Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 1

Conditions: Cannabis; Rheumatoid Arthritis

Treatments: Drug: 200mg Cannabidiol by capsules twice daily; Drug: Placebo capsules; Drug: 400mg Cannabidiol by capsules twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT04911127

19-01551

P64-01-003 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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67 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo capsules

200mg CBD twice daily

Experimental group

Description:

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

Treatment:

Drug: 200mg Cannabidiol by capsules twice daily

400 mg CBD twice daily

Experimental group

Description:

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

Treatment:

Drug: 400mg Cannabidiol by capsules twice daily