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New treatment option for Fibromyalgia
Official title Biosignature of the Response to Treatment With Cannabis Oil in Individuals With Fibromyalgia
ClinicalTrials.gov ID: NCT06946940
What this study is testing
What is Cannabis Oil (5% THC/5% CBD)?
Cannabis Oil (5% THC/5% CBD) is an investigational medicine, being studied as a potential treatment for fibromyalgia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.