Cannabidiol for Fibromyalgia (The CANNFIB Trial)

• Status: Recruiting
• Trial end date: 2023-02-10
• Target enrollment: 0
• Participant gender: All

Summary

Fibromyalgia is serious chronic pain condition which is often accompanied by sleep disturbances, fatigue and disability and reduced quality of life. There is no cure and treatments are based on reliving symptoms and maintaining function. The currently available medical treatments are not helping many patients, and many get side-effects. Medical cannabis is sought after among patients and many use this medication un-licenced, although it is not properly documented if it works or is safe. Therefore, it is necessary to investigate the effects and safety of medical cannabis in a properly designed randomized trial. The aim of the study is to investigate if cannabidiol (CBD) can improve pain, sleep, function and quality of life in patients with fibromyalgia. The study will include 200 patients, who will receive either cannabidiol or placebo over a period of 24 weeks. Participants will be closely looked after for improvements in their condition and for potential side-effects to ensure safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marius Henriksen
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

• Informed consent obtained

• Clinical diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 1990 criteria

• Average pain intensity ≥ 4 on a Numeric Rating Scale

• No use of medical cannabis (THC/CBD) within the last six months

• Proficiency in spoken Danish language and able to read and write in Danish

Exclusion Criteria:

• On-going participation in other medical trials for pain management of fibromyalgia

• Diagnosis of Rheumatoid Arthritis or other inflammatory diseases

• Diagnosis of other serious chronic diseases

• Impaired liver and kidney function

• Pregnancy or insufficient anti-conception therapy for fertile female participants

• Planning pregnancy or insufficient anti-conception use in fertile female partners of male participants

• Breast feeding

• Surgery scheduled for the trial period or within 3 months prior to enrollment

• History of or current diagnosis of cancer

• History of or current epilepsy and seizures

• History of or major depressive disorder

• History of a suicide attempt or any suicidal behavior

• A mental state that may impede compliance with the program

• History of severe psychiatric disorders

• History of or current cannabis abuse

• History of or current drug abuse

• History of or current alcohol abuse

• Severe personality disorder

• Current use of opioids, opioid antagonists (LDN) or similar strong analgesics

• Allergic reactions to the active ingredients in cannabidiol