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Human hallucinogen research: guidelines for safety
Open accessAbstract
There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action ('bad trip'), which could lead to potentially dangerous behaviour such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow-up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science.
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“Therapeutic outcomes appear strongly influenced by psychological “set” (mindset, expectations, preparation), environmental “setting,” and structured post-session integration (96, 99, 107, 108), highlighting the central role of context, support, and integration in optimizing benefit.”
From The therapeutic role of self-transcendence in moral injury recovery: theory, mechanisms, and clinical implications (2026) · cites this paper as [96]
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“are not associated with addiction [9, 11, 12]”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [9]
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“individuals with a lifetime history of psychotic or bipolar disorders or with a family history of these conditions in first- or second-degree relatives are currently excluded from participation to prevent the risk of inducing a psychotic or a manic episode in those with these conditions or with a potential genetic vulnerability [9].”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [9]
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“In addition, both antipsychotics and benzodiazepines can reduce the acute effects of psychedelics (Johnson et al., 2008).”
From Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response (2024) · cites this paper as Johnson et al., 2008
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“When implemented with appropriate methodological and ethical safeguards (73, 95, 96), these approaches are associated with improvements in psychological well-being, adaptive reappraisal, and meaning reconstruction (36, 57, 65, 97–99).”
From The therapeutic role of self-transcendence in moral injury recovery: theory, mechanisms, and clinical implications (2026) · cites this paper as [96]
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“These compounds present very low long-term toxicity [9, 10]”
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“The psychedelic experience comes with an increased sensitivity to internal and external stimuli.”
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“It follows that the general context of psychedelic administration fundamentally shapes drug response and hence safety, as well as potentially therapeutic efficacy [9, 88].”
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“Psychedelics generally intensify emotional experience and may give rise to anxiety, dysphoria, fear, panic, or paranoia [9].”
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“This design is based on the contemporary structure of PAP, which typically involves a three-stage framework encompassing preparation, facilitation, and integration (104).”
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“These risks include transient anxiety, panic and, very rarely, prolonged psychosis [42].”
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“Due to the potential of psychedelics to elicit profound psychological and emotional responses, providing empathetic support during and after a psychedelic experience represents a fundamental ethical requirement (84, 89).”
From Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects (2024) · cites this paper as [89]
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“Niacin was used as an active placebo that produces an acute physiological response (flushing) thought to aid in blinding.8,22”
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Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., Cosimano, M. P., & Klinedinst, M. A. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116675513 · Cited by 2,201
“A more detailed description of the study room and procedures followed on session days is provided elsewhere (Griffiths et al., 2006; Johnson et al., 2008).”
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Metadata
- Authors
- Johnson, M., Richards, W., & Griffiths, R.
- Affiliations
- Johns Hopkins University (US)
- Johns Hopkins Bayview Medical Center (US)
- Corresponding author
- Griffiths, RR
- Venue
- Journal of Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2008-05-30
- Volume
- 22
- Issue
- 6
- Pages
- 603-620
- ISSN
- 0269-8811 (ISSN-L)
- 1461-7285
- PMC
- PMC3056407
- OpenAlex
- W2113099805
- Semantic Scholar
- 554f798f25a69d215bea816211ae014c5319edac
- Cited by
- 1,203
- References
- 154
- Citations by year
- 2026: 128 · 2025: 164 · 2024: 167 · 2023: 152 · 2022: 170 · 2021: 97 · 2020: 84 · 2019: 40 · 2018: 42 · 2017: 37 · 2016: 36 · 2015: 21 · 2014: 18 · 2013: 12 · 2012: 12
- FWCI
- 1.32
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- National Institute on Drug Abuse (R01DA003889, R01DA03889)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Neuroscience › Cognitive Neuroscience › Hallucinations in medical conditions
- Keywords
- hallucinogens, psychedelics, bad trips, psychological distress, psychosis, hallucinogen persisting perception disorder, volunteer screening, adverse drug reactions
- MeSH terms
- Clinical Trials as Topic, Environment, Hallucinogens, Humans, Human Experimentation, Perception, Psychotic Disorders, Research, Safety, Practice Guidelines as Topic, Substance-Related Disorders
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