Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
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|ClinicalTrials.gov Identifier: NCT01951508|
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : January 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Substance-related Disorder Mood Disorder||Drug: Methylphenidate Drug: Modafinil Drug: MDMA Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Methylphenidate, Modafinil, MDMA, Placebo
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.
60mg per os, single dose
600mg per os, single dose
Other Name: Modasomil
125mg per os, single dose
Other Name: capsules containing manitol looking identical to methylphenidate, modafinil, and MDMA
- Effect on amygdala and striatum BOLD signal responses to emotional stimuli [ Time Frame: 1.5h ]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.
- Effects on cognitive performance and associated BOLD signal changes in frontal areas [ Time Frame: 1.5h ]Functional magnetic resonance (MR) images measuring BOLD (blood oxygen level dependency)activity while subjects perform a response inhibition/attention task.
- Subjective effects [ Time Frame: 7h ]repeated assessment of subjective effects with validated, standardized questionnaires
- Neuroendocrine effects [ Time Frame: 7h ]neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, copeptin
- Empathy and social behavior [ Time Frame: 7h ]
assessment of cognitive and emotional empathy (empathy is going to be assessed by the Multifaceted Empathy Test (MET)), facial emotion recognition (assessed by the Facial Emotion Recognition Task (FERT)), and prosocial behavior (assessed with the Social Value Orientation Test (SVO)).
, as well as of prosocial behaviour
- Physiological effects of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]repeated assessment of blood pressure (mmHg) , heart rate (bpm), body temperature, and pupillary function
- Genetic Polymorphisms [ Time Frame: 1 day (assessed once after study completion) ]Effects of genetic polymorphisms on the response to methylphenidate, modafinil, and MDMA
- Pharmacokinetics of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship
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): NCT01951508
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4000|
|Principal Investigator:||Matthias E Liechti, MD, MAS||University Hospital, Basel, Switzerland|