Status:
COMPLETED
Therapeutic Response of Cannabidiol in Rheumatoid Arthritis
Lead Sponsor:
University of California, Los Angeles
Conditions:
Rheumatoid Arthritis
Cannabis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 o...
Detailed Description
This is a randomized, placebo-controlled, double-blind clinical trial at the University of California, Los Angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (CBD) as adjunc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04911127
Start Date
October 5 2021
End Date
December 31 2023
Last Update
June 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, United States, 90095