Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jun 2015

Typical duration for phase_2

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

December 5, 2014

Completed

19 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed

Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.5 years

First QC Date

December 5, 2014

Last Update Submit

April 3, 2018

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

Total pain reduction of vapourized cannabinoids with varying degrees of THC/CBD ratios in patients with painful OA of the knee.
The main efficacy endpoint is pain reduction, calculated as a change in pain intensity (VAS pain intensity) following each exposure. A Total Pain Reduction (TOTPAR) score is calculated from repeated VAS pain scores taken immediately before (baseline) and every 15 minutes after exposure for the first hour then half-hourly for the remaining two hours after treatment exposure (treatment). The treatment VAS pain intensity scores are then subtracted from the baseline VAS pain intensity to generate a pain relief score for each time point. The sum of pain relief scores from each time point is used to generate a 3-hour Total Pain Reduction (TOTPAR-3) score for each exposure.
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose

Secondary Outcomes (11)

Pain, stiffness, physical, social and emotional functional outcomes of vapourized cannabis with varying degrees of THC/CBD ratios in patients with painful OA of the knee.
Up to 6 weeks
Pharmacokinetics profile of 7 plasma cannabinoid metabolites from vapourized cannabis of differing cannabinoid profiles in patients with OA.
0, 15, 30, 60, 120 and 180 minutes post-dose
Changes in blood pressure from baseline
Up to 7 weeks
Changes in heart rate (HR) from baseline
Up to 7 weeks
Blood chemistry - liver function
Up to 7 weeks
+6 more secondary outcomes

Study Arms (6)

CanniMed™ DPF-I Volcano® Vapourization

EXPERIMENTAL

Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation (DPF) with a potency specification similar to CanniMed™ 22·1 product, of 21.9% w/w total THC and 0.8% w/w total CBD is vapourized and inhaled by study subjects.