A Canadian-based pharmaceutical company has received approval to conduct a clinical study of the psychedelic compound DMT as a treatment for stroke. Under the plan, pharmaceutical development company Algernon Pharmaceuticals will study an intravenous formulation of DMT as a treatment for stroke in the Netherlands, with the first participants receiving the drug in the fourth quarter of 2022.
Dr. David Nutt, professor of neuropsychopharmacology at Imperial College London and a consultant for Algernon, said the use of DMT is a new approach to treating patients who have suffered a stroke.
“Hundreds of drugs have failed in the stroke treatment space, and nearly all of them have focused on the same strategy: a delayed attempt at neuroprotection,” Nutt told Psychedelic Spotlight.
“Algernon’s approach with DMT is to bolster the brain’s natural recovery by enhancing neuroplasticity to facilitate the creation of new neural networks,” he added. “This is something completely different than what has been tried before.”
Stroke is a brain injury that is usually caused by a blood clot or other blockage of blood vessels in the brain, resulting in a loss or reduction of blood flow that prevents oxygen and nutrients from getting to brain tissue. Stroke is the fifth leading cause of death in the United States, taking the life of someone every four minutes. Stroke is also the leading cause of long-term disability among Americans, according to information from the United Brain Association. Someone in the U.S. has a stroke every 40 minutes, for a total of nearly 800,000 strokes every year.
Stroke can cause brain cells to die due to lack of oxygen. A stroke can also cause other damage including neuroinflammation from reperfusion, which is tissue damage to brain cells caused when blood flow is restored. Currently, there are no conventional medical therapies that are highly effective at addressing reperfusion injury in stroke patients.
DMT Is a Natural Psychedelic Drug
N,N-dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug similar to LSD or psilocybin, although with effects that are usually short-lived but very intense and vivid. Humans produce an endogenous form of the drug, and it can also be found in several species of plants and animals.
Previous research has shown that DMT may have unique benefits for treating stroke patients. The drug can provide protective effects after reperfusion injury and help stimulate new cell growth. DMT has also been shown to improve neuroplasticity, the ability of the brain to form and restructure synaptic connections in response to learning or experience or after an injury.
“In a rat stroke occlusion study, rats given DMT showed reduction in the area of brain damage from the stroke and had almost a full recovery of motor function when compared to control,” said Algernon CEO Christopher Moreau. “In a preclinical research study at UC Davis, DMT increased neuroplasticity in a cortical neuron growth assay.”
Moreau believes that DMT represents a novel way to promote healing and recovery after an ischemic stroke.
“For 85% of patients suffering an ischemic stroke, which constitute 85% of all strokes, there are no treatment options,” said Moreau. “Hundreds of stroke drugs have failed in the clinic but have been focused on neuroprotective measures, whereas DMT represents a different approach to stroke treatment, helping with healing after the injury occurs.”
Algernon’s study will begin later this year to research the safety and tolerability of DMT among 60 test subjects, including participants with and without experience with psychedelic drugs. While other studies have shown DMT to be safe and well-tolerated, the study is unique because it involves prolonged infusions of non-psychedelic doses of the drug for durations longer than previously studied. Moreau explained that the fastest way to deliver a drug and maximize the dose is through a single injection over a short period of time or a “long duration intravenous delivery method because it bypasses the stomach and liver.
“Algernon will be delivering a sub-psychedelic dose to patients over a range of multiple time periods,” he said. “This approach has never been done before in a Phase I trial.”
The initial part of the study will use a single-escalating dose design to determine a safe, tolerable dose that will not produce psychedelic effects. The second part of the research will study the effects of repeated, prolonged administrations at the determined dose. Algernon will use the data generated by the research to develop a Phase 2 clinical trial that will test the DMT infusion on acute and recovering stroke patients.
Algernon received approval to conduct the research from Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent Medical Research Ethics Committee (“MREC”). The trial will be conducted at the Centre for Human Drug Research in the city of Leiden in the Netherlands.
“I was drawn to DMT’s endogenous nature and possible role in naturally occurring altered states of consciousness such as dreams and psychosis, as well as being a prototype for other psychedelic drugs in common use,” Algernon consultant Rick Strassman MD, a psychiatrist and psychopharmacologist and the author of the book DMT: The Spirit Molecule, said in a statement from the company. “Our careful assessment of psychedelic and non-psychedelic doses of DMT established guidelines for studies utilizing its neuroplastogenic effects in stroke, an application I would not have predicted at the time. These more recent findings of DMT’s effects have opened an extraordinarily promising set of potential therapeutic applications for Algernon to explore.”
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