FibromyalgiaFIBRO-CBNCT07194018
Use of Cannabis Oil in Fibromyalgia
An observational study of Fibromyalgia and Pain Management, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fibromyalgia, Pain Management, Cannabis
- What is being tested?
- Use of cannabis oil
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- written informed consent;
- age ≥ 21 years;
- diagnosis of FM according to the 2016 American College of Rheumatology (ACR) diagnostic criteria;
- failure of previous therapies.
Who cannot join
- psychiatric disorders,
- history of drug or alcohol addiction,
- fatty liver disease or severe liver disease,
- severe cardiopulmonary disease,
- severe renal failure,
- pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Cannabis Oil in Patients With 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.
Read the detailed description
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.
- Conditions
- Fibromyalgia, Pain Management, Cannabis, Retrospective Studies
- Being tested
- Use of cannabis oil
- Medical subject headings
- Fibromyalgia, Agnosia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of cannabis oilDrug
Use of cannabis oil on pain relief in patients suffering from fibromyalgia syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Scale Numeric Pain Rating Scale (NRS) for pain assessment from 0 (no pain) to 10 (maximum pain)
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Number of adverse events
Assess the number of adverse events
Measured: Through study completion, an average of 1 year
Severity of adverse events
Assess the severity of adverse events
Measured: Through study completion, an average of 1 year
Adherence to therapy
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%).
Measured: Every day through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start19 Oct 2024
- Primary completion19 Feb 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194018
- Sponsor's protocol ID
- ASO.TerD.24.01
- Acronym
- FIBRO-CB
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Cannabis Oil in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07194018
- Acronym / sponsor ID
- FIBRO-CB / ASO.TerD.24.01
- Conditions
- Fibromyalgia, Pain Management, Cannabis, Retrospective Studies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- written informed consent;
- age ≥ 21 years;
- diagnosis of FM according to the 2016 American College of Rheumatology (ACR) diagnostic criteria;
- failure of previous therapies.
Key exclusion criteria (6 listed)
- psychiatric disorders,
- history of drug or alcohol addiction,
- fatty liver disease or severe liver disease,
- severe cardiopulmonary disease,
- severe renal failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of cannabis oilUse of cannabis oil on pain relief in patients suffering from fibromyalgia syndrome | Drug | – |
Primary outcome
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)
3 secondary outcomes
Number of adverse events
Time frame: Through study completion, an average of 1 year
Severity of adverse events
Time frame: Through study completion, an average of 1 year
Adherence to therapy
Time frame: Every day through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Pain Management, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.