FibromyalgiaPhase 2CAN-RCTNCT06946940
Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
A Phase 2 study testing Cannabis Oil (5% THC/5% CBD) in people with Fibromyalgia, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cannabis Oil (5% THC/5% CBD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 30 May 2024to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
May Haddad, PhD, +9724-7772040 ext. +972, ma_haddad@rambam.health.gov.il
Amir Minerbi, MD-PhD
About this study
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.
Read the 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
- Being tested
- Cannabis Oil (5% THC/5% CBD), Sham Cannabis Oil
- Keywords
- Fibromyalgia, Microbiome, Cannabis, Chronic Pain
- Medical subject headings
- Fibromyalgia, Marijuana Abuse, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 OilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sham Cannabis Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Months
Secondary outcomes (7)
Pain Intensity
Change in pain intensity as measured by the Numeric Rating Scale
Measured: Three Months
Change in sleep quality
Change in Pittsburgh Sleep Quality Index following 3 months of treatment with cannabis oil.
Measured: Three Months
Change in quality of life
Change in Short-form health-questionnaire following 3 months of treatment with cannabis oil.
Measured: Three Months
Change in anxiety and depression
Change in Hospital anxiety and depression scale following 3 months of treatment with cannabis oil.
Measured: Three Months
Patient global impression of changes
Patient global impression of change following 3 months of treatment with cannabis oil.
Measured: Three Months
Changes in gut microbiome and blood metabolites following 3 months treatment with cannabis oil
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.
Measured: Three Months
correlation of microbiome composition and serum metabolomics with clinical measures
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.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blinded, Randomized Placebo-Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- American Fibromyalgia Syndrome Association
- Responsible party
- Principal investigator, Amir Minerbi MD, Rambam Health Care Campus
- Investigators
- Amir Minerbi, MD-PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946940
- Sponsor's protocol ID
- 0576-22
- Acronym
- CAN-RCT
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, raw data and analyses will be made available once the data analysis is complete and the study results are ready for peer review.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06946940
- Acronym / sponsor ID
- CAN-RCT / 0576-22
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Microbiome, Cannabis, Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- American Fibromyalgia Syndrome Association
- Study start
- 30 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blinded, Randomized Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Cannabis Oil (5% THC/5% CBD) | Active comparator | Drug: 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. |
| Sham Comparator: Placebo Oil | Sham comparator | Drug: Sham Cannabis OilParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Active Comparator: Cannabis Oil (5% THC/5% CBD) |
| Sham Cannabis OilPlacebo 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. | Drug | Sham Comparator: Placebo Oil |
Primary outcome
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.
7 secondary outcomes
Pain Intensity
Time frame: Three Months
Change in sleep quality
Time frame: Three Months
Change in quality of life
Time frame: Three Months
Change in anxiety and depression
Time frame: Three Months
Patient global impression of changes
Time frame: Three Months
Changes in gut microbiome and blood metabolites following 3 months treatment with cannabis oil
Time frame: Three Months
correlation of microbiome composition and serum metabolomics with clinical measures
Time frame: Three Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. Study protocol, raw data and analyses will be made available once the data analysis is complete and the study results are ready for peer review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Minerbi, MD-PhD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis Oil (5% THC/5% CBD) in people with Fibromyalgia, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact May Haddad, PhD (+9724-7772040 ext. +972, ma_haddad@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of microbiome composition or serum metabolomics with pain reduction (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.