Effects of phytocannabinoids on immune response in chronic inflammatory diseases
In Vitro Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
This study is testing whether phytocannabinoids like CBD and THC can help improve the immune response in people with chronic inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06842316 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of phytocannabinoids, such as cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC), on the immune response and autophagy in patients with chronic immune-mediated inflammatory diseases. By collecting blood samples as part of routine care, the study aims to explore how these compounds may modulate inflammation and immune function through their interaction with the endocannabinoid system. The research focuses on conditions like rheumatoid arthritis, spondyloarthritis, and inflammatory bowel diseases, assessing the potential therapeutic benefits of phytocannabinoids in these populations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed diagnoses of rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, systemic lupus erythematosus, or Sjögren's disease.
Not a fit: Patients currently using high doses of corticosteroids or those consuming CBD or recreational cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into the use of phytocannabinoids as a treatment option for patients with chronic inflammatory diseases.
How similar studies have performed: While there is emerging evidence supporting the anti-inflammatory effects of phytocannabinoids, this specific approach remains novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥ 18 years old 2. Diagnosis confirmed by a rheumatologist of RA or spondyloarthropathy (with or without IBD) or psoriatic arthritis (with or without active psoriasis) or systemic lupus erythematosus or Sjögren's disease 3. Patient who has expressed consent to participate in the study 4. Patients affiliated to social security 5. Treatments authorized as part of routine care: non-steroidal anti-inflammatory drugs (NSAIDs), level 1 to 3 analgesics, local corticosteroids, oral corticosteroid therapy (daily dose ≤15 mg/d), 5-aminosalicylic acid, salazopyrine, methotrexate, leflunomide, hydroxychloroquine, biotherapies and targeted therapies. Exclusion Criteria: 1. Patient who received intravenous corticosteroid therapy less than 4 weeks ago 2. Patient receiving oral corticosteroid therapy with a daily dose \>15 mg/day 3. Consumption of CBD and/or recreational cannabis and/or positive saliva test for cannabis consumption and/or CBD 4. Pregnant and lactating women 5. Persons under guardianship or curatorship
Where this trial is running
Orléans
- CHU d'ORLEANS — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Carine Pr SALLIOT — CHU Orléans
- Study coordinator: Carine Pr SALLIOT, PhD
- Email: carine.salliot@chu-orleans.fr
- Phone: 02 38 22 99 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.