Tilray has received approval from the U.S. government and successfully imported an initial shipment of medical cannabinoids into the U.S. to support two clinical trials led by NYU School of Medicine.
According to the company, the two studies will test the efficacy of cannabidiol, or CBD, to treat patients suffering from Alcohol Use Disorder (AUD) and patients suffering from AUD comorbid with Post-Traumatic Stress Disorder (PTSD). Tilray has provided a Good Manufacturing Practices (GMP)-certified CBD formulation in capsule form for the studies.
Michael Bogenschutz, M.D., Professor in the Department of Psychiatry at NYU School of Medicine, will lead one trial focused on testing CBD in patients with AUD, and Charles R. Marmar, M.D., the Lucius Littauer Professor and Chair of the Department of Psychiatry at NYU School of Medicine, will lead another trial testing CBD in patients with AUD comorbid with PTSD. Both trials are expected to begin recruitment in the summer of 2019 and will take place at NYU School of Medicine.
The first NYU led clinical trial is a double-blind, randomized study designed to assess CBD treatment in patients with AUD. NYU will evaluate the safety and tolerability of a daily CBD treatment regimen in an AUD population and assess the impact of CBD on neuropsychological and neurophysiological domains implicated in AUD.
The second clinical trial is a double-blind, randomized study designed to assess the safety, tolerability, efficacy, and effect size of CBD in reducing alcohol use and PTSD symptoms for those suffering from AUD comorbid with PTSD.
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