Cannabidiol for Fibromyalgia (The CANNFIB Trial) (NCT04729179) | Clinical Trial Compass
CompletedPhase 3
Cannabidiol for Fibromyalgia (The CANNFIB Trial)
Denmark200 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.