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Cannabidiol for Fibromyalgia (The CANNFIB Trial)

NCT04729179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Cannabidiol

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Marius Henriksen

    lead OTHER

Principal Investigators

  • Kirstine Amris, Dr. Med · The Parker Institute, Frederiksberg University Hospital, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729179 on ClinicalTrials.gov