At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cannabidiol for Fibromyalgia -The CANNFIB Trial Protocol for a Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial
In Brief
A Phase 3 clinical trial evaluating Cannabidiol and Placebo for Fibromyalgia. Completed, enrolled 200 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants will start with 10 mg of cannabidiol daily and the dose will be escalated every third day until the maximum dosage of 50 mg is reached (after two weeks). The participants be on the 50 mg dosage of cannabidiol for 24 weeks.
Placebo is administered as tablets of 10 mg that are identical in appearance, taste, and smell to the Cannabidiol tablets.The participants will be on the 50 mg dosage of placebo for 24 weeks.