PharmaDrug Inc. is to carry out a clinical study with The Johns Hopkins University investigating DMT.
Speciality pharmaceutical company PharmaDrug Inc. has entered into a Clinical Trial Agreement with The Johns Hopkins University to conduct a clinical study that will compare the acute and enduring psychological and neural effects of N,N-Dimethyltryptamine (DMT) and an undisclosed, potently active comparator molecule.
Could expectancy contribute to clinical outcomes?
PharmaDrug says that the mind-altering effects of drugs such as DMT are well known, and that a study participant’s expectancy may contribute to clinical outcomes which could lead to misinterpretation of efficacy signals.
Such a phenomenon was recently noted in a placebo-controlled study of LSD, which found that those receiving either LSD or placebo showed significant improvements in mood, anxiety, creativity and energy.
To address this common study limitation and in order to assess the neuropsychiatric impact of DMT, PharmaDrug has sponsored the submission of an Investigational New Drug application to the FDA, which aims to compare the effects of DMT with another potently psychotropic drug.
The principal investigator, Dr Frederick S. Barrett, PhD, 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.
PharmaDrug CEO, Daniel Cohen, said: “We are excited to collaborate and support Dr Frederick Barrett to better understand DMT and its potential.
“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.”
The first part of the study will examine dose effects of DMT and the undisclosed drug and the second part will expose healthy subjects to a maximum tolerated dose of each drug. Investigators will characterise acute and persisting subjective, affective, cognitive, and neural dose-dependent effects for both drugs being evaluated and aims to answer the questions of the potential benefits of micro vs macro-doses for psychedelic compounds. Using a highly controlled approach, the currently planned clinical trial will go some way to answering this important question.
The Johns Hopkins researchers aim to develop a deeper understanding of how DMT acts in the brain of healthy volunteers by employing psychological assessment tools with state-of-the-art functional MRI and EEG.
