Clinical Trial Finder

Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04911127
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Los Angeles
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ziva Cooper, PhDVeena Ranganath, MD, MS
Principal Investigator Affiliation University of California, Los AngelesUniversity of California, Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Cannabis
Additional Details

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 adjunctive for rheumatoid arthritis (RA) patients on stable therapy. Patients with moderate to severe RA meeting study inclusion criteria will be randomly assigned to one of three treatment groups (CBD 200 mg BID, CBD 400 mg BID, or placebo). Patients in all groups will receive CBD or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Participants will take capsules containing medium chain triglyceride (MCT) oil

Experimental: 200mg CBD twice daily

Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily

Experimental: 400 mg CBD twice daily

Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily

Interventions

Drug: - 200mg Cannabidiol by capsules twice daily

200mg twice daily via 50mg capsules

Drug: - 400mg Cannabidiol by capsules twice daily

400mg twice daily via 50mg capsules

Drug: - Placebo capsules

MCT oil capsules as placebo for CBD

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095

Site Contact

Nicolette Morris

[email protected]

310-825-9956

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