Status:
RECRUITING
Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
American Fibromyalgia Syndrome Association
Conditions:
Fibromyalgia
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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. Rece...
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-bli...
Eligibility Criteria
Inclusion
- Adult men and women aged 30 years and over.
- Diagnosis of fibromyalgia confirmed according to the 2016 diagnostic criteria by a pain specialist, with relevant symptoms lasting 12 months or more.
- An average reported pain ≥ 6 during the preceding week.
- Eligible for cannabis at the discretion of the treating physician.
- Has remained symptomatic despite receiving standard care for fibromyalgia including analgesics, anti-depressants (tricyclic and SNRI) and anti-epileptic agents.
Exclusion
- Patients who have used cannabis during the preceding month.
- Any significant comorbid condition at the discretion of the PI (e.g. inflammatory arthritis, inflammatory bowel disease, cancer).
- Personal or family history of psychotic disorders.
- Current or past anxiety disorder.
- Any uncontrolled psychiatric pathology.
- Current or history of substance addiction or abuse.
- Diagnosed dementia or cognitive impairment.
- Personal history of cardiovascular disease.
- Pregnancy, lactation or intention to conceive.
- Known allergy to any of the cannabis oil ingredients.
- Patients with a history of seizure disorder (excluding childhood febrile convulsions) or epilepsy.
- Active liver disease.
- Any contraindication to the use of MC.
- Inflammatory Bowel Disease (IBD).
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06946940
Start Date
May 30 2024
End Date
May 1 2027
Last Update
April 27 2025
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel, 3109601