NCT06946940

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Fibromyalgia is a chronic condition that causes widespread pain, fatigue, and other symptoms, significantly affecting quality of life. Unfortunately, there are few effective treatments available. Recently, medical cannabis has gained attention as a potential treatment, leading many countries to approve its use for fibromyalgia. However, its success is limited-only about 25% of patients experience meaningful pain relief, and side effects like dizziness or fatigue are common. Not everyone responds to medical cannabis the same way, and researchers think this variability may partly be explained by differences in the gut microbiome-the community of bacteria and other microorganisms living in our digestive system. These microbes are known to influence various aspects of health, including pain and how the body processes medications. Our research focuses on understanding the link between the gut microbiome and fibromyalgia. We propose a study where 150 fibromyalgia patients will be treated with either cannabis oil or a placebo in a double-blind trial. By analyzing their symptoms and gut microbiome, we hope to identify patterns that could predict who will benefit most from cannabis treatment. If successful, this research could lead to more personalized and effective treatment options for fibromyalgia.

Detailed description

This study aims to explore the potential association between the composition of the gut microbiome and the individual response to cannabis oil in individuals with fibromyalgia. We propose a double-blinded randomized controlled trial, where 150 patients with fibromyalgia will be treated with either a careful titration of cannabis oil (5% THC, 5% CBD) or placebo with an allocation ratio of 4:1. Patient reported outcomes, quantitative sensory testing and gut microbiome and metabolome composition will be evaluated at baseline and during treatment. Subjective and objective clinical outcomes will be compared to baseline and end-of-study gut microbiome composition and metabolomic profile.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Cannabis Oil (5% THC/5% CBD)	Cannabis oil containing a balanced formulation of 5% tetrahydrocannabinol (THC) and 5% cannabidiol (CBD). Administered sublingually over a three-month period, starting with a six-week titration phase to optimize dosing, followed by maintenance.
DRUG	Sham Cannabis Oil	Placebo oil visually and chemically matched to the active cannabis oil but devoid of active cannabinoids (THC/CBD). Administered sublingually over three months, mirroring the active arm's titration and maintenance schedule.

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: Israel