Effects of MDMA and Methylphenidate on Social Cognition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01616407
First received: June 7, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess and compare the effects of a single dose of 3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective perception for positive and impairs perception for negative emotional stimuli compared to placebo or MPH.


Condition Intervention Phase
Social Cognition
Drug: 3,4-Methylenedioxymethamphetamine
Drug: Methylphenidate
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Effects on social cognition (emotion recognition and empathy) [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure (mmHg) and heart rate (beats per min) [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
  • Subjective effects [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    subjective effects are repetitively assessed by standardized questionnaires

  • Neuroendocrine plasma levels [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone

  • Drug plasma concentration [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    The plasma concentration of MDMA and MPH is repetitively assessed.


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


Enrollment: 30
Study Start Date: August 2012
Study Completion Date: April 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 three treatment conditions in the same subject.
Drug: 3,4-Methylenedioxymethamphetamine
75 mg per os, single dose
Other Names:
  • - MDMA
  • - ecstasy
Drug: Methylphenidate
40 mg per os, single dose
Other Names:
  • - Ritalin
  • - Concerta
Drug: Placebo
capsules identical to MDMA or methylphenidate but containing no active drug

  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 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: NCT01616407

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
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: NCT01616407     History of Changes
Other Study ID Numbers: EK 382/11, 2012DR1018
Study First Received: June 7, 2012
Last Updated: April 25, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Effects of psychostimulants on emotion recognition and empathy

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

ClinicalTrials.gov processed this record on October 20, 2014