NCT01616407

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

June 7, 2012

Last Update Submit

December 10, 2018

Conditions

Social Cognition

Keywords

Effects of psychostimulants on emotion recognition and empathy

Outcome Measures

Primary Outcomes (1)

  • Effects on social cognition (emotion recognition and empathy)

    7 hours

Secondary Outcomes (4)

  • Blood pressure (mmHg) and heart rate (beats per min)

    7 hours

  • Subjective effects

    7 hours

  • Neuroendocrine plasma levels

    7 hours

  • Drug plasma concentration

    7 hours

Other Outcomes (1)

  • Genetic polymorphisms

    assessed after study completion

Study Arms (1)

MDMA, methylphenidate, placebo

EXPERIMENTAL

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-MethylenedioxymethamphetamineDrug: MethylphenidateDrug: Placebo

Interventions

3,4-MethylenedioxymethamphetamineDRUG

75 mg per os, single dose

Also known as: - MDMA, - ecstasy
MDMA, methylphenidate, placebo
MethylphenidateDRUG

40 mg per os, single dose

Also known as: - Ritalin, - Concerta
MDMA, methylphenidate, placebo
PlaceboDRUG

capsules identical to MDMA or methylphenidate but containing no active drug

MDMA, methylphenidate, placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Schmid Y, Hysek CM, Simmler LD, Crockett MJ, Quednow BB, Liechti ME. Differential effects of MDMA and methylphenidate on social cognition. J Psychopharmacol. 2014 Sep;28(9):847-56. doi: 10.1177/0269881114542454. Epub 2014 Jul 22.

    PMID: 25052243DERIVED

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamineMethylphenidate

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Matthias E Liechti, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

CH(1)