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

NCT ID: NCT06946940

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2027-05-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Comparator: Cannabis Oil (5% THC/5% CBD)

Participants in this arm will receive cannabis oil containing a balanced formulation of 5% THC and 5% CBD. The intervention will span three months, including a six-week titration period to optimize dosing, followed by a maintenance phase. Doses will be self-administered sublingually and adjusted based on individual tolerance and efficacy. Comprehensive assessments will monitor clinical outcomes, gut microbiome composition, and circulating metabolomics to explore correlations with treatment response and safety.

This arm will comprise 120 patients.

Group Type: ACTIVE_COMPARATOR

Cannabis Oil (5% THC/5% CBD)

Intervention Type: 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 Comparator: Placebo Oil

Participants in this arm will receive placebo oil, which is visually and chemically matched to the active cannabis oil but contains no active cannabinoids (THC or CBD). Like the active arm, participants will undergo a three-month intervention, including a six-week titration period and maintenance phase. Outcomes, including clinical measures and biological analyses, will be used as a control to evaluate the therapeutic effects of the cannabis oil.

This arm will comprise 30 patients.

Group Type: SHAM_COMPARATOR

Sham Cannabis Oil

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Fibromyalgia Syndrome Association

OTHER

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Amir Minerbi MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Minerbi, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

May Haddad, PhD

Role: CONTACT

ma_haddad@rambam.health.gov.il

+9724-7772040 ext. +972

Facility Contacts

May Haddad, PhD

Role: primary

ma_haddad@rambam.health.gov.il

+9724-7772040 ext. +972

Other Identifiers

0576-22

Identifier Type: -

Identifier Source: org_study_id