Healthy | Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
Healthy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Exclusion Criteria: - 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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Methylphenidate60mg per os, single dose
Drug:Modafinil600mg per os, single dose
Drug:MDMA125mg per os, single dose
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Methylphenidate, Modafinil, MDMA, PlaceboCross-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.
Start Date: October 2013
Completed Date: December 2014
Phase: Early Phase 1
Primary Outcome: Effect on amygdala and striatum BOLD signal responses to emotional stimuli
Secondary Outcome: Subjective effects
Study sponsors, principal investigator, and references
Principal Investigator: Matthias E Liechti, MD, MAS
Lead Sponsor: University Hospital, Basel, Switzerland