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

NCT06946940 | Recruiting Phase 2

• 1 other identifier: 0576-22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Microbiome; Cannabis; Chronic Pain

Outcome Measures

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.

  Three Months

Secondary Outcomes (7)

• Pain Intensity

  Three Months

• Change in sleep quality

  Three Months

• Change in quality of life

  Three Months

• Change in anxiety and depression

  Three Months

• Patient global impression of changes

  Three Months

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Drug: Cannabis Oil (5% THC/5% CBD)

Sham Comparator: Placebo Oil

SHAM COMPARATOR

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.

Drug: Sham Cannabis Oil

Interventions

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.

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

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.

Sham Comparator: Placebo Oil

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• American Fibromyalgia Syndrome Association: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Marijuana Abuse; Chronic Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Study Officials

• Amir Minerbi, MD-PhD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

May Haddad, PhD

CONTACT

+9724-7772040; ma_haddad@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: A Double-Blinded, Randomized Placebo-Controlled Trial

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 27, 2025
• Study Start: May 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Estimated May 2027 for unlimited time.
• Access Criteria: All non identified data will be made publicly available.

Locations

IL (1)