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Psychedelics (serotonergic hallucinogens) have been used for thousands of years around the world. Their psychoactive effects on perception, mood and cognition have been applied in religious ceremonies and personal healing (1). In the 1960s and 70s, pharmaceutical companies and academic institutions studied the therapeutic potential of psychedelics including psilocybin and lysergic acid diethylamide (LSD). However, by the early 70's a wave of strict prohibition swept through industrialized countries leading to the near cessation of biomedical psychedelics research for a period of almost 50 years. In the last 5 years, there has been renewed interest in the use of psychedelics and a significant acceleration in research activity, leveraging their neuroplastic effect as a novel approach for the treatment of psychiatric disorders. This was coupled with a greater openness of the US Food and Drug Administration (FDA) to research on these substances. Methylenedioxymethamphetamine (MDMA) and synthetic psilocybin-assisted psychotherapy received breakthrough therapy designation in 2017 and 2018, respectively. Esketamine, the S-enantiomer of ketamine, was approved by the FDA for treatment-resistant depression in 2019 (2). As of September 2021, 74 clinical studies are registered on clinicaltrials.gov; the majority studying psilocybin for the treatment of a variety of mental health conditions including depression, post-traumatic stress disorder (PTSD) addiction (3–5), pain and neurodegenerative disorders (6–9).

A number of cities and states in the US have effectively decriminalized psychedelics and in addition to the scientific and clinical attention, psychedelics are increasingly represented in public media and there is some concern that this wave of psychedelic decriminalization is not being accompanied by evidence-based regulation (10).

As compared to opioids, alcohol and tobacco, psychedelics have low addictive potential and benign toxicity profiles (1, 7). There are anecdotal and empirical reports of users experiencing reduced psychological distress and suicidality compared to users of other “recreational or illicit” drugs (11). Psychedelics are included within the broad category “hallucinogens” in the National Survey on Drug Use and Health (NSDUH), which collects lifetime, past-year and past month drug use estimates representative of persons aged 12 and over in each state and the District of Columbia. The most recent survey data indicate a significant increase in hallucinogen use from 4.69 million to 6.01 million between 2015 and 2019. The increase was specific to LSD (60% increase) and a 95% increase in other unspecified hallucinogens, a category that included the entheogens (psychoactive substances historically used for religious or spiritual purposes) such as mescaline and psilocybin, whereas phencyclidine (PCP) and ecstasy use declined over this period (12).

Psilocybin, which is the main psychoactive ingredient in more than 200 species of psychedelic mushrooms (PM) (13), has a particularly benign safety profile and possible positive health effects (14). Alongside the recent increase in information on its promising therapeutic use, the COVID-19 pandemic has considerably increased societal stress, which adds to the propensity to self-medicate as a coping mechanism. This has manifested in the US through an increase in drinking and alcohol related harms (15), increased anxiety, depression, and social isolation among people with substance use disorders (16), and rising addiction rates (17).

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