Exploring how gut bacteria affect cannabis oil treatment in fibromyalgia patients
Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
This study is testing how gut bacteria might affect how well cannabis oil works for people with fibromyalgia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Trial ID | NCT06946940 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between gut microbiome composition and the effectiveness of cannabis oil in treating fibromyalgia. It involves a double-blinded randomized controlled trial with 150 participants who will receive either cannabis oil (5% THC, 5% CBD) or a placebo. The study will assess patient-reported outcomes, sensory testing, and microbiome composition at baseline and during treatment. By analyzing these factors, researchers aim to understand why some patients respond better to cannabis oil than others.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 and over with a confirmed diagnosis of fibromyalgia and significant pain despite standard treatments.
Not a fit: Patients with recent cannabis use, significant comorbid conditions, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment approaches for fibromyalgia, improving pain management for patients.
How similar studies have performed: While there is growing interest in the use of cannabis for fibromyalgia, this specific approach linking gut microbiome composition to treatment response is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Haifa
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Amir Minerbi, MD-PhD — Rambam Health Care Campus
- Study coordinator: May Haddad, PhD
- Email: ma_haddad@rambam.health.gov.il
- Phone: +9724-7772040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.