Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis Cannabis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

MCT oil capsules as placebo for CBD

200mg CBD twice daily

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

Group Type EXPERIMENTAL

200mg Cannabidiol by capsules twice daily

Intervention Type DRUG

200mg twice daily via 50mg capsules

400 mg CBD twice daily

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

Group Type EXPERIMENTAL

400mg Cannabidiol by capsules twice daily

Intervention Type DRUG

400mg twice daily via 50mg capsules

Interventions

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200mg Cannabidiol by capsules twice daily

200mg twice daily via 50mg capsules

Intervention Type DRUG

400mg Cannabidiol by capsules twice daily

400mg twice daily via 50mg capsules

Intervention Type DRUG

Placebo capsules

MCT oil capsules as placebo for CBD

Intervention Type DRUG

Other Intervention Names

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CBD CBD Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No