Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To determine the analgesic dose-response characteristics of vapourized cannabinoids with varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios.

Secondary Objectives:

• To compare functional changes and patient preferences of different cannabinoid (THC, CBD) profiles in patients with OA (Osteoarthritis);

• To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid profiles in patients with OA;

• To explore the short term safety of vapourized cannabis with different cannabinoid profiles.

• To describe the incidence and severity of psychoactive events.

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

Details

• Lead Sponsor: Prairie Plant Systems Inc.
• Collaborators: Algorithme Pharma Inc; Dalhousie University; McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre; Research Institute of the McGill University Health Center

Criteria

Inclusion Criteria:

1. Idiopathic (primary) OA of the knee as defined by American College of Rheumatology criteria

2. Age ≥50 years

3. Numerical Rating Scale (NRS) Pain intensity score ≥ 4 (on a 0-10 scale)

4. Stable medication and treatment regimen

5. Open to Canadian Residents only

Exclusion Criteria:

1. Pregnant/nursing

2. BMI >39kg/m2

3. Secondary causes of OA

4. Stage IV OA of the knee

5. Significant other cause of pain (e.g. fibromyalgia, CRPS)

6. Significant cardiac, neurological, psychiatric or respiratory disease

7. Joint infiltration in 30 days prior to trial or during study

8. Positive urine screen for THC