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 (opens in new tab)
Study at a glance
AI-extracted from the abstract| 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 Hallucinogen In vivo Toxicology Genetics Cell culture |
| Citations | 1 |
| Key points | 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.