About Canopy Growth’s clinical trial
This CBD trial in North America is possibly the first of its kind. The trial will be an examination of roughly 160 random adults with social anxiety disorder. For comparison purposes, one group of participants will receive an inactive drug, while another group will receive CBD oil. The detailed second stage of the study will also assess the efficiency, therapeutic effects, adequacy, and safety of CBD oil. This study will also examine the CBD oil’s effects on the human endocannabinoid system.
This clinical trial will use product CHI-902. The trial will happen over four weeks. Its first phase will involve participants taking 150 mg of CBD oil for the first week. The CBD oil will be divided into 50 mg and given three times per day. After the first week, the dosage will increase to 300 mg per day. This new dosage will be for three weeks.
Evaluation of the trial
This clinical study aims at evaluating the efficiency, tolerability, therapeutic effects, and safety of CBD oil. The study will also evaluate the effects of CHI-902 on the human endocannabinoids anandamide (the “bliss molecule”) and 2-AG, which are naturally occurring in the human body. The study will assess how CHI-902 affects two elements before and after the procedure.
This trial will assess and examine the following and compare with the placebo results:
- The efficiency of CHI-902 with social anxiety disorder.
- The tolerability and safety of CHI-902 in participants with social anxiety disorder.
- The effects of CHI-902 on various biomarkers in cases of social anxiety disorder.
Measuring the outcomes
Primary outcome standards are measured by the Liebowitz Social Anxiety Scale. Researchers will observe participants’ scores from the start to the end of the trial. They’ll then compare the results between the two groups (CBD and placebo). The scale has 24 items, which further split into two subscales. One subscale concerns performance anxiety, and the other scale concerns social situations.
The 24 items are measured on the fear experienced on a scale of 0–3 during the experiment situations. The same 24 items are then measured on the participant’s willingness to avoid the situations. Combining scores from both the fear and avoidance sections, a participant can score a maximum of 144. A score of less than 30 suggests that social anxiety disorder is unlikely. A score of 30–60 suggests that social anxiety disorder is likely, and a score of 60–90 implies that it’s very likely. Scores of higher than 90 imply that it’s extremely likely.
