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New Clinical Trial Explores Safety of DMT for Substance Use Disorders

New Clinical Trial Explores Safety of DMT for Substance Use Disorders content piece image
The flower of Psychotria viridis, a natural source of DMT. Credit: A.Benedito, CC BY-SA 4.0 <https://creativecommons.org/licenses/by-sa/4.0>, via Wikimedia Commons
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Substance use disorders have a debilitating impact on the wellbeing of individuals and their families. Like many other mental health disorders, these conditions have proved stubbornly resistant to treatment. The potential of psychedelic compounds to treat substance use disorders has led Canadian R&D company Entheon Biomedical to investigate the therapeutic use of the psychedelic dimethyltryptamine (DMT). The company has commissioned a clinical trial investigating the safety and efficacy of intravenous DMT. Technology Networks spoke to Entheon’s CEO, Timothy Ko, to find out more.

Ruairi Mackenzie (RM): What will be involved in the first stage of your DMT clinical trial? 

Timothy Ko (TK):
We have a clinical study agreement in place with a contract research organization, the Centre for Human Drug Research (CHDR) located in Leiden, Netherlands, to conduct an early phase clinical trial with DMT on humans. The objective of the study is to evaluate the safety of DMT in humans and, specifically, we’re looking to better understand the pharmacodynamics and pharmacokinetics of DMT when administered intravenously.

This will be a data-centric clinical trial, gathering vital information on the biochemical and physiological changes that occur when DMT is administered. This trial will give us further insight into the drug’s effects on the central nervous system and its impact on subjective experience, providing not only pharmacokinetic/pharmacodynamic but also a host of other valuable biometric data. All of this is critical to properly understand DMT’s potential as part of a therapeutic protocol to treat substance use disorders. 

RM: What do you see as the unique challenges in treating substance abuse disorders in comparison to other mental health disorders?

The success rates of current treatments and interventions are dismal, and as a society, we have become conditioned to accept these low rates of success as a foregone conclusion. We want to turn those assumptions upside down - to invert the addiction-recovery ratio and we believe we can do it through the development of a DMT-based therapeutic protocol.

Substance-use disorder is obviously a very complicated situation for both the individual grappling with it and for a society and public health system that is tasked with addressing and remedying the devastating effects and widespread damage that stems from unchecked substance-use disorder. With no straightforward solution present, our belief is that a medicalized, psychedelic-assisted therapy model provide a powerful tool for substance-use sufferers to gain the clarity and support required to reclaim their lives. 

RM: How is DMT well placed to meet those challenges?

Through extensive talks with our scientific advisors, a review of the literature and historical studies, DMT emerged as our ideal candidate for addiction treatment. DMT belongs to a class of psychedelic compounds, including psilocybin and LSD, which have shown high therapeutic value, and it is the psychoactive ingredient in ayahuasca. Being endogenous to the human body, DMT can be found in many plant species, and throughout its research history DMT has demonstrated a strong safety and toxicology profile. In addition, DMT is rapidly metabolized, so it is well-suited for a shorter, more tailored therapy experience, which has the added benefit of decreased costs and increased scalability. The ability to maintain a flexible and short therapy duration provides an element of control that cannot presently be achieved with other longer-lasting psychedelics. DMT is short-acting, powerful and has demonstrated safety in humans. These are the core reasons why we chose to focus our efforts on DMT.

RM: Do you believe that DMT will prove efficacious for all substance use disorders, or will it treat certain disorders more effectively? 

Our initial target indications will be nicotine addiction, alcohol-dependency and opioid use disorder. That being said, our DMT-assisted therapeutic protocol is being designed to address the core mechanisms underlying drug-seeking and using behaviour. Understanding that these drug-seeking behaviours are generated from a complex psychological and emotional place, DMT holds promise to directly address this base state, from which all manner of substance-use disorders are thought to originate from. From this standpoint, our aim is to prove efficacy for the initial target indication and then expand to focus on additional indications and substance-use disorders.

RM: What is the timeline for your DMT trial? How soon do you believe psychedelic-based therapeutics could be widely available?

Recognizing the potential constraints of the ongoing coronavirus pandemic, we currently anticipate that our clinical trial at CHDR will commence in Q3 of 2021. We are doing everything we need logistically to ensure our trial remains on track.

Recently we announced our DMT drug-supply agreement with Psygen Labs, and that they have successfully completed production of our DMT research batch. This represents a major step in our clinical pathway, as the commencement of clinical trials and preparation hinges on having a consistent and high-quality drug supply. Once all necessary permits and licenses are in place, our drug-supply will be shipped to CHDR for requisite testing and formulation.

We are proving the safety and efficacy of our treatment protocol through standard regulatory channels that traditional drug developers go through - the FDA, EMA, and Health Canada. We expect that given our current trajectory, we would like to be in the final stages of clinical development and ready to seek final approvals and pursue commercialization in 4-5 years. But really, given the pressing need for effective treatments, paired with the growing loss of life from overdose, and the significant social and economic impact of substance-use disorders, an effective and scientifically validated solution cannot come quickly enough.

Timothy Ko was speaking to Ruairi J Mackenzie, Science Writer for Technology Networks