PMID- 8788485
OWN - NLM
STAT- MEDLINE
DCOM- 19961204
LR  - 20190826
IS  - 0166-4328 (Print)
IS  - 0166-4328 (Linking)
VI  - 73
IP  - 1-2
DP  - 1996
TI  - Psychobiologic effects of 3,4-methylenedioxymethamphetamine in humans: 
      methodological considerations and preliminary observations.
PG  - 103-7
AB  - 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.
FAU - Grob, C S
AU  - Grob CS
AD  - Department of Psychiatry, Harbor-UCLA Medical Center, Torrance 90509, USA.
FAU - Poland, R E
AU  - Poland RE
FAU - Chang, L
AU  - Chang L
FAU - Ernst, T
AU  - Ernst T
LA  - eng
GR  - DA 06863/DA/NIDA NIH HHS/United States
GR  - MH 00534/MH/NIMH NIH HHS/United States
GR  - RR 00425/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - Netherlands
TA  - Behav Brain Res
JT  - Behavioural brain research
JID - 8004872
RN  - 0 (Hallucinogens)
RN  - 0 (Hormones)
RN  - 333DO1RDJY (Serotonin)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Adult
MH  - Blood Pressure/drug effects
MH  - Body Temperature/drug effects
MH  - Central Nervous System/*drug effects
MH  - Cerebrovascular Circulation
MH  - Double-Blind Method
MH  - Female
MH  - Hallucinogens/*pharmacology
MH  - Heart Rate/drug effects
MH  - Hormones/blood
MH  - Humans
MH  - Male
MH  - N-Methyl-3,4-methylenedioxyamphetamine/*pharmacology
MH  - Prospective Studies
MH  - Serotonin/*physiology
MH  - Tomography, Emission-Computed, Single-Photon
EDAT- 1996/01/01 00:00
MHDA- 1996/01/01 00:01
CRDT- 1996/01/01 00:00
PHST- 1996/01/01 00:00 [pubmed]
PHST- 1996/01/01 00:01 [medline]
PHST- 1996/01/01 00:00 [entrez]
AID - 0166-4328(96)00078-2 [pii]
AID - 10.1016/0166-4328(96)00078-2 [doi]
PST - ppublish
SO  - Behav Brain Res. 1996;73(1-2):103-7. doi: 10.1016/0166-4328(96)00078-2.