Emotional Effects of Methylphenidate and MDMA in Healthy Subjects
This study compares the interactive emotional/subjective effects of single doses of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") and methylphenidate, a dopamine (DA) and norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to determine the role of transporter mediated DA and NE release in the subjective response to MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the subjective response to MDMA.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Emotional Effects of Methylphenidate and MDMA in Healthy Subjects|
- Subjective effect during 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]subjective effects are repetitively assessed by standardized questionnaires.
- Blood pressure (mmHg)during 10 hours [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
- Neuroendocrine plasma levels during 10 hours [ Time Frame: 10 hours ] [ Designated as safety issue: No ]neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
- MDMA plasma levels during 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Heart rate (beats/min)) during 10 hours [ Time Frame: 10 ] [ Designated as safety issue: No ]
- Emotional and cognitive empathy [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.
- Genetic polymorphisms [ Time Frame: assessed after study completion ] [ Designated as safety issue: No ]Effects of genetic polymorphisms on the response to MDMA
|Study Start Date:||December 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
Other Names:Drug: Methylphenidate
1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose
Other Names:Drug: Placebo
capsules identical to MDMA or methylphenidate
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE). 5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is involved in the cardiovascular and psychostimulant effects of MDMA. DA is also likely to be involved in the rewarding and reinforcing effects of drugs of abuse. However, the functional role of DA in the subjective effects of MDMA in humans is largely unclear. To determine the role of the DA transporter (DAT) in the response to MDMA in humans the investigators test the effects of the DA and NE transporter blocker methylphenidate on the subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. methylphenidate or placebo will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that methylphenidate will significantly reduce the subjective effects of MDMA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465685
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4000|
|Principal Investigator:||Matthias E Liechti, MD||University Hospital, Basel, Switzerland|