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

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.

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