Exploring how gut bacteria affect cannabis oil treatment in fibromyalgia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.