ATMA Clinical Trials | Evaluating safety and efficacy

Evaluating safety and efficacy of psychedelics

ATMA is a forward-thinking psychedelic training and healthcare company actively engaged in research initiatives focused on the therapeutic use of psilocybin and MDMA for mental health disorders like PTSD, depression, and anxiety. Inspired by the promising results of research emerging from institutions like King’s College and Johns Hopkins University, ATMA is dedicated to advancing the understanding of these medicines, as well as contributing to the growing evidence base that demonstrates the efficacy of psychedelic-assisted therapy. Our mission is to pioneer innovative treatment options and be a leader in mental health interventions, inspired by success stories emerging from the medical community.

Current Trials

Phase II Psilocybin Clinical Trial

A Phase II Study Assessing the Efficacy of Psilocybin-assisted Therapy when Administered to Frontline Mental Healthcare Workers Suffering from Major Depressive Disorder Related to COVID-19

This trial will evaluate the potential of psilocybin-assisted therapy in treating Major Depressive Disorder (MDD) when administered to frontline mental healthcare professionals in either a group or individual treatment setting.
While a considerable portion of the Canadian population continues to struggle with mental distress stemming from the repercussions of COVID-19, healthcare professionals themselves have faced significant mental hurdles. Despite the immense physical and psychological burdens imposed by the pandemic, many mental healthcare professionals have prioritized the well-being of their patients over their own, resulting in an unaddressed need for mental support.

Who is eligible to participate?

Inclusion and exclusion criteria are required in all clinical trials, by selecting individuals who meet specific study-related eligibility criteria in order to ensure participant safety, scientific validity, and minimize confounding factors, thus generating reliable and meaningful data.

Why is ATMA is exploring a group administration protocol?

Frontline workers struggling with depression can find solace and support in connecting with peers who share similar experiences, fostering empathy and collaborative behaviors.
ATMA is developing a group administration protocol despite limited published research on the efficacy of psychedelic therapy in a group setting. However, ample evidence in the psychology field suggests that individuals struggling with depression often lack connections to others and community. Therefore, psychedelic therapy in group settings may induce states of communitas, defined as a transient dissolution of power dynamics and social structure. Such states have been demonstrated to mediate increases in social connectedness and well-being.
Follow-up group integration sessions may induce a sense of psychological safety. Bringing together individuals who have undergone a consciousness-changing experience and inviting them to openly share about their experiences can evoke social heart coherence—a harmonious state of interconnectedness. Additionally, promoting empathy and cooperation can support the process of psychological integration and self-regulation.

ATMA Phase II Psilocybin-assisted
Therapy Clinical Trial Application

Keep an eye on this page for updates on the opening dates of the application process. We will also notify you via email and social media once the application period becomes available.

Study Schematic

Screening &
Enrollment

In-Person Screening

Initial Screening
Form

Screening

Medical/Psychiatric,
etc.

Treatment
Period

Preparatory Session

Pre-dosing check-in with research and therapy staff

Treatment Session

Day of psilocybin administration
(group setting or private setting)

Integration Session

Group or individual
therapy

Follow Up
Period

Video/Phone Follow Up

2 days post medicine
session

Video/Phone Follow Up

7 days post medicine
session

Video/Phone Follow Up

5 weeks post medicine
session

In-Person Follow Up

12 weeks post
medicine session

Video/Phone Follow Up

12 months post
medicine session

Past Trial

Phase I Psilocybin Clinical Trial

A Phase I Study with the intent to assess the safety of psilocybin when administered to healthy participants. This clinical trial for psilocybin-assisted therapy evaluated the safety and tolerability of psilocybin in the healthcare practitioners.

ATMA’s first clinical trial

This was ATMA’s first clinical trial, approved to evaluate 14 healthy healthcare practitioners. As psilocybin-assisted therapy nears legalization, there is the ever- growing need for healthcare practitioners to understand the psychedelic state thoroughly and completely, which is only achievable via firsthand experience. This firsthand experience allowed for practitioners to gain comprehensive insights into the medicine they will eventually be administering to their patients. The primary objective of this trial was to demonstrate the safety and tolerability of psilocybin in these healthy healthcare practitioners. In order to be considered for this study, participants were required to be in good mental and physical health as assessed by a physician. The secondary exploratory objective was to evaluate the general nature of the subjective effects occasioned by the consumption of psilocybin, via standardized self-assessment questionnaires (the Quick Inventory of Depressive Symptomatology Self-Report 16 – QIDS-SR16, and the Revised Mystical Experience Questionnaire – MEQ-30).