Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

The purpose of this study is to determinate the effect of a pre-treatment with the combined serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, “Ecstasy”). The investigators hypothesize that duloxetine will attenuate the subjective and cardiovascular response to MDMA.

Topic Healthy Subjects
Compound Placebo MDMA
Country Switzerland
Visit trial
Status Completed
Results Published Yes
Start date 11 January 2009
End date 05 January 2010
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 16
Sex All
Age 18- 45
Therapy No

Trial Details

3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), norepinephrine (NE), and dopamine through an interaction with the corresponding presynaptic monoamine uptake transporter. 5-HT transport inhibitors block MDMA-induced 5-HT release in vitro or in animals and also attenuate the subjective and cardiovascular response to MDMA in humans. NE transport inhibitors similarly prevent the MDMA-induced release of NE in cell assays and attenuate behavioral effects of MDMA in animals. Effects of the NE transporter inhibitor reboxetine on the response to MDMA in humans are currently investigated. Here we suggest evaluating effects of pretreatment with the combined 5-HT and NE transport blocker duloxetine on the pharmacodynamics and pharmacokinetics of MDMA. The study will use a randomized double-blind cross-over design with four experimental sessions. Duloxetine (120 mg) or placebo will be administered 16 h and 4 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective and cardiovascular responses and plasma samples for pharmacokinetics will be repeatedly assessed throughout the experiments.

NCT Number NCT00990067

Sponsors & Collaborators

University of Basel
The University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.

Papers

Sex differences in the effects of MDMA (ecstasy) on plasma copeptin in healthy subjects
This study used a randomized placebo-controlled crossover design to explore the sex differences in increased plasma arginine vasopressin (AVP) secretion following MDMA administration (125mg) in healthy subjects (8 male, 8 female). MDMA significantly elevated plasma copeptin levels at 60 min and at 120 min compared with placebo in women but not in men and MDMA tended to increase urine sodium levels and urine osmolality compared with placebo.

Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex
This study analysed data from five separate clinical trials (n=80) that explored the effects of MDMA on pupillary light reflex and the effects following pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin, respectively. MDMA produced mydriasis, prolonged the latency, reduced the response to light and shortened the recovery time and this impairment returned to normal 6 hours post-treatment. Only reboxetine and duloxetine interacted with the effects of MDMA on pupillary function.

Data attribution

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