Psychobiologic effects of 3,4-methylenedioxymethamphetamine in humans: methodological considerations and preliminary observations

Behav Brain Res. 1996;73(1-2):103-7. doi: 10.1016/0166-4328(96)00078-2.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Blood Pressure / drug effects
  • Body Temperature / drug effects
  • Central Nervous System / drug effects*
  • Cerebrovascular Circulation
  • Double-Blind Method
  • Female
  • Hallucinogens / pharmacology*
  • Heart Rate / drug effects
  • Hormones / blood
  • Humans
  • Male
  • N-Methyl-3,4-methylenedioxyamphetamine / pharmacology*
  • Prospective Studies
  • Serotonin / physiology*
  • Tomography, Emission-Computed, Single-Photon


  • Hallucinogens
  • Hormones
  • Serotonin
  • N-Methyl-3,4-methylenedioxyamphetamine