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Trial Tests Psychedelic Drug Safety, Chemical Activity

Brain hemispheres graphic

(Pixabay)

28 July 2021. A clinical trial is underway that tests an hallucinogenic compound among healthy adults as a potential treatment for mental health disorders. MindMed, in New York, a developer of drugs from psychedelic substances for addiction and mental health conditions, is conducting the study of dimethyltryptamine, or DMT, at University Hospital Basel in Switzerland.

MindMed, short for Mind Medicines Inc., is a two year-old biotechnology company that discovers and develops therapies from psychedelic compounds to treat mental health disorders, including addiction, anxiety, and attention deficit hyperactivity disorder or ADHD in adults. The company is currently testing in clinical trials compounds derived from LSD for anxiety and adult ADHD, and 18-Methoxycoronaridine, or 18-MC to treat opioid withdrawal. The company says its therapies are designed for administration by trained clinicians who supervise dosing and monitor patients during their use of these drugs.

MindMed also collaborates with University Hospital Basel or UHB on discovery of new therapies from psychedelic substances. The new trial is testing DMT, a naturally occurring hallucinogenic chemical derived from vines and leaves in plants found in South America and used by indigenous peoples for centuries. The plant material is boiled into a drink called ayahuasca. A key feature of DMT is its ability to work quickly in the body and for short periods of time, which could make it useful for treating patients in supervised environments.

“DMT as a tool to examine alterations of the mind”

The early-stage clinical trial, according to MindMed, is testing a DMT compound injected intravenously among 30 healthy volunteers recruited at the hospital. Intravenous injections are used to extend the compound’s active lifetime in the body. The study aims to discover the safety and tolerability of DMT at various dosage levels against a placebo, as well as chemical activity in the body. Matthias Liechti, a UHB professor that studies the pharmacology of psychoactive substances and an advisor to MindMed, is leading the study.

The company says it received regulatory authorization for the trial and enrollment has begun. A clinical trial protocol has not yet been listed on ClinicalTrials.gov in the U.S. or the European Union’s trial registry.

“Currently no study has validly determined the elimination half-life of DMT or other pharmacokinetic parameters,” says Miri Halperin Wernli, executive president of MindMed in a company statement, “and our study will provide valuable information for future research on DMT as a tool to examine alterations of the mind. MindMed is exploring a number of psychedelic compounds as part of our mission to discover, develop, and deploy psychedelic-inspired medicines and therapies to address mental illness and addiction.”

Earlier this month, MindMed began a collaboration with Datavant Inc., a health care data analytics company, to collect and track the company’s clinical trial results with aggregated real-world data of patients with mental health disorders. The objective is to better understand treatments, service utilization, and health care experiences of patients outside the controlled environments of clinical trials.

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