Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTiffany J. Braley, MD, MS
About this trial
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 criteria
Qualifiers
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);
Presence of chronic pain defined as moderate to severe pain for at least 3 months, based on a 0-10 numeric rating scale (NRS);
Willingness to maintain stable analgesic regimen during study period;
Recent serum aspartate transaminase, alanine transaminase, and bilirubin testing within 90 days of screening;
Disqualifiers
Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test;
History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window);
Pain due to cancer;
Pregnancy or breastfeeding;
Trial design
Treatments tested in this trial
- Cannabidiol (CBD)
- Tetrahydrocannabinol (THC)
- Placebo CBD
- Placebo THC
Treatment groups
166 Participants
are divided into 4 treatment groupsSponsors and collaborators
Tiffany J. Braley, MD, MS
Lead sponsor
University of Michigan
Sponsor institution
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov