🎉 Health Canada Provides a No Objection Letter for ATMA’s N500 Phase II Clinical Trial Application

Clinical trials are the standard way to evaluate the safety and efficacy of new drugs (including psychedelic drugs) for medical use. Clinical trials also serve to test novel treatment options, explore ways to improve quality of life for people living with illnesses or diseases, and assess whether a new drug or treatment has fewer side effects than existing treatment options.

In Canada, the Clinical Trial Application (CTA) is broken down into 3 modules:

  • Module 1 – contains administrative and clinical information about the proposed trial
  • Module 2 – contains quality (chemistry and manufacturing) information about the drug product(s) to be used in the proposed trial
  • Module 3 – contains additional supporting quality information

These modules are broken down into a detailed list of requirements on the Canadian government’s website. For more information regarding these requirements, click here.

Clinical trials consist of four phases. In terms of psychedelic drugs:

  • Phase I – demonstrates the safety of the psychedelic drug, including safe dosage range, as well as monitoring for adverse events. This is typically done with a small group of healthy participants.
  • Phase II – examines the efficacy of the psychedelic drug in treating a disease or condition. This is a larger phase that usually consists of 100+ participants, in order to examine its effect in a wider range of people. Dosing is also examined during this stage.
  • Phase III – monitors side effects of the drug, compares the drug to existing treatments for the same condition, and collects data that will allow for the drug’s safe use on the market. This phase typically consists of 1000+ participants, which helps to ensure it is still effective with a larger population.
  • Phase IV – takes place after the psychedelic is approved for the market. This phase is also known as ‘post-marketing surveillance,’ and gathers data from the drug’s use in the general public, including long-term risks and benefits and best practices.

This is an extensive a process, often taking a substantial amount of time and resources to complete each phase. For governments approving new drugs, treatments, and medical devices, etc., it is understandable as to why such a process exists; public safety is the number one priority.

The data collected from clinical trials is the only data that Health Canada accepts as evidence of a valid new treatment. However, regarding psychedelics, this is a bit of a setback, as solid research has been conducted globally since the 1950s. Much of this research was funded by the US government through grants in the 1970s!

How do you participate in a clinical trial?

Health Canada has a database of clinical trials that shares what trials are available, what substances are being studied, and the indication for which the trial is being conducted. Of note, while Health Canada highly recommends that sponsors list their clinical trials in this database, it is not mandatory, hence not all trials will be included.

We recommend visiting ClinicalTrials.gov, as this is where clinical trials happening worldwide are listed. Here you will find details regarding each clinical trial, including the recruiting status, how to participate, whether the trial is active or complete, and where to view the study results. Inclusion and exclusion criteria are also listed, as each trial has specific eligibility requirements for its participants, including how many participants are being accepted. For example, if you applied for an N20 clinical trial, there are 20 spots available. Through this vetting process, there are often age requirements and population requirements (e.g., a healthy individual vs. having a specific condition).

Whether or not you plan on participating in a clinical trial, we highly recommend visiting the clinical trial database and reviewing the psychedelic trials for psilocybin, LSD, and MDMA at a minimum. At the time of writing, this there are 345 clinical trials for psychotropic substances, 99 of which are for psilocybin (the active ingredient in magic mushrooms).

As some of you may know, ATMA has been approved for a Phase I N20 safety clinical trial examining healthy individuals aged between 18 – 65. This trial is aimed at healthcare professionals, allowing for them to experience psilocybin in a unique way, giving them a better understanding of what their patients may undergo once this therapy is legalized.

The 20 participants for this trial have already been chosen; we have moved to the second stage of the vetting process to confirm that these individuals are healthy. ATMA’s clinical trial will be completed by the end of August 2022, with the results coming out in the fourth quarter of 2022.

ATMA has recently applied for a second clinical trial that will range between 150 – 500 participants. This Phase II trial will examine the efficacy of psilocybin in frontline healthcare professionals who have been impacted by COVID-19-related mental health conditions.

In order to participate in any of ATMA’s clinical trials, you must have taken ATMA’s Introduction to Psychedelic-assisted Therapy Training Program or an equivalent.

If you have not taken ATMA’s Introduction to Psychedelic-assisted Therapy Training Program but would like to see if it is a good fit for you, please book a call with us.

Go to ATMA Academy for information about our training programs, experiential training, and clinical trials.

Thank you,

The ATMA Academy Team

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