Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia

Overview

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.

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-blinded randomized controlled trial, where 150 patients with fibromyalgia will be treated with either a careful titration of cannabis oil (5% THC, 5% CBD) or placebo with an allocation ratio of 4:1. Patient reported outcomes, quantitative sensory testing and gut microbiome and metabolome composition will be evaluated at baseline and during treatment. Subjective and objective clinical outcomes will be compared to baseline and end-of-study gut microbiome composition and metabolomic profile.

Interventions

• Drug Cannabis Oil (5% THC/5% CBD)
  Cannabis oil containing a balanced formulation of 5% tetrahydrocannabinol (THC) and 5% cannabidiol (CBD). Administered sublingually over a three-month period, starting with a six-week titration phase to optimize dosing, followed by maintenance.
• Drug Sham Cannabis Oil
  Placebo oil visually and chemically matched to the active cannabis oil but devoid of active cannabinoids (THC/CBD). Administered sublingually over three months, mirroring the active arm's titration and maintenance schedule.

Primary outcome measures

• correlation of microbiome composition or serum metabolomics with pain reduction [Time frame: Three Months]

Secondary outcome measures (7)

• Pain Intensity [Time frame: Three Months]
• Change in sleep quality [Time frame: Three Months]
• Change in quality of life [Time frame: Three Months]
• Change in anxiety and depression [Time frame: Three Months]
• Patient global impression of changes [Time frame: Three Months]
• Changes in gut microbiome and blood metabolites following 3 months treatment with cannabis oil [Time frame: Three Months]
• correlation of microbiome composition and serum metabolomics with clinical measures [Time frame: Three Months]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Rambam Health Care Campus — Haifa

Identifiers

NCT: NCT06946940 · 0576-22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