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
52 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 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.
CONDITIONS
Brief 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 with symptoms lasting 12 months or more
- Average reported pain of 6 or higher during the preceding week
- Eligible for cannabis treatment as determined by the treating physician
- Remained symptomatic despite standard care including analgesics, antidepressants, and anti-epileptic agents
You will not qualify if you...
- Use of cannabis during the preceding month
- Significant comorbid conditions such as inflammatory arthritis, inflammatory bowel disease, or cancer
- Personal or family history of psychotic disorders
- Current or past anxiety disorder
- Any uncontrolled psychiatric condition
- 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 cannabis oil ingredients
- History of seizure disorder (excluding childhood febrile convulsions) or epilepsy
- Active liver disease
- Any contraindication to medical cannabis
- Inflammatory Bowel Disease (IBD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants begin a six-week titration phase to optimize dosing of cannabis oil or placebo, self-administered sublingually.
Weekly visits for up to 6 weeks
Duration - 6 weeks
Participants continue maintenance dosing of cannabis oil or placebo for the remaining duration of the three-month treatment period, with ongoing monitoring of clinical outcomes and biological samples.
Biweekly visits for 6 weeks
Duration - Up to 1 week after treatment
Participants complete assessments comparing baseline and end-of-study outcomes, including clinical symptoms and gut microbiome and metabolomic profiles.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
Research Team
M
May Haddad, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here