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Active, Not Recruiting

NCT Number: NCT07194018

Use of Cannabis Oil in Fibromyalgia

Recently, medical cannabis has been shown to be effective in chronic pain conditions such as osteoarthritis, neuropathic pain, and other chronic non-cancer pain.

A study showed that fibromyalgia patients who use cannabis report significant improvement in pain symptoms and quality of life. Patients reported a 50% reduction in pain, and many also reported improvements in sleep and overall well-being. Further research found that the use of medical cannabis among patients with fibromyalgia led to significant improvements in pain, sleep quality, and overall quality of life. This study emphasized that adverse effects were generally mild and tolerable. Furthermore, the systematic review by Fitz et al. concluded that cannabis may be effective in treating fibromyalgia, with preliminary evidence indicating improvements in pain and sleep disturbances. However, it also highlighted the need for further randomized controlled trials to confirm these findings and determine how the cannabinoid system interacts with the pain pathway.

Considering that medical cannabis is effective in treating a variety of symptoms, including pain, cachexia and wasting, sleep disorders, severe or persistent muscle spasms, reduced fatigue in multiple sclerosis, chemotherapy-induced nausea, convulsive disorders, post-traumatic stress disorder, and other conditions in palliative and end-of-life care; with this study, given the premises of the effects of medical cannabis, the aim is to analyze its use also in chronic pain as the main symptom of fibromyalgia syndrome.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

Fibromyalgia syndrome, also known simply as "fibromyalgia," is a central sensitization syndrome characterized by dysfunction of the neurocircuits responsible for the perception, transmission, and processing of nociceptive afferents, with pain predominantly manifested in the musculoskeletal system.

The link between pathophysiology and treatment is still very weak, and significant efforts are still needed to offer patients treatment targeted at the biological causes of the disease.

To date, the treatment of fibromyalgia is aimed at reducing the main symptoms and must be individualized and multidisciplinary, involving both non-pharmacological measures and, in most patients, drug therapy.

Cannabinoids or cannabinols are chemicals that share the ability to interact with cannabinoid receptors and can be of three types: endocannabinoids, synthetic cannabinoids, and phytocannabinoids.The Company Therapeutic Handbook (PTA) from the hospital pharmacy of the AOU "SS Antonio e Biagio e Cesare Arrigo" in Alessandria provides for the use of cannabis oil from September 2022. Considering that medical cannabis is effective in treating multiple symptoms, including pain, cachexia and wasting, sleep disorders, severe or persistent muscle spasms, and others, this study aims to analyze its use in chronic pain as the main symptom of fibromyalgia syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written informed consent;
  • age ≥ 21 years;
  • diagnosis of FM according to the 2016 American College of Rheumatology (ACR) diagnostic criteria;
  • failure of previous therapies.

Exclusion criteria

  • psychiatric disorders,
  • history of drug or alcohol addiction,
  • fatty liver disease or severe liver disease,
  • severe cardiopulmonary disease,
  • severe renal failure,
  • pregnancy or breastfeeding.

Treatment and study plan

Use of cannabis oil

Drug

Use of cannabis oil on pain relief in patients suffering from fibromyalgia syndrome

Primary outcomes

  1. Pain relief

    Time frame: Through study completion, an average of 1 year

    Scale Numeric Pain Rating Scale (NRS) for pain assessment from 0 (no pain) to 10 (maximum pain)

Secondary outcomes

  1. Number of adverse events

    Time frame: Through study completion, an average of 1 year

    Assess the number of adverse events

  2. Severity of adverse events

    Time frame: Through study completion, an average of 1 year

    Assess the severity of adverse events

  3. Adherence to therapy

    Time frame: Every day through study completion, an average of 1 year

    Assessment of medication intake in the indicated doses and times (patient is "adherent" if they take at least 80% of the prescribed doses , "partially adherent" if they take between 20% and 80%, and "non-adherent" if they take less than 20%).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Evaluation of the Use of Cannabis Oil in Patients With Fibromyalgia

Acronym: FIBRO-CB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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