Cannabidiol for Fibromyalgia (The CANNFIB Trial)

NCT04729179 | Completed Phase 3 DMC

• 3 other identifiers: P1422019-002394-59H-20047715
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Keywords

Cannabidiol; Chronic widespread pain; Sleep disturbances; Fatigue; Functional ability; Quality of life

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The primary endpoint is change in pain intensity, measured with the 0-10 pain numeric rating scale, from the Fibromyalgia Impact Questionnaire Revised. The minimum value is 0, which is the best outcome, indicating no pain. The maximum value is 10, which is the worst outcome, indicating the worst possible pain.

  From baseline to week 24

Secondary Outcomes (6)

• Sleep quality

  From baseline to week 24

• Sleep duration

  From baseline to week 24

• Objectively measured sleep duration

  From baseline to week 24

• Objectively measured sleep patterns

  From baseline to week 24

• Activities of daily living

  From baseline to week 24

Other Outcomes (26)

• Sleep latency

  From baseline to week 24 and from baseline to week 36

• Pain self-efficacy

  From baseline to week 24 and from baseline to week 36

• Stiffness

  From baseline to week 24 and from baseline to week 36

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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: Cannabidiol

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Cannabidiol DRUG

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.

Also known as: Cannabidiol active ingredient

Cannabidiol

Placebo DRUG

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.

Also known as: Cannabidiol Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Related Publications (64)

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MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Parasomnias; Fatigue

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kirstine Amris, Dr. Med

  The Parker Institute, Frederiksberg University Hospital, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The project medication is manufactured specifically for research purposes, and the cannabidiol and cannabidiol placebo pills are identical in appearance, taste, and smell. The cannabidiol and placebo tablet packages are labelled with a unique Dispensing Unit Number (DUN). It is concealed to all involved parties (the participant, care provider, investigator qand outcomes assessor), but the database manager, wether the DUN can be identified as cannabidiol package or a placebo package.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, double-blind, placebo-controlled, parallel-group, single center trial

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 28, 2021
• Study Start: March 1, 2021
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)