NCT04911127

Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Rheumatoid Arthritis
• Cannabis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-06-02
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study