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Effects of the α₂-adrenergic agonist clonidine on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine in healthy volunteers.

The Journal of pharmacology and experimental therapeutics
February 1, 2012
Cédric M Hysek et al. (8 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether clonidine, an α₂-adrenergic receptor agonist, could mitigate the cardiovascular and psychotropic effects of MDMA by inhibiting norepinephrine release.

Results Summary

Clonidine reduced MDMA-induced increases in plasma norepinephrine and blood pressure but did not affect psychotropic effects or pharmacokinetics, indicating vesicular norepinephrine release is not critical to MDMA's effects in humans.

Population

16 healthy subjects

Effective Dosage

125 mg p.o. MDMA, 150 μg p.o. clonidine

Duration

Not specified

Interactions

Clonidine (no significant interaction with MDMA)

Extracted Claims (8)
InterventionDirectionEndpointPopulationDosageImpactClaim #
clonidine (150 μg p.o.)
decrease
MDMA-induced increases in plasma norepinephrine concentrations
16 healthy subjects
-
reduced
#1
clonidine (150 μg p.o.)
decrease
MDMA-induced increases in blood pressure
16 healthy subjects
-
reduced
#2
clonidine
decrease
norepinephrine levels
16 healthy subjects
-
lowered
#3
clonidine
decrease
blood pressure
16 healthy subjects
-
lowered
#4
clonidine
no change
psychotropic effects of MDMA
16 healthy subjects
-
did not affect
#5
clonidine
no change
pharmacokinetics of MDMA
16 healthy subjects
-
did not affect
#6
MDMA (125 mg p.o.)
increase
plasma norepinephrine concentrations
16 healthy subjects
-
increases
#7
MDMA (125 mg p.o.)
increase
blood pressure
16 healthy subjects
-
increases
#8
Abstract

The mechanism of action of 3,4-methylenedioxymethamphetamine (MDMA; ecstasy) involves the carrier-mediated and potentially vesicular release of monoamines. We assessed the effects of the sympatholytic α₂-adrenergic receptor agonist clonidine (150 μg p.o.), which inhibits the neuronal vesicular release of norepinephrine, on the cardiovascular and psychotropic response to MDMA (125 mg p.o.) in 16 healthy subjects. The study used a randomized, double-blind, placebo-controlled crossover design with four experimental sessions. The administration of clonidine 1 h before MDMA reduced the MDMA-induced increases in plasma norepinephrine concentrations and blood pressure but only to the extent that clonidine lowered norepinephrine levels and blood pressure compared with placebo. Thus, no interaction was found between the cardiovascular effects of the two drugs. Clonidine did not affect the psychotropic effects or pharmacokinetics of MDMA. The lack of an interaction of the effects of clonidine and MDMA indicates that vesicular release of norepinephrine, which is inhibited by clonidine, does not critically contribute to the effects of MDMA in humans. Although clonidine may be used in the treatment of stimulant-induced hypertensive reactions, the present findings do not support a role for α₂-adrenergic receptor agonists in the prevention of psychostimulant dependence.

Medical Subject Headings (MeSH)
3,4-MethylenedioxyamphetamineAdrenergic alpha-2 Receptor AgonistsAdultAffectBlood PressureBody TemperatureBrainClonidineConsciousnessCross-Over StudiesDouble-Blind MethodDrug InteractionsEmotionsEpinephrineFemaleHeart RateHumansMaleMental ProcessesN-Methyl-3,4-methylenedioxyamphetamineNorepinephrineYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy50/10
Quality85/10
Citation Metrics
Total Citations55
Citations/Year4.2
Relative Citation Ratio2.30
NIH Percentile78.6%
Research Impact Scores
APT Score0.75
Weight Score1.59
Normalized Score0.57
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