title: Psychobiologic effects of 3,4-methylenedioxymethamphetamine in humans: methodological considerations and preliminary observations.
abstract: 3,4-Methylenedioxymethamphetamine (MDMA) is a phenethylamine with potent effects on serotonergic neurotransmission which has been the object of controversy over its potential as a therapeutic adjunct versus its possible risks for causing neurotoxic injury. This paper discusses the background, methodology and preliminary findings of the first FDA approved Phase I study prospectively evaluating the effects of MDMA administration in humans. Six subjects with prior experience with MDMA were administered two different dosages of MDMA and an inactive placebo utilizing a randomized, double-blind methodologic design. Dosages from 0.25 to 1.0 mg/kg, p.o., were administered. All subjects tolerated the procedures without any overt evidence of physical discomfort or psychological distress. MDMA produced a modest increase in heart rate and blood pressure. The threshold dose for the stimulation of ACTH and prolactin appeared to be between 0.5 and 0.75 mg/kg, with the two higher doses clearly stimulating both ACTH and prolactin. Methodology for assessing MDMA's effects on serotonergic neurotransmission is discussed.
authors.affiliation: Department of Psychiatry, Harbor-UCLA Medical Center, Torrance 90509, USA.
authors.forename: C S
authors.initials: CS
authors.lastname: Grob
authors.forename: R E
authors.initials: RE
authors.lastname: Poland
authors.forename: L
authors.initials: L
authors.lastname: Chang
authors.forename: T
authors.initials: T
authors.lastname: Ernst
mesh_terms: D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001831:Body Temperature / Q000187:drug effects; D002490:Central Nervous System / Q000187:drug effects*; D002560:Cerebrovascular Circulation; D004311:Double-Blind Method; D005260:Female; D006213:Hallucinogens / Q000494:pharmacology*; D006339:Heart Rate / Q000187:drug effects; D006728:Hormones / Q000097:blood; D006801:Humans; D008297:Male; D018817:N-Methyl-3,4-methylenedioxyamphetamine / Q000494:pharmacology*; D011446:Prospective Studies; D012701:Serotonin / Q000502:physiology*; D015899:Tomography, Emission-Computed, Single-Photon
chemical_list: D006213:Hallucinogens; D006728:Hormones; D012701:Serotonin; D018817:N-Methyl-3,4-methylenedioxyamphetamine