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Despite enduring consensus of the influence of setting, recommendations for establishing and reporting key setting variables remain sparse across clinical trial protocols and published research methodologies. The purpose of this paper is to: (1) present what is known of the influence and implications of setting to psychedelic-assisted therapies, with a particular focus on 3,4-methylenedioxymethamphetamine (MDMA); and (2) propose a set of reporting guidelines for operationalizing and reporting key setting variables in clinical trials of psychedelic-assisted therapies, based on recommendations emerging from clinical trials of MDMA for PTSD. In fact, recommendations should be expanded to \u201cset\u201d - the subject's mood, expectations, and broader psychological condition - once this is more fully developed in the field. The proposed reporting guidelines offer a means of increasing the volume and variability of data necessary for future empirical examination of key setting attributes influencing treatment efficacy, while preserving practitioner and patient autonomy to co-construct adaptive therapy settings according to their respective needs and expertise.<\/jats:p>","DOI":"10.3389\/fpsyt.2022.965641","type":"journal-article","created":{"date-parts":[[2022,11,3]],"date-time":"2022-11-03T04:50:53Z","timestamp":1667451053000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":23,"title":["Therapeutic setting as an essential component of psychedelic research methodology: Reporting recommendations emerging from clinical trials of 3,4-methylenedioxymethamphetamine for post-traumatic stress disorder"],"prefix":"10.3389","volume":"13","author":[{"given":"Lauren","family":"Okano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bri","family":"Deyo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alida","family":"Brandenburg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wesley","family":"Hale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,11,3]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1080\/02791072.2019.1606472","article-title":"The past and future of psychedelic science: an introduction to this issue","volume":"51","author":"Doblin","year":"2019","journal-title":"J Psychoactive Drugs."},{"key":"B2","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1080\/02791072.2021.2022254","article-title":"The psychedelic renaissance in clinical research: a bibliometric analysis of three decades of human studies with psychedelics","author":"Hadar","year":"2022","journal-title":"J Psychoactive Drugs."},{"key":"B3","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1177\/0269881114555249","article-title":"LSD-assisted psychotherapy for anxiety associated with a life-threatening disease: a qualitative study of acute and sustained subjective effects","volume":"29","author":"Gasser","year":"2014","journal-title":"J Psychopharmacology."},{"key":"B4","doi-asserted-by":"publisher","first-page":"619","DOI":"10.1016\/S2215-0366(16)30065-7","article-title":"Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study","volume":"3","author":"Carhart-Harris","year":"2016","journal-title":"Lancet Psychiatry."},{"key":"B5","volume-title":"Ayahuasca for the Treatment of Depression Current Topics in Behavioral Neurosciences","author":"Palhano-Fontes","year":"2021"},{"key":"B6","unstructured":"BusbyM,.\n          Biden administration plans for legal psychedelic therapies within two years. 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