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CompletedNCT00990067Updated Jan 25, 2013

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

A Phase 1 interventional study of 3,4-Methylenedioxymethamphetamine and Duloxetine in Mood Disorder, Substance-Related Disorders and Amphetamine-Related Disorders, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-25.

Sponsored by University Hospital, Basel, Switzerland · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Mood Disorder
  • Substance-Related Disorders
  • Amphetamine-Related Disorders

Keywords

  • MDMA
  • serotonin
  • norepinephrine
  • Ecstasy
  • stimulant
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 16 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Sufficient understanding of the German language
  • Subjects understand the procedures and the risks associated with the study
  • Participants must be willing to adhere to the protocol and sign the consent form
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
  • Body mass index: 18-25 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
  • Current or previous psychotic or affective disorder
  • Psychotic or affective disorder in first-degree relatives
  • Prior illicit drug use (except THC (Tetrahydrocannabinol)-containing products) more than 5 times or any time within the previous 2 months.
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Other
    duloxetine, MDMA, placebo

    Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.

    Drug: 3,4-Methylenedioxymethamphetamine · Drug: Duloxetine · Drug: Placebo

Interventions

  • Drug3,4-Methylenedioxymethamphetamine

    125 mg, single dose

    Also known as: MDMA, Ecstasy

  • DrugDuloxetine

    120 mg two doses 12h and 2h before MDMA

    Also known as: Cymbalta (r)

  • DrugPlacebo

    capsules identical to MDMA or duloxetine

06

What researchers measure

Primary outcomes

  1. Effect of duloxetine on the subjective response to MDMA

    Time frame: 24h

Secondary outcomes

  1. Effect of duloxetine on cardiovascular effects of MDMA

    Time frame: 6h

  2. Effect of duloxetine on pharmacokinetics of MDMA

    Time frame: 6h

  3. Effect of MDMA on duloxetine pharmacokinetics

    Time frame: 6h

  4. Tolerability of MDMA and duloxetine

    Time frame: 7 days

  5. Effect of duloxetine on neuroendocrine responses to MDMA

    Time frame: 6h

Other outcomes

  1. Genetic polymorphisms

    Effects of genetic polymorphisms on the response to MDMA

    Time frame: assessed after study completion

07

Study locations

1 site
  • Clinical Pharmacology & Toxicology, University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Publications

  • Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018. PubMed 29912955 ↗
  • Hysek CM, Liechti ME. Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex. Psychopharmacology (Berl). 2012 Dec;224(3):363-76. doi: 10.1007/s00213-012-2761-6. Epub 2012 Jun 15. PubMed 22700038 ↗
  • Hysek CM, Simmler LD, Nicola VG, Vischer N, Donzelli M, Krahenbuhl S, Grouzmann E, Huwyler J, Hoener MC, Liechti ME. Duloxetine inhibits effects of MDMA ("ecstasy") in vitro and in humans in a randomized placebo-controlled laboratory study. PLoS One. 2012;7(5):e36476. doi: 10.1371/journal.pone.0036476. Epub 2012 May 4. PubMed 22574166 ↗
  • Simmler LD, Hysek CM, Liechti ME. Sex differences in the effects of MDMA (ecstasy) on plasma copeptin in healthy subjects. J Clin Endocrinol Metab. 2011 Sep;96(9):2844-50. doi: 10.1210/jc.2011-1143. Epub 2011 Jun 29. PubMed 21715530 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00990067
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Oct 6, 2009
Start date
Nov 2009
Primary completion
May 2010
Completion
May 2010
Last update
Jan 25, 2013

Study contacts

Matthias E Liechti, MD
principal investigator · Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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