PMID- 28443695
OWN - NLM
STAT- MEDLINE
DCOM- 20180216
LR  - 20180918
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Linking)
VI  - 31
IP  - 5
DP  - 2017 May
TI  - Safety pharmacology of acute MDMA administration in healthy subjects.
PG  - 576-588
LID - 10.1177/0269881117691569 [doi]
AB  - 3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in 
      MDMA-assisted psychotherapy. The present study characterized the safety 
      pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data 
      from nine double-blind, placebo-controlled, crossover studies performed in the 
      same laboratory in a total of 166 healthy subjects. The duration of the 
      subjective effects was 4.2 +/- 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA 
      produced greater 'good drug effect' ratings than 75 mg. MDMA produced moderate 
      and transient 'bad drug effect' ratings, which were greater in women than in men. 
      MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, 
      and body temperature >38 degrees C in 33%, 29% and 19% of the subjects, respectively. 
      These proportions of subjects with hypertension (>160 mmHg), tachycardia, and 
      body temperature >38 degrees C were all significantly greater after 125 mg MDMA compared 
      with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by 
      the List of Complaints were dose-dependent and more frequent in females. MDMA did 
      not affect liver or kidney function at EOS 29 +/- 22 days after use. No serious 
      adverse events occurred. In conclusion, MDMA produced predominantly acute 
      positive subjective drug effects. Bad subjective drug effects and other adverse 
      effects were significantly more common in women. MDMA administration was overall 
      safe in physically and psychiatrically healthy subjects and in a medical setting. 
      However, the risks of MDMA are likely higher in patients with cardiovascular 
      disease and remain to be investigated in patients with psychiatric disorders.
FAU - Vizeli, Patrick
AU  - Vizeli P
AD  - Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and 
      Department of Clinical Research, University Hospital Basel and University of 
      Basel, Basel, Switzerland.
FAU - Liechti, Matthias E
AU  - Liechti ME
AD  - Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and 
      Department of Clinical Research, University Hospital Basel and University of 
      Basel, Basel, Switzerland.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20170221
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Hallucinogens)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Blood Pressure/drug effects
MH  - Body Temperature/drug effects
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Hallucinogens/*administration & dosage/*adverse effects
MH  - Healthy Volunteers
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Male
MH  - N-Methyl-3,4-methylenedioxyamphetamine/*administration & dosage/*adverse effects
MH  - Psychomotor Performance/drug effects
OTO - NOTNLM
OT  - 3,4-methylenedioxymethamphetamine
OT  - Phase I
OT  - adverse effect
OT  - human
OT  - safety
EDAT- 2017/04/27 06:00
MHDA- 2018/02/17 06:00
CRDT- 2017/04/27 06:00
PHST- 2017/04/27 06:00 [pubmed]
PHST- 2018/02/17 06:00 [medline]
PHST- 2017/04/27 06:00 [entrez]
AID - 10.1177/0269881117691569 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2017 May;31(5):576-588. doi: 10.1177/0269881117691569. Epub 
      2017 Feb 21.