PharmaDrug Inc announced it has entered into a clinical trial agreement with the Johns Hopkins University (JHU) to conduct a clinical study comparing acute and enduring psychological and neural effects of N,N-Dimethyltryptamine (DMT) and an undisclosed, potently active comparator molecule.
The Toronto-based company said the clinical research collaboration builds upon its existing strategy of focusing on establishing a better understanding of the basic mechanisms by which DMT exerts its effects in the brain and elsewhere in the body.
The principal investigator, Dr Frederick S. Barrett, an associate professor of Psychiatry and Behavioral Sciences, will be supported by co-investigators, Dr Sandeep Nayak and Dr Roland Griffiths, all from the JHU Center for Psychedelic and Consciousness Research.
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"We are excited to collaborate and support Dr Frederick Barrett to better understand DMT and its potential,” CEO Daniel Cohen said in a statement.
“The JHU Center for Psychedelic and Consciousness Research is a global leader in psychedelics clinical research, and we are very grateful to partner with them to achieve our objectives in expanding our pharmaceutical product pipeline for novel uses and delivery forms of DMT to treat unmet medical needs,” he added.
The company said the first part of the planned study will examine the dose effects of DMT and the other test article. In the second part of the study, healthy subjects will be exposed to a maximum tolerated dose of each drug.
During both parts of the study, investigators will carefully characterize any acute and persisting subjective, affective, cognitive, and neural dose-dependent effects for both drugs being evaluated.
PharmaDrug noted that much debate exists around the relative potential benefits of micro vs macro-doses for psychedelic compounds. Using a highly controlled approach, it said the currently planned clinical trial will go some way to finding an answer.
Under the terms of the agreement, the company said it has an exclusive option to obtain a worldwide, royalty-bearing commercialization license to all rights, title, and interest that JHU may have or obtain in any invention that results from the clinical study.
Toronto-based PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs.
Contact the author at stephen.gunnion@proactiveinvestors.com