EUCTR2019-002394-59-DKActive, not recruitingPhase 1
Medical Cannabis for fibromyalgia - The CANNFIB trialProtocol for a randomized, double-blind, placebo-controlled, parallelgroup,single-center trial
The Parker Institute, Bispebjerg and Frederiksberg Hospital0 sites200 target enrollmentStarted: July 8, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Informed consent obtained
- •Clinical diagnosis of fibromyalgia according to the American College of
- •Rheumatology (ACR) 1990 criteria
- •Adult individuals (Age =18 years and <75 years)
- •Average pain intensity = 4 on a Numeric Rating Scale (NRS)
- •No use of medical cannabis (THC/CBD) within the last six months
- •Proficiency in spoken Danish language and able to read and write in
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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 female fertile
- •participants
- •Planning pregnancy or insufficient anti-conception use in female fertile
- •partners of male participants
- •Breast feeding
- •Surgery scheduled for the trial period or within 3 months prior to
- •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 impeding compliance with the program
- •History of severe psychiatric disorders
- •History of or current abusive behavior of cannabis
- •History of or current abusive behavior of other drugs
- •History of or current abusive behavior of alcohol
- •Severe personality disorder
- •Current use of opioids, opioid antagonists (LDN) or similar strong
- •Allergic reactions to the active ingredients in cannabidiol
Investigators
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