Three regulatory compliant test systems show no signs of MDMA-related genotoxicity
Isaac Cohen, Laken Barber, Tyson Paul Dubnicka, Sara Hurtado, Sarah Ann Tincher, Leon F. Stankowski, Berra Yazar‐klosinski
Journal of Psychopharmacology August 31, 2021 DOI: 10.1177/02698811211033603 via OpenAlex
Summary
AI-generated from the abstract3,4-Methylenedioxymethamphetamine (MDMA)-assisted therapy is highly effective for posttraumatic stress disorder (PTSD). Previous research on MDMA's potential to damage DNA (genotoxicity) has been inconclusive. Three regulatory-compliant studies—a bacterial reverse mutation (Ames) assay, a chromosome aberration test in Chinese hamster ovary cells, and an in vivo micronucleus study in male Sprague Dawley rats—found that MDMA did not cause genotoxic effects at or above clinically relevant concentrations.
Study at a glance
| Characteristics | In vitro and in vivo toxicology study Peer reviewed |
|---|---|
| Population | Chinese hamster ovary cells, male Sprague Dawley rats, and bacterial strains |
| Interventions | 3 4-Methylenedioxymethamphetamine (MDMA) |
| Topics | MDMA |
| Keywords | Genotoxicity Micronucleus test Pharmacology Chromosome aberration |
| Citations | 1 |
| Key finding | MDMA was not genotoxic in any of the three assays at or above clinically relevant concentrations. |
Abstract
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.