CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg Universitetshospital; Aalborg University Hospital
• Collaborator: Aalborg University
• Treatments: Cannabidiol

Criteria

Inclusion Criteria Hand-OA:

• Patients (18 years or more) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)

• Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

• VAS pain during the last 24 hours 30mm or more

• Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.

Inclusion criteria PsA

• Patients (18 years or more) with PsA according to the Calcification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)

• Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

• VAS pain during the last 24 hours 30mm or more

• Negative pregnancy test (serum human chorionic gonadotropin (HCG)) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.

Exclusion Criteria:

• Concurrent diagnosis of chronic regional pain syndrome or neuropathy

• Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout not in remission)

• Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowel disease) or patients who have received systemic corticosteroid treatment during the last 3 months.

• Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)

• Planned major surgery or recent major surgery (last 8weeks)

• Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs. Determined through patient interview and medical records.

• Contraindication to medical cannabis (Known allergy to ingredients, history of severe liver or kidney disease, history of schizophrenia or other serious psychiatric disease).

• Verified malignant disease

• History of epilepsy or severe cramps

• History of serious cardiovascular pathology

• Lacking ability to corporate with the research staff.

• Indication for changing the anti-inflammatory treatment regimen at baseline (PsA only).