US biotech firm Ananda Scientific has launched clinical trials of a cannabis-based treatment post-traumatic stress disorder (PTSD).
The company has teamed up with New York University Grossman School of Medicine to carry out the eight-week study.
The Phase II double-blind, randomised trial will involve 120 patients in a large scale placebo-controlled experiment which could be a breakthrough moments for the drug.
If successful, the trial will be an important step on the journey to winning regulatory approval Ananda’s Nantheia treatment, a drug incorporating CBD into a liquid application.
PTSD is a common mental health disorder which occurs in people following a traumatic experience and is a particular problem among people who have served in the armed forces.
A 2014 study found as many as 12.9% of US soldiers who served in Iraq displayed some symptoms of PTSD.
Recent months have seen warnings health workers on the front line during the Covid-19 crisis could also be experiencing PTSD.
A study in the British Medical Journal compiled earlier this year found 39.5% of staff on critical care wards ‘met the threshold for probable clinical significance’ when surveyed for PTSD symptoms.
The study will also evaluate its impact on patients with neurocognitive impairments resulting from a traumatic brain injury.
Sohail R. Zaidi, Ananda’s president, said: “This is an important milestone for Ananda’s clinical development program, and we look forward to continuing to work with the NYU Grossman School of Medicine.
“We are impressed by the scientific rigour and professionalism of the NYU team in getting a cutting-edge program in place to test the efficacy of our very promising drug.
“The initiation of patient enrolment in this study reinforces our commitment to our goal of improving health and wellness empowered by cannabinoid science.
“This is also an important step in our efforts to provide patients with PTSD with potentially improved therapeutic options.”
This trial is being led by Esther Blessing, assistant professor of psychiatry and Charles R. Marmar, chair of psychiatry.
Dr Marmar leads NYU’s PTSD research programme and is a leading expert in clinical trials for innovative treatments for PTSD and related conditions.
He said: “We are excited to get this important trial underway. Our collaboration with Ananda Scientific allows us to progress in the development of evidence-based CBD products for this debilitating condition.”