Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT01465685

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 3,4-Methylenedioxymethamphetamine Drug: Methylphenidate Drug: Placebo	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

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 :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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 two (actually 4) treatment conditions in the same subject.	Drug: 3,4-Methylenedioxymethamphetamine 125 mg per os, single dose Other Names: MDMA ecstasy Drug: Methylphenidate 1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose Other Names: Ritalin Concerta Drug: Placebo capsules identical to MDMA or methylphenidate

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 two (actually 4) treatment conditions in the same subject.

Drug: 3,4-Methylenedioxymethamphetamine

125 mg per os, single dose

Other Names:

MDMA

ecstasy

Drug: Methylphenidate

1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose

Other Names:

Ritalin

Concerta

Drug: Placebo

capsules identical to MDMA or methylphenidate

Outcome Measures

Primary Outcome Measures

Subjective effect during 24 hours [24 hours]
subjective effects are repetitively assessed by standardized questionnaires.

Secondary Outcome Measures

Blood pressure (mmHg)during 10 hours [10 hours]
Neuroendocrine plasma levels during 10 hours [10 hours]
neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
MDMA plasma levels during 24 hours [24 hours]
Heart rate (beats/min)) during 10 hours [10]
Emotional and cognitive empathy [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 [5 hours]
Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.
Genetic polymorphisms [assessed after study completion]
Effects of genetic polymorphisms on the response to MDMA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 (tetrahydrocannabinol) 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.)