A 12-week study of 30 young people will trial the use of cannabidiol (CBD) for the treatment of anxiety symptoms where response to cognitive behavioural therapy (CBT) has failed.
This project aims to gather pilot data for a randomised placebo‐controlled trial to address an important clinical question: can anxiety symptoms in young people aged 12–25 years, who do not respond to cognitive behaviour therapy (CBT), be effectively treated with cannabidiol (CBD)?
The proposed study is a single-centre, 12-week open label trial of CBD for anxiety disorders. We aim to recruit 30 young people with anxiety disorders aged 12–25 years who failed to show clinically meaningful improvement to CBT. CBD will be administered on a fixed–flexible schedule adjusted up to maximum dose by week eight.
The primary endpoint is at 12 weeks. The study treatments will be provided in addition to bi-weekly CBT (five sessions). The trial will be conducted at the headspace Glenroy facility according to Good Clinical Practice guidelines, overseen by the trial sponsor, Orygen – The National Centre of Excellence in Youth Mental Health study service unit.
Project funded – 14 March 2017
Ethics submitted – 3 May 2017
Recruitment launch planned for – March 2018
Recruitment to run for six months to – September – November 2018
Three month analysis and write up to – February 2019
Dr Aswin Rateesh
Dr Sophie Adams
Dr Maximus Berger
Dr Emily Li
Dr Richard Kevin
Clinical, pilot study, open label clinical drug trial and treatment seeking patients
The Lambert Initiative
The clinical protocol has been written and ethics has been approved. The project will produce data on efficacy and safety of CBD in young people with anxiety disorders and will enable us to apply for external funding for a larger randomised controlled trial of CBD versus placebo for anxiety disorders.
Moreover, our project will develop new knowledge on the potential of CBD as a treatment for anxiety disorders, which constitute some of the most prevalent psychiatric disorders in Australian youth.
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