CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.

NCT03693833 | Completed Phase 2 DMC

• 1 other identifier: NordCAN
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriatic Arthritis; Hand Osteoarthritis

Keywords

Cannabidiol; Cannabis; Osteoarthritis; Psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

• VAS pain during the last 24 hours

  Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.

  Change from baseline to 12 weeks

Other Outcomes (6)

• Patients experiencing adverse events

  24 weeks

• Characterization of serious adverse events

  24 weeks

• Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.

  at 24week followup

Study Arms (2)

Intervention

EXPERIMENTAL

10mg Cannabidiol (CBD) tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

10mg Placebo Oral tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.

Drug: Placebo Oral Tablet

Interventions

Cannabidiol DRUG

Cannabidiol (CBD) tablets of 10mg each

Also known as: CBD

Intervention

Placebo Oral Tablet DRUG

Oral Placebo tablets of 10mg each

Also known as: Oral Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Department of Rheumatology Aalborg Universityhospital North

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Marijuana Abuse; Osteoarthritis

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jonathan Vela

  Dept. of rheumatology Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jonathan Vela MD

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: November 28, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

DK (1)