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MDMA Investigator's Brochure

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MDMA Investigator's Brochure Investigator’s Brochure SPONSOR Multidisciplinary Association for Psychedelic Studies (MAPS) PRODUCT 3,4-methylenedioxymethamphetamine (MDMA) IND # 063384 DATA CUT-OFF DATE 01 October 2016 EFFECTIVE DATE 21 May 2017 EDITION 9th Edition REPLACES 8th Edition (dated 30 March 2016) MAPS MDMA Investigator’s Brochure U.S. 9th Edition: 21 May 2017 Table of Contents List of Tables ..................................................................................................................... 4 List of Figures .................................................................................................................... 7 List of Abbreviations ........................................................................................................ 7 1.0 Summary ...................................................................................................................... 9 2.0 Introduction ............................................................................................................... 11 3.0 Physical, Chemical, and Pharmaceutical Properties and Formulation ............... 13 4.0 Nonclinical Studies .................................................................................................... 14 4.1 Nonclinical Pharmacology ................................................................................................ 15 4.2 Pharmacology in Animals ................................................................................................. 15 4.2.1 Pharmacokinetics in Animals ....................................................................................... 15 4.2.2 Pharmacodynamics in Animals .................................................................................... 17 4.2.2.1 Stable Effects on Gene Expression in Animals .................................................... 18 4.2.2.2 Immunological Effects in Animals ....................................................................... 19 4.2.2.3 Thermoregulatory Effects in Animals................................................................... 20 4.2.2.4 Cardiovascular Effects in Animals ....................................................................... 20 4.2.2.5 Osmoregulatory Effects in Animals ...................................................................... 20 4.2.2.6 Neurobiological Effects in Animals ...................................................................... 21 4.2.2.7 Neuropsychological Effects in Animals ............................................................... 22 4.3 Physiological Effects in Epidemiological Settings ........................................................... 23 4.3.1 Immunological Effects ................................................................................................. 23 4.3.2 Thermoregulatory Effects ............................................................................................ 24 4.3.3 Cardiovascular Effects ................................................................................................. 24 4.3.4 Osmoregulatory Effects ................................................................................................ 24 4.3.5 Neurobiological Effects ................................................................................................ 24 4.3.6 Neuropsychological Effects ......................................................................................... 26 4.4 Toxicology in Animals and Epidemiological Settings ..................................................... 27 4.4.1 Single Dose Studies in Animals ................................................................................... 27 4.4.2 Repeated Dose Studies in Animals .............................................................................. 28 4.4.3 Genotoxicity ................................................................................................................. 28 4.4.4 Carcinogenicity ............................................................................................................ 28 4.4.5 Reproductive and Developmental Toxicity .................................................................. 29 4.4.6 Hyperthermia ................................................................................................................ 31 4.4.7 Cardiovascular Toxicity ............................................................................................... 32 4.4.8 Hyponatremia ............................................................................................................... 32 4.4.9 Hepatotoxicity .............................................................................................................. 33 4.4.10 Neurotoxicity .............................................................................................................. 33 4.5 Serious Reports of Incidents, Mortality, and Morbidity in Animals and Epidemiological Settings ......................................................................................................... 35 4.6 Abuse Potential in Nonclinical Studies ............................................................................ 41 5.0 Effects in Humans in Clinical Settings .................................................................... 42 5.1 History of Use in Clinical Settings .................................................................................... 42 5.2 Pharmacology in Humans ................................................................................................. 44 5.2.1 Pharmacokinetics ......................................................................................................... 44 5.2.2 Pharmacodynamics....................................................................................................... 46 5.3 Safety of MDMA in Humans ............................................................................................ 49 5.3.1 Reproductive and Developmental ................................................................................ 50 5.3.2 Immunological Effects ................................................................................................. 50 5.3.3 Thermoregulatory Effects ............................................................................................ 51 5.3.4 Cardiovascular Effects ................................................................................................. 54 Page 2 of 187 MAPS MDMA Investigator’s Brochure U.S. 9th Edition: 21 May 2017 5.3.5 Osmoregulatory Effects ................................................................................................ 64 5.3.6 Hepatic Effects ............................................................................................................. 64 5.3.7 Neurobiological Effects ................................................................................................ 65 5.3.8 Neuropsychological Effects ......................................................................................... 66 5.3.8.1 Cognitive Function................................................................................................ 67 5.3.8.2 Perceptual Effects ................................................................................................. 69 5.3.8.3 Social Effects ........................................................................................................ 70 5.3.8.4 Emotional Effects.................................................................................................. 71 5.3.8.5 Suicidal Ideation, Behavior, and Depression ........................................................ 72 5.3.9 Adverse Events ............................................................................................................. 82 5.3.9.1 Commonly Reported Adverse Events ................................................................... 82 5.3.9.2 Adverse Events ................................................................................................... 106 5.3.9.3 Serious Adverse Events ...................................................................................... 120 5.3.10 Abuse Potential ........................................................................................................ 122 5.4 5.4 Efficacy of MDMA Across Populations ................................................................... 131 5.4.1 PTSD .......................................................................................................................... 131 5.4.2 Social Anxiety in Autistic Adults ............................................................................... 132 5.4.3 Anxiety Associated with Life-Threatening Illness ..................................................... 133 6.0 Summary of Data and Guidance for the Investigator ......................................... 133 6.1 Pharmacology .................................................................................................................. 133 6.2 Toxicology ........................................................................................................................ 134 6.3 Physiological Effects ........................................................................................................ 136 6.3.1 Immunological Effects ............................................................................................... 137 6.3.2 Hepatic Effects ........................................................................................................... 138 6.4 Suicidal Ideation, Behavior, and Depression
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