References
Mitchell, J. M. et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat. Med. https://doi.org/10.1038/s41591-021-01336-3 (2021).
Colloca, L. & Barsky, A. J. Placebo and nocebo effects. N. Engl. J. Med. 382, 554–561 (2020). 6.
Ashar, Y. K., Chang, L. J. & Wager, T. D. Brain mechanisms of the placebo effect: an affective appraisal account. Annu Rev. Clin. Psychol. 13, 73–98 (2017).
Burke, M. J., Kaptchuk, T. J. & Pascual-Leone, A. Challenges of differential placebo effects in contemporary medicine: the example of brain stimulation. Ann. Neurol. 85, 12–20 (2019).
Feder, A. et al. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry 71, 681–688 (2014).
Mithoefer, M. C. et al. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology 236, 2735–2745 (2019).
Carhart-Harris, R. et al. Trial of psilocybin versus escitalopram for depression. N. Engl. J. Med. 384, 1402–1411 (2021).
Schulz, K. F., Altman, D. G., Moher, D. & Fergusson, D. CONSORT 2010 changes and testing blindness in RCTs. Lancet 375, 1144–1146 (2010).
Colagiuri, B. & Benedetti, F. Testing for blinding is the only way to determine whether a trial is blind. Br. Med. J. 340, c332 (2010).
Olson, J. A., Suissa-Rocheleau, L., Lifshitz, M., Raz, A. & Veissière, S. P. Tripping on nothing: placebo psychedelics and contextual factors. Psychopharmacology 237, 1371–1382 (2020).
Acknowledgements
The content of this article is the opinion of the authors. It does not necessarily represent the official views of the University of Toronto or Harvard Medical School (and their affiliated academic health care centers).
Author information
Authors and Affiliations
Contributions
M. J. B., concept/design, drafting manuscript; D. M. B., concept/design, critical revision of manuscript.
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing interests.
Additional information
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Burke, M.J., Blumberger, D.M. Caution at psychiatry’s psychedelic frontier. Nat Med 27, 1687–1688 (2021). https://doi.org/10.1038/s41591-021-01524-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41591-021-01524-1
- Springer Nature America, Inc.
This article is cited by
-
Therapeutic mechanisms of psychedelics and entactogens
Neuropsychopharmacology (2024)
-
In the new era of psychedelic assisted therapy: A systematic review of study methodology in randomized controlled trials
Psychopharmacology (2024)
-
Probing the antidepressant potential of psilocybin: integrating insight from human research and animal models towards an understanding of neural circuit mechanisms
Psychopharmacology (2023)
-
Validation of a new instrument for assessing attitudes on psychedelics in the general population
Scientific Reports (2022)
-
Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials
Psychopharmacology (2022)