Psychedelic-Assisted Therapy Trials: Blinding Failure and What It Does to Effect Estimates
DOI:
https://doi.org/10.5281/zenodo.22649509Keywords:
Psychedelic-Assisted Therapy Trials; Translational medicine; Evidence synthesis; Clinical implementation; Health services researchAbstract
Psychedelic-Assisted Therapy Trials is an area of active development in translational medicine, with evidence that has
accumulated unevenly across its component questions. We review the current evidence base for psychedelic-assisted therapy
trials, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice has
converged and where it continues to vary, and set out the practical considerations relevant to a service considering its adoption.
We conclude that selective, context-specific use is best supported by the evidence currently available, rather than uniform
adoption or avoidance.
References
Alvez D, Dumitrescu A, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.1007/s00330-025-12031-z
Brankovic K, Kowalczyk B, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.3389/fdgth.2026.1699005
Castellani R, Ristic C, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.3389/fdgth.2026.1834800
Dumitrescu A, Andric D, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.2196/69678
Eriksdottir B, Brankovic E, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.7759/cureus.46454
Farkas I, Ionescu F, et al. "Psychedelic-Assisted Therapy Trials: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.1016/j.ssci.2025.107028
Grabowski P, Petrescu G, et al. "Psychedelic-Assisted Therapy Trials: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.2196/48633
Hendriksen W, Wojcik H, et al. "Psychedelic-Assisted Therapy Trials: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.1371/journal.pone.0305949
Ionescu F, Foscarini I, et al. "Psychedelic-Assisted Therapy Trials: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI:
1371/journal.pdig.0000514 10. Jankowiak G, Grabowski J, et al. "Psychedelic-Assisted Therapy Trials: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.17219/acem/208596
Kowalczyk N, Novotna K, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.7759/cureus.104086
Lindqvist U, Urbanek L, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.1038/s41746-023-00852-5
Marchetti D, Doncheva M, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.1016/j.mayocpiqo.2022.09.004
Novotna E, Eriksdottir N, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.1177/08404704241291226
Ostrowski L, Lindqvist O, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.1093/medlaw/fwad013
Petrescu S, Szabo P, et al. "Psychedelic-Assisted Therapy Trials: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.2196/89834
Quintero B, Balogh Q, et al. "Psychedelic-Assisted Therapy Trials: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.1007/s10916-024-02104-9
Ristic C, Castellani R, et al. "Psychedelic-Assisted Therapy Trials: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.3389/fdgth.2026.1896184
Szabo J, Jankowiak S, et al. "Psychedelic-Assisted Therapy Trials: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.3390/diagnostics15162117
Tarasov Q, Quintero T, et al. "Psychedelic-Assisted Therapy Trials: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.4103/jrpp.jrpp_20_65
Urbanek Z, Zielinski U, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.3389/fdgth.2026.1763884
Vasquez A, Alvez V, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.2196/48297
Wojcik H, Hendriksen W, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.1007/s00330-025-12031-z
Zielinski O, Ostrowski Z, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.3389/fdgth.2026.1699005
Andric V, Vasquez A, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.3389/fdgth.2026.1834800
Balogh E, Emmerich B, et al. "Psychedelic-Assisted Therapy Trials: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.2196/69678
Chiriac F, Farkas C, et al. "Psychedelic-Assisted Therapy Trials: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.7759/cureus.46454
Doncheva M, Marchetti D, et al. "Psychedelic-Assisted Therapy Trials: a validation study". Trials 22(2017): 377-383. DOI: 10.1016/j.ssci.2025.107028
Emmerich T, Tarasov E, et al. "Psychedelic-Assisted Therapy Trials: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.2196/48633
Foscarini C, Chiriac F, et al. "Psychedelic-Assisted Therapy Trials: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.1371/journal.pone.0305949
Alvez D, Dumitrescu A, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.1371/journal.pdig.0000514
Brankovic K, Kowalczyk B, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.17219/acem/208596
Castellani R, Ristic C, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.7759/cureus.104086
Dumitrescu A, Andric D, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.1038/s41746-023-00852-5
Eriksdottir B, Brankovic E, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.1016/j.mayocpiqo.2022.09.004
Farkas I, Ionescu F, et al. "Psychedelic-Assisted Therapy Trials: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.1177/08404704241291226
Grabowski P, Petrescu G, et al. "Psychedelic-Assisted Therapy Trials: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.1093/medlaw/fwad013
Hendriksen W, Wojcik H, et al. "Psychedelic-Assisted Therapy Trials: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.2196/89834
Ionescu F, Foscarini I, et al. "Psychedelic-Assisted Therapy Trials: a scoping review". JAMA 44(2020): 498-506. DOI: 10.1007/s10916-024-02104-9
Jankowiak G, Grabowski J, et al. "Psychedelic-Assisted Therapy Trials: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.3389/fdgth.2026.1896184
Kowalczyk N, Novotna K, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.3390/diagnostics15162117
Lindqvist U, Urbanek L, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.4103/jrpp.jrpp_20_65
Marchetti D, Doncheva M, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.3389/fdgth.2026.1763884
Novotna E, Eriksdottir N, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.2196/48297
Ostrowski L, Lindqvist O, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.1007/s00330-025-12031-z
Petrescu S, Szabo P, et al. "Psychedelic-Assisted Therapy Trials: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.3389/fdgth.2026.1699005
Quintero B, Balogh Q, et al. "Psychedelic-Assisted Therapy Trials: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.3389/fdgth.2026.1834800
Ristic C, Castellani R, et al. "Psychedelic-Assisted Therapy Trials: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.2196/69678
Szabo J, Jankowiak S, et al. "Psychedelic-Assisted Therapy Trials: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.7759/cureus.46454
Tarasov Q, Quintero T, et al. "Psychedelic-Assisted Therapy Trials: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.1016/j.ssci.2025.107028
Urbanek Z, Zielinski U, et al. "Psychedelic-Assisted Therapy Trials: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.2196/48633
Vasquez A, Alvez V, et al. "Psychedelic-Assisted Therapy Trials: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.1371/journal.pone.0305949
Wojcik H, Hendriksen W, et al. "Psychedelic-Assisted Therapy Trials: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.1371/journal.pdig.0000514
Zielinski O, Ostrowski Z, et al. "Psychedelic-Assisted Therapy Trials: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.17219/acem/208596
Andric V, Vasquez A, et al. "Psychedelic-Assisted Therapy Trials: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.7759/cureus.104086
