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New research has determined that classic psychedelics including psilocybin and LSD are well tolerated in research and clinical settings, with rare adverse events occurring. For their study, the researchers focused on evaluating the severity, frequency and nature of adverse events linked to psilocybin, LSD, 5-MeO-DMT and DMT.
The researchers carried out a meta-analysis and systematic review that studied data obtained from 114 studies that involved more than 3,500 participants. The studies included were drawn from different databases, including Web of Science, PsycINFO, MEDLINE, and Scopus. The research covered studies published up to Feb. 8, 2024. They also had two independent reviewers who screened and selected studies that centered on research or clinical settings where the psychedelics were administered.
Adverse events were classified by type of study population and timescale, with the investigators applying a hybrid approach to include all reported adverse events following the administration of classic psychedelics. In addition, the researchers confirmed the presence of adverse events of special interest such as manic symptoms, suicidality, hallucinogen persisting perception disorder, cardiovascular events and psychotic disorders.
The investigators discovered that nonserious adverse events and serious adverse events that needed psychiatric or medical attention were rare in studies that involved the administration of classic psychedelics in monitored research or clinical settings. They found that only about 4% of participants with pre-existing neuropsychiatric disorders experienced serious adverse events, which included convulsive episodes, suicidal behavior, worsening depression and psychosis.
However, no severe adverse events were reported among healthy participants. Nonserious adverse events such as headaches and paranoia weren’t common either.
In modern research settings, the investigators found no reported cases of persistent psychotic disorders, death by suicide or hallucinogen-persisting perception disorder following the administration of psychedelics.
These findings demonstrate the difference in safety profiles between recreational and clinical settings, with the researchers finding that most catastrophic events reported in recreational use such as suicides and persistent psychotic disorders weren’t observed in trial participants. In their report, the researchers highlighted the need for more thorough pharmacovigilance practices to quantify the benefits and risks of psychedelics accurately.
The researchers also noted that concerns over incomplete adverse events reporting called attention to the need for improved safety monitoring as psychedelics gain more popularity in therapeutic use. Of all the studies evaluated, only 20 studies reported all adverse events and only 16 studies chronicled systematic approaches to adverse-event evaluation.
The research’s findings were reported in “JAMA Psychiatry.”
Researchers involved in the study included Jared T. Hinkle, Marianna Graziosi, Sandeep M. Nayak and David B. Yaden.
Startups in the psychedelics space such as atai Life Sciences N.V. (NASDAQ: ATAI) are likely to analyze the recommendations made by this study in order to glean insights that can enrich their efforts to develop psychedelic drugs that pass the scrutiny of regulators.
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