First-Ever DMT-Assisted Psychotherapy Trial Establishes Safety



The viability of psychedelic compounds as a treatment option for a variety of mental health disorders has been gaining steady momentum for the past decade. While many clinical trials have been conducted in this space, much of the research has been focused on psilocybin, LSD, and ketamine.


Notably absent from this list is DMT (N, N-Dimethyltryptamine); the active ingredient in the ayahuasca. Conducting a clinical study of the ayahuasca brew is considerably more complex since much of the reported positive benefits of the brew for mental health seem to be tied to its ceremonial use making it challenging to accurately assess its effects in clinical settings but how about its active ingredient DMT? A team of scientists at Small Pharma in partnerships with the Imperial College in London recently completed the phase I clinical trial of DMT-assisted psychotherapy; the very first of its kind.


DMT-assisted psychotherapy, if proven effective in future trials, has the potential to become a primary choice for many practitioners mainly due to its considerably shorter synthesis time in the body in comparison with psilocybin or LSD. DMT is metabolized in the body within 20-30 minutes whereas a psilocybin experience can last 6-8 hours and an LSD experience 8-12 hours. A shorter experience means that patients spend considerably less time at the clinics which directly impacts costs, resources, and accessibility.


In an interview with BioSciences Daily, Dr. Routledge, one of the lead researchers of the trial emphasized this point: "One of the reasons we selected DMT (N, N-Dimethyltryptamine) is that it induces a short psychedelic experience but has an expected long-duration antidepressant effect.


“The whole treatment, including wraparound therapy and pharmaceutical dosing for DMT (our patented product is called SPL026), is predicted to be about two hours, whereas for other psychedelic candidates – such as psilocybin – it can take a whole day or more."


The researcher went on to emphasize the importance of talk therapy in combination with the DMT experience: “Together, DMT and talking therapy could enable the increase in new neuronal connections in the brain – triggering a rapid-acting antidepressant effect that provides immediate relief from negative, ruminative thought patterns.” Essentially, the DMT experience appears to function as a pattern disruptor and offers a ripe opportunity to develop new positive neural connections through talk therapy.


The aim of the initial phase was to assess the safety, tolerability, mechanistic and pharmacodynamic effects of DMT with therapy in order to select a suitable dose for phase II of the trial.


In addition to the administration of the patented DMT product, researchers conducted talk therapy sessions before and after the experience to provide psychological safety in preparation and follow-up integrative support to help anchor the experience. There were no adverse effects reported in phase I, “DMT is not anticipated to be addictive or to have abuse liability based on current preclinical and clinical data.” added the lead researcher.


Phase II will be focused on assessing the feasibility of DMT-assisted therapy as an effective treatment option for patients with major depressive disorders. Considering the highly similar molecular structure of psilocin (metabolized psilocybin) and DMT, and the variety of studies demonstrating the high efficacy of psilocybin-assisted therapy for major depressive disorders, the prospects of favorable outcomes for this study are promising.


If phases II and III of the trials demonstrate clinically significant positive outcomes, DMT-assisted psychotherapy can be expected to reach UK and US populations by 2026-2027.




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