{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:26:40Z","timestamp":1791505600222,"version":"4.3.4"},"reference-count":83,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2024,7,31]],"date-time":"2024-07-31T00:00:00Z","timestamp":1722384000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811241265756","type":"journal-article","created":{"date-parts":[[2024,7,31]],"date-time":"2024-07-31T05:59:46Z","timestamp":1722405586000},"page":"690-700","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":36,"title":["A framework for assessment of adverse events occurring in psychedelic-assisted therapies"],"prefix":"10.1177","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0415-6411","authenticated-orcid":false,"given":"Roman","family":"Palitsky","sequence":"first","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deanna M","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"},{"name":"Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Perna","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary","family":"Bosshardt","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4768-7332","authenticated-orcid":false,"given":"Jessica L","family":"Maples-Keller","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly F","family":"Levin-Aspenson","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of North Texas, Denton, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali John","family":"Zarrabi","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"},{"name":"Division of Palliative Medicine, Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Peacock","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"},{"name":"Winship Cancer Institute, Emory University, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Mletzko","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara O","family":"Rothbaum","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6687-0066","authenticated-orcid":false,"given":"Charles L","family":"Raison","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George H","family":"Grant","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Emory Spiritual Health, Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4653-0483","authenticated-orcid":false,"given":"Boadie W","family":"Dunlop","sequence":"additional","affiliation":[{"name":"Emory Center for Psychedelics and Spirituality, Emory University, Atlanta, GA, USA"},{"name":"Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,7,31]]},"reference":[{"key":"bibr1-02698811241265756","first-page":"345","volume":"3","author":"Abruzzi W","year":"1974","journal-title":"Contemp Drug Probl"},{"key":"bibr2-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-015-1163-8"},{"key":"bibr3-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.neubiorev.2020.03.017"},{"key":"bibr4-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1021\/acsptsci.1c00014"},{"key":"bibr5-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/a0038601"},{"key":"bibr6-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.22010073"},{"key":"bibr7-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/0269881116678781"},{"key":"bibr8-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/0735-7028.34.5.508"},{"key":"bibr9-02698811241265756","doi-asserted-by":"publisher","DOI":"10.31234\/osf.io\/gmpfa"},{"key":"bibr10-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/02698811221116926"},{"key":"bibr11-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-023-41145-x"},{"key":"bibr12-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/2167702621996340"},{"key":"bibr13-02698811241265756","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199920020-00002"},{"key":"bibr14-02698811241265756","first-page":"265","volume":"43","author":"Butterfield LD","year":"2009","journal-title":"Canad J Counsel"},{"key":"bibr15-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.brainresbull.2016.04.016"},{"key":"bibr16-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1007\/s00213-014-3714-z"},{"key":"bibr17-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1080\/10508619.2022.2148061"},{"key":"bibr18-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-031-14332-8_16"},{"key":"bibr19-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2022.2079108"},{"key":"bibr20-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/a0017299"},{"key":"bibr21-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02799-9"},{"key":"bibr22-02698811241265756","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.4505228"},{"key":"bibr23-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/a0036465"},{"key":"bibr24-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1093\/med-psych\/9780190926939.001.0001"},{"key":"bibr25-02698811241265756","unstructured":"Food and Drug Administration (2010) IND Safety Reporting, 21 C. F. r. \u00a7 312.32. Available at: https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-D\/part-312"},{"key":"bibr26-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugpo.2020.102997"},{"key":"bibr27-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/0959354315619708"},{"key":"bibr28-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2206443"},{"key":"bibr29-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.20221043"},{"key":"bibr30-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/1363461520983684"},{"key":"bibr31-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/0269881116677852"},{"key":"bibr32-02698811241265756","first-page":"12","author":"Hartogsohn I","year":"2018","journal-title":"Front