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Cannabidiol for Fibromyalgia (The CANNFIB Trial) (CANNFIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729179
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Cannabidiol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, placebo-controlled, parallel-group, single center trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Cannabidiol for Fibromyalgia -The CANNFIB Trial Protocol for a Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : February 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: 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: 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.
Other Name: Cannabidiol active ingredient

Placebo Comparator: 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.
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.
Other Name: Cannabidiol Placebo




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: From baseline to week 24 ]
    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.


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: From baseline to week 24 ]
    The first of six key secondary outcomes is change in sleep quality, measured with the Pittsburgh Sleep Quality Index; total score of overall sleep quality. Scores are ranging from 0 to 21, with lower scores indicating better sleep quality and higher scores indicating worse sleep quality.

  2. Sleep duration [ Time Frame: From baseline to week 24 ]
    The second of six key secondary outcomes is change in sleep duration, measured with the Pittsburgh Sleep Quality Index; sleep duration domain, with number of hours of actual sleep during the night.

  3. Objectively measured sleep duration [ Time Frame: From baseline to week 24 ]
    The third of six key secondary outcomes is change in objectively measured sleep duration, with number of hours of nightly sleep, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system.

  4. Objectively measured sleep patterns [ Time Frame: From baseline to week 24 ]
    The fourth of six key secondary outcomes is change in objectively measured sleep patterns, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system, in which the different sleep phases during the night are indicated.

  5. Activities of daily living [ Time Frame: From baseline to week 24 ]
    The fifth of six key secondary outcomes is change in Activities of Daily Living (ADL), measured with the Assessment of Motor and process skills (AMPS) test, which is an observation-based, standardized evaluation of the individual's ability to perform and complete activities of daily living. The measure is based on 16 ADL motor skills and 20 ADL process skills. Scores range from 0 to 4 on an ordinal scale, with 0 indicating the lowest level of ADL and 4 indicating the highest ADL level. Activities of daily living is also measured with the Activities of Daily Living Questionnaire, in which items are rated on a 4 point Likert scale from 0= no problem to 3=no longer able to complete the task. Scores are calculated for total and subscale scores and expressed as a percentage from 0 to 100%. Lower percentage indicates a higher ADL level, and higher percentage indicates a lower ADL level.

  6. Health-related quality of life [ Time Frame: From baseline to week 24 ]
    The sixth of six key secondary outcomes is change in quality of life, measured with the EuroQol Self-Rated Health Questionnaire, developed by the EuroQual group and international network of multidisciplinary researchers.The scores goes from 0 -100, with 0 indicating the worst possible health condition and 100 indicating the best possible health condition.


Other Outcome Measures:
  1. Sleep latency [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in sleep latency, measured with the Pittsburgh Sleep Quality Index; sleep latency domain, scored on an 0-3 interval scale, on which 0 is indicating more problems with sleep latency and higher score less problems with sleep latency.

  2. Pain self-efficacy [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in pain self-efficacy, measured with the Pain Self-Efficacy Questionnaire, consisting of 10 items from 0 to 6 yielding a total score from 0 to 60. Lower scores are indicating lower levels of pain self-efficacy and higher scores are indicating higher levels of pain self-efficacy.

  3. Stiffness [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in stiffness, measured with the Fibromyalgia Impact Questionnaire Revised; stiffness subscale, which is an 11- point numieric rating scale of 0-10, with 10 being the worst outcome indicating the highest level of stiffness, and lower scores indicating less stiffness.

  4. Energy level [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in energy, measured with the Fibromyalgia Impact Questionnaire Revised; energy subscale, which is an 11- point numeric rating scale of 0-10, with10 being the worst outcome, indicating the lowest level of energy, and lower scores indicating higher levels of energy.

  5. Objectively measured physical activity [ Time Frame: From baseline to week 24 ]
    Change in objectively measured physical activity, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system, in which the number of minutes of physical activity are calculated during a week of measurement.

  6. Feeling rested [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in feeling rested, measured with the Fibromyalgia Impact Questionnaire Revised; rested subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating not feeling rested, and lower scores indicating feeling more rested.

