Emotional Effects of Methylphenidate and MDMA in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01465685|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : January 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: 3,4-Methylenedioxymethamphetamine Drug: Methylphenidate Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Emotional Effects of Methylphenidate and MDMA in Healthy Subjects|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Experimental: MDMA, methylphenidate, placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
125 mg per os, single dose
1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose
capsules identical to MDMA or methylphenidate
- Subjective effect during 24 hours [ Time Frame: 24 hours ]subjective effects are repetitively assessed by standardized questionnaires.
- Blood pressure (mmHg)during 10 hours [ Time Frame: 10 hours ]
- Neuroendocrine plasma levels during 10 hours [ Time Frame: 10 hours ]neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
- MDMA plasma levels during 24 hours [ Time Frame: 24 hours ]
- Heart rate (beats/min)) during 10 hours [ Time Frame: 10 ]
- Emotional and cognitive empathy [ Time Frame: 5 hours ]
emotional empathy is going to be assessed by the Multifaceted Empathy Test (MET).
cognitive empathy is going to be assessed by the Facial Emotion Recognition Task and the MET.
- Prosocial behavior [ Time Frame: 5 hours ]Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.
- Genetic polymorphisms [ Time Frame: assessed after study completion ]Effects of genetic polymorphisms on the response to MDMA
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): NCT01465685
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4000|
|Principal Investigator:||Matthias E Liechti, MD||University Hospital, Basel, Switzerland|