Cannabidiol for Fibromyalgia (The CANNFIB Trial)
CompletedPhase 3NCT04729179
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Cannabidiol for Fibromyalgia -The CANNFIB Trial Protocol for a Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial
- Conditions
- Interventions
- Sponsor
- Marius Henriksen
- Organization
- Frederiksberg University Hospital
- Start date
- 2021-03-01
- Primary completion
- 2024-02-14
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04729179