  7. Depression [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in depression, measured with the Fibromyalgia Impact Questionnaire Revised; depression subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating depression, and lower scores indicating less depression, and the Depression, Anxiety, Stress Scale (DASS), depression subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more depression and lower scores less depression.

  8. Anxiety [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in anxiety, measured with the Fibromyalgia Impact Questionnaire Revised; anxiety subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more anxiety, and lower scores indicating less anxiety, and the Depression, Anxiety, Stress Scale (DASS), anxiety subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more anxiety and lower scores less anxiety.

  9. Perceived stress [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in perceived stress, measured with the Fibromyalgia Impact Questionnaire Revised; stress subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more stress, and lower scores indicating less stress, and the Depression, Anxiety, Stress Scale (DASS), stress subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more stress and lower scores less stress.

  10. Cortisol concentration in hair [ Time Frame: From baseline to week 24 ]
    Change in cortisol concentration in hair, with hair clipping analysis as a biomarker for prolonged stress. Higher cortisol concentration in hair is indicating higher stress levels.

  11. Memory problems [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in memory problems, measured with the Fibromyalgia Impact Questionnaire Revised; memory subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more memory problems, and lower scores indicating less memory problems.

  12. Tenderness level [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in tenderness level, measured with the Fibromyalgia Impact Questionnaire Revised; tenderness subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more tenderness, and lower scores indicating less tenderness.

  13. Balance problems [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in balance problems, measured with the Fibromyalgia Impact Questionnaire Revised; balance subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more balance problems, and lower scores indicating less balance problems.

  14. Environmental sensitivity [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in environmental sensitivity, measured with the Fibromyalgia Impact Questionnaire Revised; environmental sensitivity subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more environmental sensitivity, and lower scores indicating less environmental sensitivity, and the Fibromyalgia Sensory Hypersensitivity Scale, which is 9 item scale ranging from 0-3 with the maximum score of 27 being the worst outcome indicating the highest level of environmental sensitivity and lower levels indicating less environmental sensitivity.

  15. Pressure pain threshold and tolerance [ Time Frame: From baseline to week 24 ]
    Change in pressure pain threshold and tolerance, measured with computerized cuff pressure algometry. Pain threshold is defined as the pressure of the cuff at the subjects first sensation of pain when applying constantly rising pressure. Pain tolerance is defined as the worst tolerable pain caused by the pressure stimulation and the pressure is switched off by the patient. Lower pressures indicates low pressure pain threshold and tolerance, and higher pressures indicates higher pain threshold and tolerance.

  16. Muscle fatiguability [ Time Frame: From baseline to week 24 ]
    Change in muscle fatiguability, measured with a static muscle exhaustion test performed during which surface electromyography is recorded. The more muscle exhaustion detected, the more muscle fatiguability.

  17. Appetite [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in appetite, measured with the Simplified Nutritional Appetite Questionnaire, which is a 5 item scale each ranging from 1 to 5, yielding a maximun score of 25. Higher scores are indicating a greater appetite and lower scores are indicating reduced appetite.

  18. Body weight [ Time Frame: From baseline to week 24 and from baseline to week 36 ]
    Change in body weight, measured using an electronic scale.

  19. Body composition [ Time Frame: From baseline to week 24 ]
    Change in body composition, measured by the bioimpedance measurement conducted using the device named Impedimed model Sfb7, which measures impedance (resistance) through weak electric current flowing through body tissues over a spectrum of frequencies, to detect different body compositions such as body fat and muscle mass, total body water and fat free body mass.

  20. Waist circumference [ Time Frame: From baseline to week 24 ]
    Change in waist circumference, will be measured using a tape measure to the nearest 0.1 cm. as a measure of body fat distribution.

  21. Hip circumference [ Time Frame: From baseline to week 24 ]
    Change in hip circumference, will be measured using a tape measure to the nearest 0.1 cm. as a measure of body fat distribution.

  22. Pain intensity [ Time Frame: From baseline to week 36 ]
    Change in pain intensity, measured with the 0-10 pain Numeric Rating Scale (NRS) item 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.

