Study of Cannabis Oil Treatment Effects and Gut Microbiome Links in Adults with Fibromyalgia

What this Trial Is About

Fibromyalgia is a long-lasting condition causing widespread pain, fatigue, and other symptoms that greatly affect daily life. This research aims to find out how the gut microbiome, the community of microbes in the digestive system, may influence how individuals with fibromyalgia respond to cannabis oil treatment. The study is a double-blinded randomized controlled trial involving 150 patients to explore this connection and improve personalized treatments for fibromyalgia. Participants will receive either cannabis oil containing 5% THC and 5% CBD or a placebo oil without active cannabinoids. The treatment lasts three months, starting with a six-week period to carefully adjust doses, followed by a maintenance phase. The cannabis or placebo oil is taken under the tongue and dose adjustments depend on individual tolerance and effects. The study groups include 120 patients receiving cannabis oil and 30 receiving placebo. During the study, participants will report their symptoms and undergo tests measuring pain, sleep quality, anxiety, depression, and quality of life. Researchers will analyze gut microbiome and blood metabolite changes at the beginning and end of the study and relate these to clinical outcomes. The main goal is to find a link between microbiome or metabolite profiles and pain relief after three months. Safety and response will be monitored throughout the trial, which is sponsored by Rambam Health Care Campus.

Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia