Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Ziva Cooper, PhD (ucla)Veena Ranganath, MD, MS (ucla)

Description

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.

Official Title

Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis Cannabis Arthritis Arthritis, Rheumatoid Cannabidiol 200mg Cannabidiol by capsules twice daily 400mg Cannabidiol by capsules twice daily

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • UCLA David Geffen School of Medicine, Division of Rheumatology accepting new patients
    Los Angeles California 90095 United States

Lead Scientists at University of California Health

  • Ziva Cooper, PhD (ucla)
    Associate Professor-in-Residence, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 69 research publications
  • Veena Ranganath, MD, MS (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 50 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04911127
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated