Results from a systematic review have led to the conclusion that psilocybin is safe to administer in clinical settings, and that there is a need to revise the classification of psilocybin as a Schedule 1 substance.
Researchers at the UK non-profit Drug Science say their systematic analysis “strongly attests” to psilocybin’s safety.
Psilocybin is currently classed as a Schedule 1 under the United Nations Convention on Psychotropic Substances (1971). Any substance classified as a Schedule 1 substance fits the criteria of being highly addictive, having no therapeutic and having a lack of safety for use under medical supervision.
However, psilocybin is currently being administered in clinical settings for research exploring the compound’s efficacy as a therapy for mental health disorders and different addictions, such as nicotine dependence.
More on research from Drug Science: The harms of psychedelics – separating anecdotes and misinformation
The systemic review from Drug Science investigated whether clinical trials of psilocybin support the third category of its Schedule I designation, that “there is a lack of accepted safety for use of the drug or other substance under medical supervision”.
The researchers analysed reports in the PubMed database for “adverse events, drug tolerability, and drug safety” stating that “while nearly all the publications reported behavioural and biological effects of the drug, these findings were not included in this review unless it was clearly stated to be an adverse event or safety risk.”
The results demonstrated that 25 of the 52 publications in the analysis did not contain any reference to adverse events, drug safety, or drug tolerability with 27 publications documenting administration of psilocybin on over 800 occasions to 550 individuals.
The authors state that these 27 publications reported no serious or significant adverse events and positive drug tolerability, suggesting that “psilocybin is safe to administer under proper medical supervision”.
Of the adverse events that were reported, the authors state they were generally considered to be “transient and mild, the most common being headaches”, bar a handful of events that were considered to be more severe. However, the conclusions were that “psilocybin was not responsible for these events”.
The authors state: “The reviewed clinical trials demonstrated rigorous medical and psychological screening processes prior to participant enrollment. All studies excluded participants of vulnerable populations (e.g. history of psychosis), in order to avoid serious adverse events.
“This practice is utilised for medications across all levels of scheduling, in the event that a drug may be safe and effective for certain populations, while having increased rates of adverse effects for others (e.g. one would not administer a beta-blocker to a hypotensive patient).
“The participant selection criteria for many of the reviewed trials required prior experience with psychedelics, further screening out individuals who may be prone to psychedelic-related adverse events.”
They go on to say: “Considerable evidence suggests that psilocybin is generally well-tolerated when administered in a controlled setting. Federally and socially accepted selective serotonin reuptake inhibitors also pose a considerable level of risk, and the acceptable level of risk associated with psilocybin should not serve as a barrier to those whom it could provide positively life-altering outcomes.”
The authors also emphasise the role of set and setting as an important factor in the safe administration of psilocybin.
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