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Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01465685
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : January 21, 2016
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
This study compares the interactive emotional/subjective effects of single doses of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") and methylphenidate, a dopamine (DA) and norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to determine the role of transporter mediated DA and NE release in the subjective response to MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the subjective response to MDMA.

Condition or disease Intervention/treatment Phase
Healthy Drug: 3,4-Methylenedioxymethamphetamine Drug: Methylphenidate Drug: Placebo Phase 1

Detailed Description:
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE). 5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is involved in the cardiovascular and psychostimulant effects of MDMA. DA is also likely to be involved in the rewarding and reinforcing effects of drugs of abuse. However, the functional role of DA in the subjective effects of MDMA in humans is largely unclear. To determine the role of the DA transporter (DAT) in the response to MDMA in humans the investigators test the effects of the DA and NE transporter blocker methylphenidate on the subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. methylphenidate or placebo will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that methylphenidate will significantly reduce the subjective effects of MDMA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Emotional Effects of Methylphenidate and MDMA in Healthy Subjects
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Experimental: MDMA, methylphenidate, 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
125 mg per os, single dose
Other Names:
  • MDMA
  • ecstasy

Drug: Methylphenidate
1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose
Other Names:
  • Ritalin
  • Concerta

Drug: Placebo
capsules identical to MDMA or methylphenidate

Primary Outcome Measures :
  1. Subjective effect during 24 hours [ Time Frame: 24 hours ]
    subjective effects are repetitively assessed by standardized questionnaires.

Secondary Outcome Measures :
  1. Blood pressure (mmHg)during 10 hours [ Time Frame: 10 hours ]
  2. Neuroendocrine plasma levels during 10 hours [ Time Frame: 10 hours ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone

  3. MDMA plasma levels during 24 hours [ Time Frame: 24 hours ]
  4. Heart rate (beats/min)) during 10 hours [ Time Frame: 10 ]
  5. Emotional and cognitive empathy [ Time Frame: 5 hours ]

    emotional empathy is going to be assessed by the Multifaceted Empathy Test (MET).

    cognitive empathy is going to be assessed by the Facial Emotion Recognition Task and the MET.

  6. Prosocial behavior [ Time Frame: 5 hours ]
    Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.

  7. Genetic polymorphisms [ Time Frame: assessed after study completion ]
    Effects of genetic polymorphisms on the response to MDMA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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-containing (tetrahydrocannabinol) 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465685

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University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01465685    
Other Study ID Numbers: EK 228/11
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Basel, Switzerland:
Mechanism of action of MDMA
Interaction study
Effect of MDMA and methylphenidate on emotions
Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Psychotropic Drugs
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents