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Clinical Trial: Cannabidiol In People With MS: The Role Of Sleep And Pain (Cansleep-MS)

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Details
Type of MS: PPMS|PRMS|RRMS|SPMS
Treatment mode of action: To improve symptoms
Number of Subjects: 165
Medication: Cannabidiol (CBD), Tetrahydrocannabinol (THC), or Placebo
Location: Michigan
Institutions: University of Michigan
1500 East Medical Center Drive
Ann Arbor, MI 48109 Contact Information
Shay Robison
734.936.2844
roshay@med.umich.edu

Funding:

The National Center for Complementary and Integrative Health (NCCIH)

Description

Cannabidiol, the active ingredient in Epidiolex®, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant.  Clinical trials suggest that cannabinoids (active compounds in Cannabis sativa) can be effective analgesics in individuals with chronic pain.

Researchers in the Departments of Physical Medicine & Rehabilitation (PM&R) and Neurology are studying several pain treatments in adults with Multiple Sclerosis (MS) who have chronic pain. Dr. Anna Kratz, a psychologist and researcher in the PM&R Department, and Dr. Tiffany Braley, a neurologist and MS specialist within the Neurology Department, are working together on this study to evaluate treatments for pain in MS and impact on sleep quality. We are currently enrolling adults with MS and bothersome pain in our study with a pain score of at least 4 out of 10 (with 0 being no pain and 10 being severe pain). Participants in this study will be provided with a treatment for MS pain for 12 weeks, at no cost. Throughout the trial, participants will be given several short surveys (online or in-person), to assess their pain, sleep, and other symptoms. Before and at the end of the treatment, participants will wear a wrist-worn activity monitor for 14 days to measure symptoms, as well as sleep and physical activity.

Study visits take place in Ann Arbor, MI and include four planned visits including an overnight sleep study before begining treatment and near the end of treatment. A blood sample (about 1 teaspoon) will be taken before treatment, mid-treatment and at the end of therapy.
 
Participants will be compensated throughout the course of the study. If you are interested in this study, please contact the study team at https://umhealthresearch.org/#studies/HUM00190734 to learn more or cansleep@med.umich.edu

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