{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T11:57:48Z","timestamp":1781611068007,"version":"3.54.5"},"reference-count":15,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T00:00:00Z","timestamp":1630368000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T00:00:00Z","timestamp":1630368000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Course of Employment for MAPS and MAPS PBC"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:p>\n                    3,4 Methylenedioxymethamphetamine (MDMA)-assisted therapy has been recently found to be highly effective for treatment of posttraumatic stress disorder (PTSD). Previous studies have been inconclusive in elucidating potential MDMA genotoxicity. We performed three regulatory compliant studies to investigate the potential of genotoxic effects of MDMA treatment in humans: (1) an\n                    <jats:italic toggle=\"yes\">in vitro<\/jats:italic>\n                    bacterial reverse mutation (Ames) assay, (2) an\n                    <jats:italic toggle=\"yes\">in vitro<\/jats:italic>\n                    chromosome aberration test in Chinese hamster ovary cells, and (3) an\n                    <jats:italic toggle=\"yes\">in vivo<\/jats:italic>\n                    micronucleus study in male Sprague Dawley rats. MDMA was found to not have genotoxic effects in any of the assays at or above clinically relevant concentrations.\n                  <\/jats:p>","DOI":"10.1177\/02698811211033603","type":"journal-article","created":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T02:14:53Z","timestamp":1630462493000},"page":"1431-1434","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Three regulatory compliant test systems show no signs of MDMA-related genotoxicity"],"prefix":"10.1177","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1827-2429","authenticated-orcid":false,"given":"Isaac Victor","family":"Cohen","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Therapeutics (CPT) Postdoctoral Training Program, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6551-6986","authenticated-orcid":false,"given":"Laken","family":"Barber","sequence":"additional","affiliation":[{"name":"Division of Biochemistry, Hawai\u2019i Pacific University, Honolulu, Hawaii"},{"name":"Safety Department, MAPS Public Benefit Corporation, San Jose, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tyson Paul","family":"Dubnicka","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Mattawan, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara Beth","family":"Hurtado","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Skokie, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah Ann","family":"Tincher","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Skokie, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Leon Frank","family":"Stankowski","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Skokie, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Berra","family":"Yazar-Klosinski","sequence":"additional","affiliation":[{"name":"Executive Department, Multidisciplinary Association for Psychedelic Studies, San Jose, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,8,31]]},"reference":[{"key":"e_1_3_2_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.toxlet.2009.08.002"},{"key":"e_1_3_2_3_1","unstructured":"Burge B (2020) PRESS RELEASE: Interim analysis shows at least 90% chance of statistically significant difference in PTSD symptoms after MDMA-assisted psychotherapy. MAPS in the Media. Available at: https:\/\/maps.org\/news\/media\/8154-press-release-interim-analysis-shows-at-least-90-chance-of-statistically-significant-difference-in-ptsd-symptoms-after-mdma-assisted-psychotherapy (accessed 11 November 2020)."},{"key":"e_1_3_2_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-800764-8.00008-2"},{"key":"e_1_3_2_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/FBP.0b013e3282d518aa"},{"key":"e_1_3_2_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-800764-8.00004-5"},{"key":"e_1_3_2_7_1","first-page":"44","article-title":"Assessing mutagenicity of the drug MDMA (ecstasy) available in Iran using Ames bioassay","volume":"5","author":"Hariri M","year":"2010","unstructured":"Hariri M, , Jalali A, , Farajzadeh A, et al. (2010) Assessing mutagenicity of the drug MDMA (ecstasy) available in Iran using Ames bioassay. Jundishapur Journal of Natural Pharmaceutical Products 5: 44\u201349.","journal-title":"Jundishapur Journal of Natural Pharmaceutical Products"},{"key":"e_1_3_2_8_1","unstructured":"ICH Expert Working Group (2011) ICH harmonised tripartite guideline: Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use S2(R1). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Available at: https:\/\/database.ich.org\/sites\/default\/files\/S2_R1_Guideline.pdf (accessed 11 November 2020)."},{"key":"e_1_3_2_9_1","first-page":"917","article-title":"The pharmacology and toxicology of \u2018ecstasy\u2019 (MDMA) and related drugs","volume":"165","author":"Kalant H","year":"2001","unstructured":"Kalant H (2001) The pharmacology and toxicology of \u2018ecstasy\u2019 (MDMA) and related drugs. Canadian Medical Association Journal 165: 917\u2013928.","journal-title":"Canadian Medical Association Journal"},{"key":"e_1_3_2_10_1","unstructured":"MDMA Investigator\u2019s Brochure 12th Edition (2020) MAPS PBC. Available at: https:\/\/mapscontent.s3-us-west-1.amazonaws.com\/research-archive\/MDMA+IB+12th+Edition+Final+17AUG2020.pdf (accessed 11 November 2020)."},{"key":"e_1_3_2_11_1","doi-asserted-by":"publisher","DOI":"10.1787\/9789264264649-en"},{"key":"e_1_3_2_12_1","doi-asserted-by":"publisher","DOI":"10.1787\/9789264264762-en"},{"key":"e_1_3_2_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11356-014-3094-2"},{"key":"e_1_3_2_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-800764-8.00007-0"},{"key":"e_1_3_2_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881117691569"},{"key":"e_1_3_2_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02898027"}],"container-title":["Journal of Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02698811211033603","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/02698811211033603","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02698811211033603","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T11:50:41Z","timestamp":1781610641000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/02698811211033603"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,31]]},"references-count":15,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2021,11]]}},"alternative-id":["10.1177\/02698811211033603"],"URL":"https:\/\/doi.org\/10.1177\/02698811211033603","relation":{},"ISSN":["0269-8811","1461-7285"],"issn-type":[{"value":"0269-8811","type":"print"},{"value":"1461-7285","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,31]]}}}