Trial record 2 of 32 for:    "N-Methyl-3,4-methylenedioxyamphetamine"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00990067
First received: October 5, 2009
Last updated: January 24, 2013
Last verified: January 2013

October 5, 2009
January 24, 2013
November 2009
May 2010   (final data collection date for primary outcome measure)
Effect of duloxetine on the subjective response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990067 on ClinicalTrials.gov Archive Site
  • Effect of duloxetine on cardiovascular effects of MDMA [ Time Frame: 6h ] [ Designated as safety issue: No ]
  • Effect of duloxetine on pharmacokinetics of MDMA [ Time Frame: 6h ] [ Designated as safety issue: No ]
  • Effect of MDMA on duloxetine pharmacokinetics [ Time Frame: 6h ] [ Designated as safety issue: No ]
  • Tolerability of MDMA and duloxetine [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Effect of duloxetine on neuroendocrine responses to MDMA [ Time Frame: 6h ] [ Designated as safety issue: No ]
Same as current
Genetic polymorphisms [ Time Frame: assessed after study completion ] [ Designated as safety issue: No ]
Effects of genetic polymorphisms on the response to MDMA
Not Provided
 
Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)
Pharmacological Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy): Pharmacodynamics (PD) and Pharmacokinetics (PK)

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Mood Disorder
  • Substance-Related Disorders
  • Amphetamine-Related Disorders
  • Drug: 3,4-Methylenedioxymethamphetamine
    125 mg, single dose
    Other Names:
    • MDMA
    • Ecstasy
  • Drug: Duloxetine
    120 mg two doses 12h and 2h before MDMA
    Other Name: Cymbalta (r)
  • Drug: Placebo
    capsules identical to MDMA or duloxetine
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.
Interventions:
  • Drug: 3,4-Methylenedioxymethamphetamine
  • Drug: Duloxetine
  • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2010
May 2010   (final data collection date for primary outcome measure)

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:

  • 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.)
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00990067
EKBB 253/09
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Matthias E Liechti, MD Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP