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Cited by 88Psychedelics and Drug StudiesReligion, Spirituality, and PsychologyPain Management and Placebo Effect

Assessing the risk–benefit profile of classical psychedelics: a clinical review of second-wave psychedelic research

Bender, David, Hellerstein, David J.·2022·Psychopharmacology
DOI 10.1007/s00213-021-06049-6
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Abstract

Rationale A broad reassessment of the potential benefits of psychedelic drugs has led to the initiation of multiple major clinical trials in an effort to advance their status to become FDA-approved medications, as well as local legislative efforts to legalize or decriminalize their use.Objectives To use recently published data to assess potential risks and benefits of psychedelic drugs as therapeutics, as well as to synthesize what is currently known in order to generate fruitful future research directions.Methods A review of studies conducted since 1991 identified 14 clinical trials of classical psychedelics, including 11 of psilocybin (N = 257 participants), 1 of lysergic acid diethylamide (N = 12 participants), and 2 of ayahuasca (N = 46 participants). Other published studies (e.g., of healthy volunteers, survey studies, case reports, neuroimaging) were also considered for review.Results Published studies since 1991 largely support the hypothesis that small numbers of treatments with psychedelic-assisted psychotherapy can offer significant and sustained alleviation to symptoms of multiple psychiatric conditions. No serious adverse events attributed to psychedelic therapy have been reported. Existing studies have several limitations, including small sample sizes, inherent difficulty in blinding, relatively limited follow-up, and highly screened treatment populations.Conclusions Substantial data have been gathered in the past 30 years suggesting that psychedelics are a potent treatment for a variety of common psychiatric conditions, though the ideal means of employing these substances to minimize adverse events and maximize therapeutic effects remains controversial. Unique factors related to study design are vital for clinical researchers in the field to address.

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Authors
Bender, D., & Hellerstein, D. J.
Affiliations
  • Washington University in St. Louis (US)
  • New York State Psychiatric Institute (US)
Corresponding author
Hellerstein, David J.
ORCID
Hellerstein, David J.
Venue
Psychopharmacology
Publisher
Springer Science and Business Media LLC
Published
2022-01-13
Volume
239
Issue
6
Pages
1907-1932
ISSN
  • 0033-3158 (ISSN-L)
  • 1432-2072
DOI
10.1007/s00213-021-06049-6
OpenAlex
W4206268123
Cited by
88
References
118
Citations by year
2026: 14 · 2025: 12 · 2024: 24 · 2023: 21 · 2022: 17
FWCI
3.13
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Social Sciences › Health › Religion, Spirituality, and Psychology
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Keywords
classical psychedelics, psychedelic-assisted psychotherapy, psilocybin, LSD, ayahuasca, risk-benefit profile, mental illness, adverse events, psychedelic therapy, clinical trial design
MeSH terms
Hallucinogens, Humans, Lysergic Acid Diethylamide, Psilocybin, Risk Assessment, Banisteriopsis

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