Evaluating cannabis extract for fibromyalgia symptoms
ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
This study is testing if a cannabis extract can help people with fibromyalgia feel less pain and improve their overall quality of life over 12 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06747039 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of the cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life in patients diagnosed with fibromyalgia syndrome. Participants will complete surveys regarding their symptoms at baseline, and then again at 4, 8, and 12 weeks after starting the treatment. The primary focus is to determine if the cannabis extract can significantly reduce pain after 12 weeks of use. Secondary objectives include evaluating its impact on fatigue, sleep, anxiety, and depression over the same period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of fibromyalgia who have not found relief from first- or second-line treatments.
Not a fit: Patients with fibromyalgia who are currently stable on other pain management therapies or those with psychiatric diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing fibromyalgia symptoms, potentially improving patients' quality of life.
How similar studies have performed: While cannabis-based treatments for fibromyalgia are gaining attention, this specific approach using Avextra 10/10 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria. * Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment. * Aged 18 years and older. * Able to fully understand and fill questionnaires. * Able to provide informed consent, according to requirements of local IRB/ethics committee. Exclusion Criteria: * Known history of pain not due to FM. * Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks. * Patients who are taking other types of medical cannabis besides Avextra 10/10 solution. * Concomitant diagnosis of other pathologies that could interfere with clinical judgment. * Psychiatric diagnosis according to DSM-V-TR * Pregnancy or breastfeeding
Where this trial is running
Milan, Milano
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Piercarlo Sarzi Puttini, Medical Doctor — IRCCS Ospedale Galeazzi Sant'Ambrogio
- Study coordinator: Greta Pellegrino, Medical Doctor
- Email: greta.pellegrino@grupposandonato.it
- Phone: 0283500010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.