- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616407
Effects of MDMA and Methylphenidate on Social Cognition
December 10, 2018 updated by: University Hospital, Basel, Switzerland
Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4031
- University Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MDMA, methylphenidate, placebo
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.
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75 mg per os, single dose
Other Names:
40 mg per os, single dose
Other Names:
capsules identical to MDMA or methylphenidate but containing no active drug
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects on social cognition (emotion recognition and empathy)
Time Frame: 7 hours
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7 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure (mmHg) and heart rate (beats per min)
Time Frame: 7 hours
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7 hours
|
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Subjective effects
Time Frame: 7 hours
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subjective effects are repetitively assessed by standardized questionnaires
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7 hours
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Neuroendocrine plasma levels
Time Frame: 7 hours
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neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone
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7 hours
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Drug plasma concentration
Time Frame: 7 hours
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The plasma concentration of MDMA and MPH is repetitively assessed.
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7 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic polymorphisms
Time Frame: assessed after study completion
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Effects of genetic polymorphisms on the response to MDMA
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assessed after study completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
June 7, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (ESTIMATE)
June 11, 2012
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2018
Last Update Submitted That Met QC Criteria
December 10, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Hallucinogens
- Adrenergic Uptake Inhibitors
- Methylphenidate
- N-Methyl-3,4-methylenedioxyamphetamine
Other Study ID Numbers
- EK 382/11
- 2012DR1018 (OTHER: Swissmedic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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