Open Actively Recruiting

Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

About

Brief Summary

The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Meet the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Classification Criteria for Rheumatoid Arthritis
  • Disease activity score (DAS28) >= 3.2
  • Age >= 18
  • Stable RA therapy for 12 weeks prior to baseline
  • Power Doppler Score >= 5 (for the PDUS 34 joint score)
  • Must use at least one highly effective method of contraception
  • Written informed consent

Exclusion Criteria:

  • Prior exposure to cannabis <= 28 days prior to baseline
  • Current diagnosed substance use disorders (including Alcohol Use Disorder)
  • Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
  • Chronic infections
  • 10mg of prednisone daily use

  • Daily use of central nervous system (CNS) depressant medications (e.g. sedatives, hypnotics [zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.])
  • Women who are pregnant, planning to become pregnant, or breast feeding
  • Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception
  • Deemed unsafe by the investigator
  • History of an allergic reaction or adverse reaction to cannabis is exclusionary.

Join this Trial

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Study Stats
Protocol No.
19-001551
Category
Rheumatology
Contact
Mia Vasquez-Gutierrez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04911127
For detailed technical eligibility, visit ClinicalTrials.gov.