Effects of MDMA and Methylphenidate on Social Cognition
Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Cognition
Intervention: 3,4-Methylenedioxymethamphetamine (Drug); Methylphenidate (Drug); Placebo (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s): Matthias E Liechti, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland
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.
Clinical Details
Official title: Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Effects on social cognition (emotion recognition and empathy)
Secondary outcome: Blood pressure (mmHg) and heart rate (beats per min)Subjective effects Neuroendocrine plasma levels Drug plasma concentration
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.)
Locations and Contacts
University Hospital Basel, Basel 4031, Switzerland
Additional Information
Starting date: August 2012
Last updated: April 25, 2013
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