Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study

NCT01951508 | Completed Early Phase 1 DMC

• 1 other identifier: EK 36/13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate effects of methylphenidate, modafinil, and 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") on emotion-processing and cognitive performance using functional magnetic resonance imaging (fMRI) techniques. The primary hypothesis is that these psychostimulants differentially affect processing of emotional stimuli and potentially leading to alterations in social cognition and behavior.

Conditions

Healthy; Substance-related Disorder; Mood Disorder

Keywords

Methylphenidate; Modafinil; MDMA; fMRI; emotion-processing; social cognition

Outcome Measures

Primary Outcomes (2)

• Effect on amygdala and striatum BOLD signal responses to emotional stimuli

  Functional magnetic resonance (MR) images measuring BOLD (blood oxygen level dependency)activity while subjects will be presented with a series of images of human faces, each showing a fearful or a neutral expression, in an event-related design.

  1.5h

• Effects on cognitive performance and associated BOLD signal changes in frontal areas

  Functional magnetic resonance (MR) images measuring BOLD (blood oxygen level dependency)activity while subjects perform a response inhibition/attention task.

  1.5h

Secondary Outcomes (6)

• Subjective effects

  7h

• Neuroendocrine effects

  7h

• Empathy and social behavior

  7h

• Physiological effects of methylphenidate, modafinil, and MDMA

  7h

• Genetic Polymorphisms

  1 day (assessed once after study completion)

Study Arms (1)

Methylphenidate, Modafinil, MDMA, Placebo

OTHER

Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but four treatment conditions in the same subject.

Drug: Methylphenidate; Drug: Modafinil; Drug: MDMA; Drug: Placebo

Interventions

Methylphenidate DRUG

60mg per os, single dose

Also known as: Ritalin, Concerta, Medikinet, Focalin

Methylphenidate, Modafinil, MDMA, Placebo

Modafinil DRUG

600mg per os, single dose

Also known as: Modasomil

Methylphenidate, Modafinil, MDMA, Placebo

MDMA DRUG

125mg per os, single dose

Also known as: 3,4-Methylenedioxymethamphethamine, Ecstasy

Methylphenidate, Modafinil, MDMA, Placebo

Placebo DRUG

per os

Also known as: capsules containing manitol looking identical to methylphenidate, modafinil, and MDMA

Methylphenidate, Modafinil, MDMA, Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years
• 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 including cannabis 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, as well as during the study day
• Participants must be willing not to drive a traffic vehicle within 24h following MDMA administration
• 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: 18-27kg/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 (\>140/90mmgHg) or Hypotension (SBP\<85mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder. This also includes contraindications for MRI scanning (any type of implants such as heart pacer, insulin-pump, cochlea-implants, heart valve)
• Current or previous psychotic or major affective disorder
• Psychotic or major affective disorder in first-degree relatives
• Prior illicit drug use (except tetrahydrocannabinol (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 30days)
• Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc. )
• Tobacco smoking (regularly \> 10cigarettes / day)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4000, Switzerland

Location

Related Publications (2)

• Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.

  PMID: 29912955 DERIVED

• Dolder PC, Muller F, Schmid Y, Borgwardt SJ, Liechti ME. Direct comparison of the acute subjective, emotional, autonomic, and endocrine effects of MDMA, methylphenidate, and modafinil in healthy subjects. Psychopharmacology (Berl). 2018 Feb;235(2):467-479. doi: 10.1007/s00213-017-4650-5. Epub 2017 May 27.

  PMID: 28551715 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Mood Disorders

Interventions

Methylphenidate; Dexmethylphenidate Hydrochloride; Modafinil; N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Officials

• Matthias E Liechti, MD, MAS

  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: September 23, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

CH (1)