Canada-based ATMA Journey Centers has submitted a new trial application to Health Canada to investigate 3,4-Methylenedioxymethamphetamine (MDMA) in healthcare workers with mental health issues. ATMA is a psychedelic-assisted therapy training provider.
The clinical trial will enrol frontline healthcare workers with documented mental health issues. Participants will have to self-assess the psychological assessment before and after the treatment to evaluate MDMA’s efficacy as a therapeutic agent.
In addition, ATMA will collect feedback from the participants on MDMA’s potential clinical utility. The trial will also look at the experience of observing other participants who were administered MDMA as a tertiary outcome. This has the potential to help healthcare workers to understand the benefits of MDMA-assisted therapy in a legal clinical setting.
The MDMA trial will be similar to ATMA’s Phase II trial investigating psilocybin, a naturally occurring hallucinogenic chemical found in certain mushrooms known as magic mushrooms. The psilocybin trial was greenlighted by Health Canada in September 2022. The aim of the study is to investigate the potential relief of Covid-19-related mental health concerns in healthcare providers, as well as evaluating clinical utility from the provider’s perspective.
ATMA is still waiting for approval from the Health Research Ethics Board of Alberta (HREBA), but the study is anticipated to begin in the summer of 2023.
ATMA founder Vu Tran said: “As psychedelic-assisted therapy nears legal status globally, Health Canada will be seen by the world as a progressive leader in psychedelic medicines, for making these types of clinical trials available to healthcare professionals who are training in this field.”
Last December, Health Canada released a notice on its expectations regarding risk-management measures for clinical trials that are investigating psychedelic-assisted psychotherapy. Meanwhile, the US FDA is yet to release a draft guidance on the considerations for scientific investigations that involve psychedelic drugs.
In January 2023, Health Canada approved a psychedelic clinical trial with a unique twist. Diamond Therapeutics will give Phase II trial participants take-home low doses of psilocybin. The four-week trial is expected to begin in late 2023 or early 2024, enrolling 40 patients with generalised anxiety disorder.
Earlier this month, MAPS reported positive topline results from a Phase III follow-up trial investigating the long-term efficacy and safety of MDMA-assisted therapy in patients with post-traumatic stress disorder (PTSD).
While researchers release more and more data from clinical trials, some say that psychedelic drugs are yet to prove their value. High expectations from the media and the public may add to execution challenges in running these trials.