Use of Cannabis Oil in Fibromyalgia

NCT07194018 | Active Not Recruiting

• 1 other identifier: ASO.TerD.24.01
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Pain Management; Cannabis; Retrospective Studies

Outcome Measures

Primary Outcomes (1)

• Pain relief

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

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Number of adverse events

  Through study completion, an average of 1 year

• Severity of adverse events

  Through study completion, an average of 1 year

• Adherence to therapy

  Every day through study completion, an average of 1 year

Interventions

Use of cannabis oil DRUG

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥ 21 years who have been diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) diagnostic criteria and who have failed previous therapies.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

Clinical Trial Center

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Conditions

Fibromyalgia; Agnosia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 26, 2025
• Study Start: October 19, 2024
• Primary Completion: February 19, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)