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RECRUITING
NCT06946940
PHASE2

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

Sponsor: Rambam Health Care Campus

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-05-30

Completion Date

2027-05

Last Updated

2025-04-27

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Rambam Health Care Campus

Haifa, Israel