Effects of MDMA and Methylphenidate on Social Cognition
This study has been completed.
Sponsor:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01616407
First received: June 7, 2012
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Social Cognition |
Drug: 3,4-Methylenedioxymethamphetamine Drug: Methylphenidate Drug: Placebo |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition |
Resource links provided by NLM:
Further study details as provided by University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- Effects on social cognition (emotion recognition and empathy) [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure (mmHg) and heart rate (beats per min) [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
- Subjective effects [ Time Frame: 7 hours ] [ Designated as safety issue: No ]subjective effects are repetitively assessed by standardized questionnaires
- Neuroendocrine plasma levels [ Time Frame: 7 hours ] [ Designated as safety issue: No ]neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone
- Drug plasma concentration [ Time Frame: 7 hours ] [ Designated as safety issue: No ]The plasma concentration of MDMA and MPH is repetitively assessed.
Other Outcome Measures:
- Genetic polymorphisms [ Time Frame: assessed after study completion ] [ Designated as safety issue: No ]Effects of genetic polymorphisms on the response to MDMA
| Enrollment: | 30 |
| Study Start Date: | August 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: 3,4-Methylenedioxymethamphetamine
75 mg per os, single dose
Other Names:
Drug: Methylphenidate
40 mg per os, single dose
Other Names:
Drug: Placebo
capsules identical to MDMA or methylphenidate but containing no active drug
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616407
Locations
| Switzerland | |
| University Hospital Basel | |
| Basel, Switzerland, 4031 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
| Principal Investigator: | Matthias E Liechti, MD | University Hospital, Basel, Switzerland |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01616407 History of Changes |
| Other Study ID Numbers: | EK 382/11, 2012DR1018 |
| Study First Received: | June 7, 2012 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
Effects of psychostimulants on emotion recognition and empathy |
Additional relevant MeSH terms:
|
Methylphenidate N-Methyl-3,4-methylenedioxyamphetamine Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Hallucinogens Psychotropic Drugs Serotonin Agents Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 21, 2013