A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.

NCT06513507 | Active Not Recruiting

• 1 other identifier: 20441
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.

Conditions

Rheumatoid Arthritis; Inflammatory Disease

Keywords

Arthritis Treatment; Cannabinoid Therapy; Anti-CCP

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory markers from Baseline to Week 8

  Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8.

  Baseline, Week 2, Week 4, Week 6, and Week 8

Secondary Outcomes (1)

• Change in self-reported symptoms and quality of life from Baseline to Week 8

  Baseline, Week 4, and Week 8

Study Arms (1)

CBG Treatment

EXPERIMENTAL

Participants will receive 0.5 milliliters of purified cannabigerol (CBG) in sesame oil once daily in the evening for a duration of eight weeks.

Dietary Supplement: Cannabigerol (CBG)

Interventions

Cannabigerol (CBG) DIETARY_SUPPLEMENT

The daily dose will consist of 50 mg of CBG. Blood tests will be conducted at Baseline, Week 2, Week 4, Week 6, and Week 8 to monitor inflammatory markers and immune response. Self-reported questionnaires will be completed at Baseline, Week 4, and Week 8 to assess symptoms and quality of life.

CBG Treatment

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, over 25 years of age
• Positive anti-CCP blood test
• Active RA-related inflammation with at least 2 swollen joints
• University graduate
• Generally healthy with no uncontrolled chronic disease
• Able to read, understand, and sign informed consent
• Resides in the USA
• Willing to comply with study requirements and avoid other cannabis products during the study period

You may not qualify if:

• Pre-existing chronic conditions preventing adherence
• Severe allergic reactions requiring an Epi-pen
• Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
• Pregnant or breastfeeding women
• Recent invasive medical procedure or surgery
• Active malignancy or ongoing oncology treatment
• Use of cytochrome P450 or 3A4 inhibitors
• History of substance abuse

Sponsors & Collaborators

• Raphael Pharma: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

cannabigerol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding will be performed in this study. All participants and investigators will know the treatment being administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-group study with an exploratory longitudinal prospective design aimed at measuring the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 22, 2024
• Study Start: June 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)