“When the doors of perception are cleansed, men will see things as they truly are, infinite.” Those words are from the 18th century religious poet William Blake. The writer Aldous Huxley used that phrase for his autobiographical book about psychedelic experimentation, “The Doors of Perception” (1954). And of course, the 1960s psychedelic rock group “The Doors” took the words and the sentiment for their name.

On June 23, the U.S. Food and Drug Administration (FDA) threw those doors wide open for the medical establishment. In a groundbreaking move, the FDA unveiled comprehensive guidelines for conducting clinical trials on psychedelic substances.

This development paves the way for the integration of substances such as psilocybin (the psychoactive ingredient in “magic mushrooms”) and lysergic acid diethylamide (LSD) into mainstream behavioral health treatments. Where conventional drug treatments have failed, psychedelics are proving effective in treating a range of ailments, including depression, anxiety, chronic pain, and post-traumatic stress disorder.

Federal prohibition of psychedelic substances makes it difficult to study their benefits, requiring researchers to jump through bureaucratic hoops. Companies engaged in the development of psychedelic drugs cheered the regulatory clarity provided by the FDA’s new guidance.

As the following infographic shows, a lot of money is at stake:

Source: The Business Research Company

Psychedelics are a major focus of medical research around the world, giving birth to a new industry that’s rife with investment possibilities. Pharmaceutical companies are forming, most of them clinical stage micro-caps. Big Pharma is jumping into the fray as well.

After years of concerns surrounding the recreational use and associated risks of psychedelic products, these substances are now gaining widespread acceptance and emerging into a multi-billion-dollar industry. That said, much of the research has been stymied, because psychedelics remain banned in many countries. In the U.S., they are restricted at the federal level as a Schedule I substance.

The FDA’s inaugural draft guidance outlines various considerations for researchers exploring the therapeutic potential of psychedelics.

The 14-page document addresses important aspects such as trial conduct, data collection, and subject safety. The FDA’s release of the guidance closely follows the introduction of bipartisan legislation in Congress that calls for the creation of clinical trial guidelines.

Mile High gathering…

The FDA’s announcement last Friday coincided with a significant event, called Psychedelic Science 2023, held in Denver from June 19-23, where approximately 10,000 attendees and numerous exhibitors gathered. The confab in the Mile High City billed itself as the “largest psychedelic conference in history.”

The FDA’s guidance primarily covers studies involving “classic psychedelics” such as psilocybin, LSD, and newer synthetic substances such as methylenedioxymethamphetamine (MDMA, aka “Ecstasy”). These substances have shown promise in addressing various addictions and mental health disorders. Psychedelics have shown promise in weaning patients away from alcohol, nicotine, and opioids.

The FDA aims to assist researchers in designing studies that yield empirical results capable of supporting future drug applications. The guidance emphasizes the examination of potential drug interactions with substances such as antidepressants or lithium.

If the FDA were to approve a product based on psychedelics, it would recommend reclassifying the drug outside of Schedule I for its authorized use.

Read This Story: LSD: From Nixon’s War on Drugs to Big Business

After historic legalization victories in California, Colorado, and Oregon, the campaign to expand public access to psychedelic drugs is now moving to additional states in 2023. A statistical model recently published in the Journal of American Medicine (JAMA) predicts that most states will allow access to psychedelics over the next 10-15 years.

Psychedelics are shedding their countercultural baggage and becoming respectable. These drugs have evolved from revelers at Whisky a Go Go, to technicians in lab coats. The psychedelics industry’s growth is accelerating, with companies involved in marijuana and related psychotropic substances poised to reap huge gains.

Many publicly traded marijuana companies are expanding into psychedelics research. Some of these companies are good investments; others are not. You must conduct due diligence.

That’s where my publication, Marijuana Profit Alert, comes in. By applying my proprietary screening methodologies, I pinpoint for subscribers the most attractive plays on the psychotropic revolution. To learn more, click here.

John Persinos is the chief investment strategist of Marijuana Profit Alert.

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