Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05269628

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

Led by Tiffany J. Braley, MD, MS · Updated on 2025-07-25

166

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

Sponsors

T

Tiffany J. Braley, MD, MS

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with clinically definite MS, stable on disease modifying therapy for at least 3 months without liver toxicity
  • Chronic moderate to severe pain for at least 3 months based on a 0-10 pain scale
  • Willingness to maintain a stable pain medication regimen during the study
  • Recent liver function tests (AST, ALT, bilirubin) within 90 days before screening
Not Eligible

You will not qualify if you...

  • Current shift work sleep disorder or narcolepsy diagnosed by sleep studies
  • MS relapse within 30 days before screening
  • Pain caused by cancer
  • Pregnancy or breastfeeding
  • Current cannabinoid use or unwillingness to abstain from cannabinoids 30 days before and during the study
  • Unwillingness to use contraception during the study
  • Current suicidal thoughts with intent or plan
  • Severe depression as indicated by PHQ-9 score 17 or higher
  • History of mania or schizophrenia
  • Known allergy to cannabinoids, Epidiolex, Dronabinol, or excipients
  • Recent heart attack, stroke, or severe heart conditions
  • Severe liver impairment
  • History of seizure disorder or certain head injuries
  • History of drug abuse
  • Risk for alcohol misuse
  • Current use of warfarin, valproate, or clobazam
  • Use of strong CYP3A4 inhibitors or inducers
  • Use of certain CYP2C9 or CYP2C19 affecting drugs
  • Refusal to avoid grapefruit products during the study
  • Current opioid use except tramadol
  • Employment involving commercial driving, extreme heights, or heavy machinery
  • History of car crashes or near-crashes due to untreated sleepiness in past 6 months
  • Cognitive dysfunction
  • Expanded Disability Status Scale score 8.0 or higher
  • Blood pressure outside specified safety range or history of syncope related to orthostatic hypotension
  • Resting heart rate below 50 or above 100 bpm
  • Other medical, neurological, sleep, or psychiatric conditions affecting safety or eligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

Loading map...

Research Team

D

David Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here