CANNA-TICS: Efficacy and safety of oral treatment with nabiximols in adults with chronic tic disorders – Results of a prospective, multicenter, randomized, double-blind, placebo controlled, phase IIIb superiority study

• Published in: Psychiatry research 2023-05, Vol.323, p.115135-115135, Article 115135
• Main Authors: Müller-Vahl, Kirsten R., Pisarenko, Anna, Szejko, Natalia, Haas, Martina, Fremer, Carolin, Jakubovski, Ewgeni, Musil, Richard, Münchau, Alexander, Neuner, Irene, Huys, Daniel, van Elst, Ludger Tebartz, Schröder, Christoph, Ringlstetter, Rieke, Koch, Armin, Jenz, Eva Beate, Großhennig, Anika
• Format: Article
• Language: English
• Subjects: ADHD; Adult; Cannabis-based medicine; Double-Blind Method; Humans; Male; Nabiximols; OCD; Prospective Studies; Quality of Life; Randomized-controlled trial; Tic Disorders - drug therapy; Tics; Tourette syndrome; Tourette Syndrome - drug therapy
• ISSN: 0165-1781; 1872-7123
• DOI: 10.1016/j.psychres.2023.115135

•New treatment strategies are urgently needed to improve the full spectrum of symptoms related to Tourette syndrome/ chronic tic disorders including psychiatric comorbidities.•This is the first well-designed randomized, placebo-controlled, multicenter trial examining efficacy and safety of the nabiximols.•Nabiximols can be regarded as a safe treatment.•There was a clear trend for improvement of tics, depression, and quality of life.•Nabiximols seem to be more effective in reducing tics in males, patients with more severe tics at baseline, and in patients with comorbid attention deficit/ hyperactivity disorder. Preliminary data suggest that cannabis-based medicines might be a promising new treatment for patients with Tourette syndrome (TS)/chronic tic disorders (CTD) resulting in an improvement of tics, comorbidities, and quality of life. This randomized, multicenter, placebo-controlled, phase IIIb study aimed to examine efficacy and safety of the cannabis extract nabiximols in adults with TS/CTD (n = 97, randomized 2:1 to nabiximols:placebo). The primary efficacy endpoint was defined as a tic reduction of ≥ 25% according to the Total Tic Score of the Yale Global Tic Severity Scale after 13 weeks of treatment. Although a much larger number of patients in the nabiximols compared to the placebo group (14/64 (21·9%) vs. 3/33 (9·1%)) met the responder criterion, superiority of nabiximols could formally not be demonstrated. In secondary analyses, substantial trends for improvements of tics, depression, and quality of life were observed. Additionally exploratory subgroup analyses revealed an improvement of tics in particular in males, patients with more severe tics, and patients with comorbid attention deficit/hyperactivity disorder suggesting that these subgroups may benefit better from treatment with cannabis-based medication. There were no relevant safety issues. Our data further support the role of cannabinoids in the treatment of patients with chronic tic disorders.