Fibromyalgia
Conditions
Keywords
Fibromyalgia, Microbiome, Cannabis, Chronic Pain
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. 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
DRUGCannabis 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.
DRUGSham 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.
Sponsors
American Fibromyalgia Syndrome Association
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Double-Blinded, Randomized Placebo-Controlled Trial
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation of microbiome composition or serum metabolomics with pain reduction | Three Months | Any correlation of the gut microbiome composition or serum metabolomics with pain reduction following a 3-months treatment period with cannabis oil. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality | Three Months | Change in Pittsburgh Sleep Quality Index following 3 months of treatment with cannabis oil. |
| Change in quality of life | Three Months | Change in Short-form health-questionnaire following 3 months of treatment with cannabis oil. |
| Change in anxiety and depression | Three Months | Change in Hospital anxiety and depression scale following 3 months of treatment with cannabis oil. |
| Pain Intensity | Three Months | Change in pain intensity as measured by the Numeric Rating Scale |
| Changes in gut microbiome and blood metabolites following 3 months treatment with cannabis oil | Three Months | Changes in gut microbiome and blood metabolites following 3 months of treatment with cannabis oil will be measured using 16rRNA sequencing of stool and mass spectrometry of plasma. |
| correlation of microbiome composition and serum metabolomics with clinical measures | Three Months | Significant correlations (using Kendall rank) of the relative abundance of measured gut bacteria and plasma metabolites with clinical measures including sleep, quality of life, anxiety, depression, and impression of change following a 3-month treatment period with cannabis oil. |
| Patient global impression of changes | Three Months | Patient global impression of change following 3 months of treatment with cannabis oil. |
Countries
Israel
Contacts
Primary ContactMay Haddad, PhD
Outcome results
None listed