Microdosing Mushrooms Clinical Trials

What is Microdosing Mushroom?

Mushroom microdosing is a practice in which an individual takes doses of psilocybin mushrooms for which perceptual effects are not apparent. The Food and Drugs Administration first coined the term micro dose for the use of 1% of the active dose of a determined compound in the range of micrograms. In the case of psilocin, the active compound in psilocybin mushrooms, microdoses equate to a range of 5-30 mcg/70 kg of body weight. (1)

The microdosing protocol was described by Dr. James Fadiman as a starting guide for new microdosing users. It consists of a microdose every three days for a week to months. (2)

History

Mushroom intake as part of mystical procedures was common in different antique cultures. Subjects that participated in those practices experienced several effects resulting from the hallucinogenic power of their active compounds.

However, active research on these substances has not been performed until Dr. Albert Hoffman discovered lysergic acid diethylamide (LSD) in 1938, who was initially investigating a new drug for the treatment of postpartum hemorrhage. He was accidentally exposed to a minimum amount of the substance and experienced its hallucinogenic effects.

Later in the 50s, psychedelic drugs were tested to address their potential benefit for treating psychiatric disorders. Although the research techniques used at that time differed from those of contemporary science, investigators found positive results of psychedelics in several psychiatric conditions until their prohibition for research or medical purposes was established in the United States in 1971.

In the last decades, researchers have focused on the potential benefits these drugs pose in treating psychiatric disorders and for many other described uses. (3)

What is the Purpose of Microdosing Mushrooms?

Microdosing Mushrooms Clinical Trials – What is the Purpose of Microdosing Mushrooms?

In the 50s, scientists hypothesized that psychedelics could be used to treat psychiatric conditions such as alcohol-related disorders, anxiety related to life-threatening diseases, depression, and opioid addiction.

Recently, some studies have focused on the potential benefit of microdosing mushroom practices on mood, cognition, and performance in daily life activities.

A study performed by Rootman et al. addressed the motivation of regular users of microdosing with several surveys and found that the majority of responders were motivated to use psilocybin for health and mental-related issues. (4)

The same study depicted that the levels of self-perception of anxiety and depression were lower for those who microdose.

What is the Mechanism of Action of Psilocin?

The exact mechanism of action of psilocin is still under active research. It is believed that psilocin acts on brain serotonin receptors, activating them, a process known as agonism.

Serotonin is a well-studied neurotransmitter involved in several functions such as sleep cycles, mood regulation, metabolism, cognition, and gastrointestinal physiology. Many disorders are associated with dysfunction of serotoninergic pathways, including depression, anxiety, psychotic disorders, bipolar disorders, addictive disorders, Parkinson’s disease, and gastrointestinal issues. (5)

Is it safe?

The safety of medical practices is always a concern to address. Several studies have appraised this question and found that, in general, using these kinds of drugs under the mentioned regimen is safe.

Reports of adverse effects include gastrointestinal symptoms, such as nausea, vomiting, and abdominal discomfort.

In a systematic review of clinical trials, Fuentes et al. found that some studies reported severe adverse reactions such as epileptic seizures and psychotic reactions. (3) However, in those cases, patients had a prior history of such conditions, and it was understood that they resulted from individual predispositions to those disorders.

Seemingly, patients with chronic heart conditions were not involved in the studies mentioned above, as it was hypothesized that exposure to psilocin was unsafe for patients with such disorders.

In Actuality, What are the Clinical Trials on Mushroom Microdosing Investigating?

A search was performed on clinicaltrials.gov for the terms “psilocin.”

The results show nine recruiting and not yet recruiting clinical trials in the US. Four are enrolling or about to enroll healthy individuals to address the effects of several dose regimens, safety, route of administration, and diagnostic imaging changes in the brain during consumption of psilocin.

The rest of the clinical trials will address psychiatric problems such as depression, anxiety, mood changes and disturbances, sleep disturbances, and toxicity. (6)

Summary

Microdosing mushrooms is a technique used primarily for mood and cognitive enhancement. Several clinical trials, to date, have addressed the effects on psychiatric conditions yielding positive effects, especially in alcohol-related disorders.

Although some studies have reported severe adverse reactions such as epileptic seizures and psychotic disorders in predisposed individuals, most have concluded that microdosing mushrooms are usually safe. Several ongoing clinical trials aim to address and clarify missing data about psilocin, its effects, and potential health benefits.

Franco Cuevas, MD

Franco Cuevas is a physician who graduated from the National University of Córdoba, Argentina. He practices general medicine in the Emergency Department at Sanatorio de la Cañada, Córdoba. His focus is on writing medical content to improve physicians' access to relevant medical information for daily practice. He has participated in some research projects and has a special joy in teaching and writing about medical concepts.

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