Three regulatory compliant test systems show no signs of MDMA-related genotoxicity

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 inves...

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Autores principales: Cohen, Isaac Victor, Barber, Laken, Dubnicka, Tyson Paul, Hurtado, Sara Beth, Tincher, Sarah Ann, Stankowski, Leon Frank, Yazar-Klosinski, Berra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Null Results in Brief
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8600592/
https://www.ncbi.nlm.nih.gov/pubmed/34465250
http://dx.doi.org/10.1177/02698811211033603
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author Cohen, Isaac Victor
Barber, Laken
Dubnicka, Tyson Paul
Hurtado, Sara Beth
Tincher, Sarah Ann
Stankowski, Leon Frank
Yazar-Klosinski, Berra
author_facet Cohen, Isaac Victor
Barber, Laken
Dubnicka, Tyson Paul
Hurtado, Sara Beth
Tincher, Sarah Ann
Stankowski, Leon Frank
Yazar-Klosinski, Berra
author_sort Cohen, Isaac Victor
collection PubMed
description 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 in vitro bacterial reverse mutation (Ames) assay, (2) an in vitro chromosome aberration test in Chinese hamster ovary cells, and (3) an in vivo 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.
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spelling pubmed-86005922021-11-19 Three regulatory compliant test systems show no signs of MDMA-related genotoxicity Cohen, Isaac Victor Barber, Laken Dubnicka, Tyson Paul Hurtado, Sara Beth Tincher, Sarah Ann Stankowski, Leon Frank Yazar-Klosinski, Berra J Psychopharmacol Null Results in Brief 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 in vitro bacterial reverse mutation (Ames) assay, (2) an in vitro chromosome aberration test in Chinese hamster ovary cells, and (3) an in vivo 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. SAGE Publications 2021-08-31 2021-11 /pmc/articles/PMC8600592/ /pubmed/34465250 http://dx.doi.org/10.1177/02698811211033603 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Null Results in Brief
Cohen, Isaac Victor
Barber, Laken
Dubnicka, Tyson Paul
Hurtado, Sara Beth
Tincher, Sarah Ann
Stankowski, Leon Frank
Yazar-Klosinski, Berra
Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title_full Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title_fullStr Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title_full_unstemmed Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title_short Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
title_sort three regulatory compliant test systems show no signs of mdma-related genotoxicity
topic Null Results in Brief
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8600592/
https://www.ncbi.nlm.nih.gov/pubmed/34465250
http://dx.doi.org/10.1177/02698811211033603
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