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

ConditionFibromyalgia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorRambam Health Care Campus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabis Oil (5% THC/5% CBD)

    Drug

    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.

  • Sham Cannabis Oil

    Drug

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Active Comparator: Cannabis Oil (5% THC/5% CBD)Active comparator 1 intervention
Group B: Sham Comparator: Placebo OilSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

correlation of microbiome composition or serum metabolomics with pain reduction

Any correlation of the gut microbiome composition or serum metabolomics with pain reduction following a 3-months treatment period with cannabis oil.

Time frame
Three Months

Secondary outcomes

1

Pain Intensity

Change in pain intensity as measured by the Numeric Rating Scale

Time frame
Three Months
2

Change in sleep quality

Change in Pittsburgh Sleep Quality Index following 3 months of treatment with cannabis oil.

Time frame
Three Months
3

Change in quality of life

Change in Short-form health-questionnaire following 3 months of treatment with cannabis oil.

Time frame
Three Months
4

Change in anxiety and depression

Change in Hospital anxiety and depression scale following 3 months of treatment with cannabis oil.

Time frame
Three Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rambam Health Care Campus

Lead sponsor

American Fibromyalgia Syndrome Association

Collaborator