shift work sleep disorder, or narcolepsy diagnosed with poly…
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®.
Location
- University of MichiganAnn Arbor, Michigan