JAMA Psychiatry
September 4, 2024
Marianna Graziosi, Jared T. Hinkle, Sandeep M. Nayak et al.
126 citations
Classic psychedelics such as LSD and psilocybin are generally well tolerated in clinical or research settings, though serious adverse events do occur. In a systematic review and meta-analysis of 214 studies, serious adverse events were reported for no healthy participants and for about 4% of participants with preexisting neuropsychiatric disorders, including worsening depression, suicidal behavior, psychosis, and convulsive episodes. Nonserious adverse events requiring medical intervention, such as paranoia and headache, were rare. In contemporary research, no deaths by suicide, persistent psychotic disorders, or hallucinogen persisting perception disorders were reported after high-dose psychedelic administration. However, the quality of adverse event monitoring and reporting varied significantly across studies.
Frontiers in Psychology
May 23, 2022
David B. Yaden, Dylan Earp, Marianna Graziosi et al.
106 citations
The acute effects of psychedelics depend on users' expectations and surroundings (set and setting). Current clinical psychedelic administration draws on indigenous practices, 1960s new age spirituality, psychodynamic approaches, and cognitive-behavioral therapies. Cognitive-behavioral therapies, including acceptance and commitment therapy (ACT), have the strongest rationale for psychedelic-assisted psychotherapy because they avoid cultural insensitivity, make minimal speculative assumptions about the mind and reality, and have the largest empirical support for safety and effectiveness outside psychedelic therapy. Concepts from CBT, DBT, and ACT can usefully inform preparation, session, and integration phases. Evidence-based psychotherapeutic paradigms provide the best starting point for safety and efficacy.
Psychoactives
April 16, 2024
Daniel Meling, Rebecca Ehrenkranz, Sandeep M. Nayak et al.
26 citations
Psychedelic research has returned after a period of suppression, but media coverage now often overstates benefits as much as it once overstated risks. The actual evidence is more mixed than commonly portrayed, so conclusions about effectiveness remain preliminary. Poor communication may mislead patients and misinform policy. This article reviews studies on psychedelics for depression, noting that effect sizes for other depression treatments—cognitive behavioral therapy, mindfulness, SSRIs, and ketamine—have decreased over time as trials improved. The authors suggest the same may happen for psychedelics: larger, better-controlled trials will likely show smaller, more realistic benefits. Clear communication is essential to set public expectations and guide policy.
Journal of Psychoactive Drugs
September 7, 2023
Marianna Graziosi, Manvir Singh, Sandeep M. Nayak et al.
10 citations
Reports of psychedelic experiences show both similarities and differences across cultural contexts, yet most current characterizations come from Western medical and naturalistic settings. This article reviews the history of diverse psychedelic use in non-Western settings and compares accounts of acute subjective effects within and beyond Western, educated, industrialized, rich, and democratic (WEIRD) contexts. It contrasts themes from direct testimony and psychometric measures including the mystical experiences questionnaire, five-dimensional altered states of consciousness scale, Survey of God Encounters, Survey of Entity Encounters, Challenging Experiences Questionnaire, and Inventory of Nonordinary Experiences. Recommendations are offered for future empirical research to quantify cross-cultural similarities and differences.
Psychedelic Medicine
January 20, 2025
Marianna Graziosi, Gabrielle Agin-Liebes, Mary P Cosimano et al.
9 citations
Psilocybin and other serotonergic psychedelics are used in research settings with safety measures including controlled environments, staff presence, screening, and psychoeducation. An analysis of study materials from psilocybin trials over the past two decades found that psychoeducation documents varied but commonly emphasized biological and physical safety, psychological safety and well-being, aspects of setting, and the potential for expectancies. The materials prioritized biological and psychological safety across all sites. The authors also identified elements unrelated to safety that may contribute to participant expectancies and suggest these extrapharmacological factors be studied systematically to maximize safety while minimizing extraneous expectancies.
PloS one
January 1, 2024
Marianna Graziosi, Julia Sarah Rohde, Stephanie Lake et al.
6 citations
A short-form version of the AWE-S (AWE-SF) was developed and validated within psychedelic samples to measure awe while reducing participant burden. Across five studies, the original six-factor structure was replicated, and the 12-item AWE-SF showed strong associations with positive emotions and openness to experience. It effectively predicted both mystical-type and challenging psychedelic experiences, as well as long-term well-being outcomes like life satisfaction and psychological richness. Connection and vastness facets were linked to positive emotional states and mystical-type experience, while accommodation and self-loss were linked to negative emotional states and challenging psychedelic experience. The AWE-SF is a robust and reliable tool for measuring awe.
AJOB empirical bioethics
July 16, 2025
Katherine Cheung, Caleigh Propes, Marianna Graziosi et al.
4 citations
Informed consent documents from U.S. psilocybin clinical trials often emphasize mental health and physical risks but rarely include psychedelic-specific elements like ineffability or therapeutic touch, despite calls from bioethicists for tailored consent forms. A content analysis of 28 documents from 13 sites found good coder reliability. The results suggest that while general risks are well covered, the unique features of psychedelic experiences are not consistently addressed in consent materials. The authors recommend ongoing debate about which elements are most important for potential participants to consider when deciding whether to join a study.