PMID- 34465250
OWN - NLM
STAT- MEDLINE
DCOM- 20220221
LR  - 20220221
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Print)
IS  - 0269-8811 (Linking)
VI  - 35
IP  - 11
DP  - 2021 Nov
TI  - Three regulatory compliant test systems show no signs of MDMA-related 
      genotoxicity.
PG  - 1431-1434
LID - 10.1177/02698811211033603 [doi]
AB  - 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.
FAU - Cohen, Isaac Victor
AU  - Cohen IV
AUID- ORCID: 0000-0003-1827-2429
AD  - Clinical Pharmacology and Therapeutics (CPT) Postdoctoral Training Program, 
      University of California San Francisco, San Francisco, CA, USA.
FAU - Barber, Laken
AU  - Barber L
AUID- ORCID: 0000-0002-6551-6986
AD  - Division of Biochemistry, Hawai'i Pacific University, Honolulu, Hawaii.
AD  - Safety Department, MAPS Public Benefit Corporation, San Jose, CA, USA.
FAU - Dubnicka, Tyson Paul
AU  - Dubnicka TP
AD  - Charles River Laboratories, Mattawan, MI, USA.
FAU - Hurtado, Sara Beth
AU  - Hurtado SB
AD  - Charles River Laboratories, Skokie, IL, USA.
FAU - Tincher, Sarah Ann
AU  - Tincher SA
AD  - Charles River Laboratories, Skokie, IL, USA.
FAU - Stankowski, Leon Frank Jr
AU  - Stankowski LF Jr
AD  - Charles River Laboratories, Skokie, IL, USA.
FAU - Yazar-Klosinski, Berra
AU  - Yazar-Klosinski B
AD  - Executive Department, Multidisciplinary Association for Psychedelic Studies, San 
      Jose, CA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210831
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Neurotransmitter Agents)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Animals
MH  - CHO Cells/*drug effects
MH  - Chromosome Aberrations/*drug effects
MH  - Cricetulus
MH  - Escherichia coli/*drug effects
MH  - Female
MH  - Male
MH  - Mutagenicity Tests
MH  - N-Methyl-3,4-methylenedioxyamphetamine/administration & dosage/*toxicity
MH  - Neurotransmitter Agents/administration & dosage/*toxicity
MH  - Rats
MH  - Rats, Sprague-Dawley
MH  - Salmonella typhimurium/*drug effects
MH  - Stress Disorders, Post-Traumatic/*drug therapy
PMC - PMC8600592
OTO - NOTNLM
OT  - 3,4-Methylenedioxymethamphetamine
OT  - Genotoxicity
OT  - MDMA
OT  - PTSD
OT  - Toxicology
COIS- Declaration of conflicting interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: BYK is a paid employee of the 501(c)3 non-profit 
      MAPS, the sponsor of this study, with a joint appointment at MAPS PBC, a wholly 
      owned subsidiary of MAPS. LB is a paid intern at MAPS PBC. TPD, SBH, SAT, and LFS 
      are paid employees of Charles River Labs where the experiments funded by MAPS 
      were performed.
EDAT- 2021/09/02 06:00
MHDA- 2022/02/22 06:00
PMCR- 2021/11/18
CRDT- 2021/09/01 05:41
PHST- 2021/09/02 06:00 [pubmed]
PHST- 2022/02/22 06:00 [medline]
PHST- 2021/09/01 05:41 [entrez]
PHST- 2021/11/18 00:00 [pmc-release]
AID - 10.1177_02698811211033603 [pii]
AID - 10.1177/02698811211033603 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2021 Nov;35(11):1431-1434. doi: 10.1177/02698811211033603. 
      Epub 2021 Aug 31.