RecruitingNCT06747039

Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study

ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

38 participants

Start Date

Dec 5, 2024

Study Type

OBSERVATIONAL

Conditions

Fibromyalgia (FM)

Summary

The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is: Does cannabis extract have a positive effect on pain after 12 weeks in these patients? Participants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10/10 solution.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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