  23. Sleep quality [ Time Frame: From baseline to week 36 ]
    Change in sleep quality, measured with the Pittsburgh Sleep Quality Index; total score to measure overall sleep quality. Scores are ranging from 0 to 21, with lower scores indictating a better sleep quality and higher scores a worse sleep quality.

  24. Sleep duration [ Time Frame: From baseline to week 36 ]
    Change in sleep duration, measured with the Pittsburgh Sleep Quality Index; sleep duration domain, with number of hours of actual sleep during the night.

  25. Activities of daily living [ Time Frame: From baseline to week 36 ]
    Change in activities of daily living, measured with the Activities of Daily Living Questionnaire, in which items are rated on a 4 point Likert scale from 0= no problem to 3=no longer able to complete the task. Scores are calculated for total and subscale scores and expressed as a percentage from 0 to 100%. A lower scores percentage indicates a higher level of ADL, and higher percentage indicates a lower level of ADL.

  26. Health-related quality of life [ Time Frame: From baseline to week 36 ]
    Change in quality of life, measured with the EuroQol Self-Rated Health Questionnaire, developed by the EuroQual group and international network of multidisciplinary researchers.The scores goes from 0 -100, with 0 indicating the worst possible health condition and 100 indicating the best possible health condition.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729179


Contacts
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Contact: Marianne U Rasmussen, PhD +4538164197 marianne.uggen.rasmussen@regionh.dk
Contact: Kirstine Amris, Dr. Med +4538164187 kirstine.amris@regionh.dk

Locations
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Denmark
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000
Contact: Marianne U Rasmussen, PhD    0045 38164197    marianne.uggen.rasmussen@regionh.dk   
Contact: Line Rustad    0045 38164158    line.rustad@regionh.dk   
Principal Investigator: Kirstine Amris, DMSc         
Sub-Investigator: Marianne U Rasmussen, PhD         
Sponsors and Collaborators
Marius Henriksen
Investigators
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Principal Investigator: Kirstine Amris, Dr. Med The Parker Institute, Frederiksberg University Hospital, Copenhagen, Denmark
  Study Documents (Full-Text)

Documents provided by Marius Henriksen, Frederiksberg University Hospital:
Publications:
Sundhedsstyrelsen, Callesen H, von Bülow C, Birkefoss K, Rasmussen M (2018) Nationale kliniske retningslinjer for udredning og behandling samt rehabilitering af patienter med genrelaliserede smerter i bevægeapparatet. https://www.sst.dk/da/udgivelser/2018/~/media/82268C6BAF19461399C4FC8D1647DCC0.ashx.
Lov om forsøgsordning med medicinsk cannabis. https://www.retsinformation.dk/Forms/R0710.aspx?id=196748 (2018).
Nabilone. https://pubchem.ncbi.nlm.nih.gov/compound/Nabilone#section=Top (2018)
Banerjee S, McCormack S Medical Cannabis for the Treatment of Chronic Pain: A Review of Clinical Effectiveness and Guidelines. Ottawa: CADTH; 2019 Jul. (CADTH rapid response report: summary with critical appraisal).
Fisher, A. G. (2010) Assessment of Motor and Process Skills: Development, Standardization, and Administration Manual. Fort Collins, Colorado: Three Star Press.
Sens Motion (2020) Discrete Wearable Acticity Sensor for Healthcare and Research.
ImpediMed, SFB7 (2020) ImpediMed.
Pro.medicin Information til sundhedsfaglige (2018) Sativex. https://pro.medicin.dk/Medicin/Praeparater/6456.
Greenwich Biosciences I (2020) Epidiolex Highlights of Prescibing Information.
(2020) Epidyolex Summary of product characteristics.

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Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT04729179    
Other Study ID Numbers: P142
2019-002394-59 ( EudraCT Number )
H-20047715 ( Other Identifier: Regional Ethical Committee Journal Number )
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marius Henriksen, Frederiksberg University Hospital:
Cannabidiol
Chronic widespread pain
Sleep disturbances
Fatigue
Functional ability
Quality of life
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Epidiolex
Anticonvulsants