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 investigate the potential of genotoxic effects of MDMA treatment in humans: (1) an bacterial reverse mutation (Ames) assay, (2) an chromosome aberration test in Chinese hamster ovary cells, and (3) an micronucleus study in male Sprague Dawley rats.

High-resolution isotope-dilution mass spectrometry using metabolism of isotope-labeled compounds: application to drug metabolites.

Rationale: Herein we describe a generic quantitative method using high-resolution, isotope-dilution (HRID) metabolism of isotope-labeled compounds and apply it to the analysis of drug metabolites (DMs) in human plasma. Metabolites (drug) in Safety Testing (MIST) application was one goal.

Methods: Testosterone (T) and diclofenac (D) were chosen for mass defect characteristics.