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NCT Number: NCT06946940

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

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.

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Key information

Conditions

Fibromyalgia Chemically-Induced Disorders Chronic Pain Marijuana Abuse Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Substance-Related Disorders

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location status: Recruiting

Location contact

Amir Minerbi, MD-PhD

PRINCIPAL_INVESTIGATOR

May Haddad, PhD

CONTACT

[email protected]

+9724-7772040 ext. +972

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. correlation of microbiome composition or serum metabolomics with pain reduction

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: Three Months

    Change in pain intensity as measured by the Numeric Rating Scale

  2. Change in sleep quality

    Time frame: Three Months

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

  3. Change in quality of life

    Time frame: Three Months

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

  4. Change in anxiety and depression

    Time frame: Three Months

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

  5. Patient global impression of changes

    Time frame: Three Months

    Patient global impression of change following 3 months of treatment with cannabis oil.

  6. Changes in gut microbiome and blood metabolites following 3 months treatment with cannabis oil

    Time frame: 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.

  7. correlation of microbiome composition and serum metabolomics with clinical measures

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

May Haddad, PhD

CONTACT

[email protected]

+9724-7772040 ext. +972

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • American Fibromyalgia Syndrome Association

Registry information

Acronym: CAN-RCT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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