Neurosci"},{"key":"bibr33-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2022.2125467"},{"key":"bibr34-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/pst0000359"},{"key":"bibr35-02698811241265756","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2022.917199"},{"key":"bibr36-02698811241265756","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.2-98.v1"},{"key":"bibr37-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/abn0000876"},{"key":"bibr38-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1111\/j.1745-6916.2007.00029.x"},{"key":"bibr39-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1002\/cpp.1765"},{"key":"bibr40-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.1987.tb10566.x"},{"key":"bibr41-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1111\/ecc.12597"},{"key":"bibr42-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.psc.2016.04.005"},{"key":"bibr43-02698811241265756","doi-asserted-by":"publisher","DOI":"10.3390\/brainsci8030047"},{"key":"bibr44-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1093\/cb\/cbac008"},{"key":"bibr45-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2023.0099"},{"key":"bibr46-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2850.1995.tb00022.x"},{"key":"bibr47-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3961-8"},{"key":"bibr48-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2005.01073.x"},{"key":"bibr49-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-023-06204-3"},{"key":"bibr50-02698811241265756","unstructured":"National Cancer Institute (2017) Common Terminology Criteria for Adverse Events (CTCAE) Version 5. US Department of Health and Human Services, National Institutes of Health, National Cancer Institute."},{"key":"bibr51-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1055\/a-1312-7297"},{"key":"bibr52-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2022.12.042"},{"key":"bibr53-02698811241265756","doi-asserted-by":"publisher","DOI":"10.3389\/fnhum.2016.00269"},{"key":"bibr54-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.20230661"},{"key":"bibr55-02698811241265756","unstructured":"Office of Human Research Protections (2007) Unanticipated problems involving risks and adverse events guidance. United States Department of Health and Human Services. Available at: https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html#Q2 (accessed May 2024)."},{"key":"bibr56-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1021\/acsptsci.0c00192"},{"key":"bibr57-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2023.1554"},{"key":"bibr58-02698811241265756","author":"Palitsky R","journal-title":"Psychotherapy"},{"key":"bibr59-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.03.002"},{"key":"bibr60-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/1089-2680.1.2.115"},{"key":"bibr61-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.115.163618"},{"key":"bibr62-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/0001699320980050"},{"key":"bibr63-02698811241265756","volume-title":"A Theological Reckoning with \u201cBad Trips\u201d","author":"Petersen R","year":"2022"},{"key":"bibr64-02698811241265756","first-page":"221","volume-title":"Behavioral Neurobiology of Psychedelic Drugs. Current Topics in Behavioral Neurosciences","author":"Preller KH","year":"2018"},{"key":"bibr65-02698811241265756","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2022.831092"},{"key":"bibr66-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1007\/s10960-004-5794-8"},{"key":"bibr67-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-62703-131-8_36"},{"key":"bibr68-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2024.115880"},{"key":"bibr69-02698811241265756","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2017.00974"},{"key":"bibr70-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1192\/apt.10.4.312"},{"key":"bibr71-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/13634615211062962"},{"key":"bibr72-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/02698811211069100"},{"key":"bibr73-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2021.2022816"},{"key":"bibr74-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2023.01.073"},{"key":"bibr75-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2022.2039815"},{"key":"bibr76-02698811241265756","volume-title":"When Things Get Worse: The Problem of Negative Effects in Psychotherapy","author":"Strupp HH","year":"1977"},{"key":"bibr77-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/cps0000002"},{"key":"bibr78-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1177\/20451253231198466"},{"key":"bibr79-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1037\/a0017908"},{"key":"bibr80-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.abrep.2022.100454"},{"key":"bibr81-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcbs.2019.12.004"},{"key":"bibr82-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1556\/2054.2020.00137"},{"key":"bibr83-02698811241265756","doi-asserted-by":"publisher","DOI":"10.1021\/acsptsci.0c00194"}],"container-title":["Journal of Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02698811241265756","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/02698811241265756","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02698811241265756","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:11:46Z","timestamp":1777507906000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/02698811241265756"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,31]]},"references-count":83,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1177\/02698811241265756"],"URL":"https:\/\/doi.org\/10.1177\/02698811241265756","relation":{},"ISSN":["0269-8811","1461-7285"],"issn-type":[{"value":"0269-8811","type":"print"},{"value":"1461-7285","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,31]]}}}