Status:
COMPLETED
Cannabidiol for Fibromyalgia (The CANNFIB Trial)
Lead Sponsor:
Marius Henriksen
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 relivi...
Detailed Description
BACKGROUND: Fibromyalgia is a serious chronic pain condition affecting 2-5 % of the background population. The disease burden in most affected individuals is substantial; with widespread musculoskelet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04729179
Start Date
March 1 2021
End Date
February 14 2024
Last Update
March 25 2024
Active Locations (1)
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1
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000