Actively Recruiting
Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
Led by Rambam Health Care Campus · Updated on 2025-04-27
150
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
R
Rambam Health Care Campus
Lead Sponsor
A
American Fibromyalgia Syndrome Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women aged 30 years and over
- Diagnosis of fibromyalgia confirmed by a pain specialist according to 2016 criteria, with symptoms lasting 12 months or more
- Average reported pain score of 6 or higher during the preceding week
- Eligible for cannabis treatment as determined by the treating physician
- Persistent symptoms despite standard fibromyalgia care including analgesics, anti-depressants, and anti-epileptic agents
You will not qualify if you...
- Use of cannabis during the preceding month
- Significant comorbid conditions as determined by the principal investigator, including inflammatory arthritis, inflammatory bowel disease, or cancer
- Personal or family history of psychotic disorders
- Current or past anxiety disorder
- Uncontrolled psychiatric conditions
- Current or past substance addiction or abuse
- Diagnosed dementia or cognitive impairment
- Personal history of cardiovascular disease
- Pregnancy, lactation, or intention to conceive
- Known allergy to any cannabis oil ingredients
- History of seizure disorder (excluding childhood febrile convulsions) or epilepsy
- Active liver disease
- Any contraindication to medical cannabis use
- Inflammatory Bowel Disease (IBD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
Research Team
M
May Haddad, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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