Trial record 9 of 35 for:    MDMA

Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01465685
First received: October 28, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Healthy
Drug: 3,4-Methylenedioxymethamphetamine
Drug: Methylphenidate
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Subjective effect during 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    subjective effects are repetitively assessed by standardized questionnaires.


Secondary Outcome Measures:
  • Blood pressure (mmHg)during 10 hours [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Neuroendocrine plasma levels during 10 hours [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone

  • MDMA plasma levels during 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Heart rate (beats/min)) during 10 hours [ Time Frame: 10 ] [ Designated as safety issue: No ]
  • Emotional and cognitive empathy [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

    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.


  • Prosocial behavior [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.

  • Genetic polymorphisms [ Time Frame: assessed after study completion ] [ Designated as safety issue: No ]
    Effects of genetic polymorphisms on the response to MDMA


Enrollment: 16
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465685

Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
  More Information

Additional Information:
No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01465685     History of Changes
Other Study ID Numbers: EK 228/11
Study First Received: October 28, 2011
Last Updated: August 27, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
MDMA
pharmacokinetics
pharmacodynamics
emotions
Mechanism of action of MDMA
Interaction study
Effect of MDMA and methylphenidate on emotions

Additional relevant MeSH terms:
Methylphenidate
N-Methyl-3,4-methylenedioxyamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Hallucinogens
Psychotropic Drugs
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on September 22, 2014