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Calm, Cool, and Corrected: A First Look at Open Label Data from a CBD Clinical Trial for Anxiety

Tags: CBD, anxiety, clinical trial, open label, medicine

Staci Gruber, PhD presents “Calm, Cool, and Corrected: A First Look at Open Label Data from a CBD Clinical Trial for Anxiety” at CannMed 2022.

Acute administration studies in both animals and humans have demonstrated that cannabidiol (CBD) may have anxiolytic properties. However, to date, no clinical trials have assessed the efficacy of high CBD products for the treatment of anxiety and related symptoms. Accordingly, we are conducting the first clinical trial assessing the impact of a novel, proprietary high CBD, low THC sublingual product in patients who meet a minimum threshold of “moderate” anxiety and report no current use of any cannabinoid-based products. All patients completed ratings of anxiety, mood, and quality of life, as well as a comprehensive neuropsychological battery at baseline and again at weeks follow-up visits over the course of four-week treatment period. For the open label-phase, after completion of baseline assessments, all patients were provided with the study product, a custom-formulated, full-spectrum sublingual solution containing approximately 10mg/ml CBD, which they self-administered three times per day.

Data from the completed open-label phase of the trial suggests significant improvement on measures of anxiety, mood, and additional related measures following four weeks of treatment relative to baseline. In addition, the study product appears to be well-tolerated with no discernible side effect profile. While these results are promising and reflect findings from our larger observational study of medical cannabis patients, open-label results should be interpreted with caution; a definitive assessment of the impact of this novel treatment will be ascertained upon completion of the next phase of the trial, a double-blind, placebo-controlled study.


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