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First Patient Dosed in Study To Unravel “Mystical Experiences” of Psychedelic Derived From Toad Skin

Abstract psychedelic image of a person and clouds.
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The first participant in a new psychedelic study has received a dose of a synthetic formulation of 5-MeO-DMT. The study is set to evaluate its neurophysiological effects on the human brain and perceived “mystical experiences.”

Unraveling mechanisms behind 5-MeO-DMT’s effect on the brain

5-MeO-DMT – or 5-methoxy-N,N-dimethyltryptamine – is a relative of DMT. It is produced by various plant species and is also secreted from the skin of the Colorado river toad. The toad’s potentially toxic properties even prompted the US National Park Service in a Facebook post to warn visitors that they should “refrain from licking” the amphibian.

The new study will evaluate the effects of a novel synthetic formulation of 5-MeO-DMT – known as BPL-003 – that is taken intranasally. Up to 20 participants will be recruited into the single-blind, placebo-controlled study. The participants will receive both 12 mg of BPL-003 and a placebo on separate visits over a 1-month period.

“It is particularly exciting to begin the dosing phase in this important study. 5-MeO-DMT is among the most potent psychedelics, but its effects on the brain are still not well understood,” explained Tommaso Barba, a PhD student coordinating the study.

“Our research is poised to deliver substantial advancements in our comprehension of these compounds and we hope it will bring further advancements on the link between psychedelics and the dissolution of our usual sense of self,” Barba added.

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BPL-003 – produced by biotechnology company Beckley Psytech – has already been used in other studies evaluating its effects on treatment-resistant depression (TRD) and alcohol use disorder (AUD). However, the researchers in the new study aim to reveal how this 5-MeO-DMT formulation impacts brain activity.

During dosing, the study participants will undergo high-density electroencephalogram scans to measure the brain’s electrical activity, potentially helping to unravel the mechanisms behind the “mystical experiences” and “ego dissolution events” that can occur with psychedelics.

“This study will be the first assessing the effects of 5-MeO-DMT in the human brain and may provide significant advancements in our understanding of consciousness,” said Dr. Christopher Timmermann, head of the DMT Research Group, part of the Centre for Psychedelic Research at Imperial College London.

“5-MeO-DMT is a psychedelic which appears to be particularly effective at inducing states of ego-dissolution and may help us to better understand the relationship between experience, the sense of self and the brain.”

Growing promise for psychiatric conditions

The initial results from trials of BPL-003 for TRD and AUD are promising. A Phase 2a trial for TRD found that 55% of participants experienced an antidepressant response the day after dosing (day 2), and that this effect was sustained – 55% and 45% of patients remained in remission from depression on days 29 and 85.

“Literature suggests an association between intensity of psychedelic experiences and positive treatment effects, so we are keen to explore further and hopefully uncover new insights that we can use to inform our ongoing clinical studies of BPL-003 for treatment resistant depression and alcohol use disorder,” said Dr. Rob Conley, chief scientific and medical officer at Beckley Psytech.

Initial results of the study are expected in 2026.