What this Trial Is About

Fibromyalgia (FM) is a chronic condition causing widespread pain, fatigue, sleep problems, mood changes, and other symptoms that significantly affect quality of life. This observational study investigates the effects of a cannabis extract called Avextra 10/10 solution, which contains equal amounts of THC and CBD, on pain and other symptoms in patients with FM. The main goal is to see if this cannabis extract improves pain after 12 weeks of treatment, along with effects on fatigue, sleep, anxiety, depression, and quality of life. Participants diagnosed with FM who have tried and not tolerated or failed other treatments will use the Avextra 10/10 solution. Assessments will take place at baseline, then at 15, 30, 60, 90 days, and 6 months after starting the cannabis extract. During these visits, patients will be evaluated through surveys and clinical assessments about their symptoms and any side effects or reasons for stopping treatment. During the study, participants will provide information on demographics, medical history, symptom duration, medication, and lifestyle factors. They will complete questionnaires on pain, fatigue, sleep, anxiety, depression, and quality of life at several time points. Researchers will monitor symptom changes, adverse events, and treatment adherence to evaluate the clinical effects and safety of the cannabis extract over 12 weeks and beyond.

Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study