Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Healthy Clinical Trial

Official title:

Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465685
• Other study ID #: EK 228/11
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2011
• Last updated: January 20, 2016
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 3,4-Methylenedioxymethamphetamine
125 mg per os, single dose
• Methylphenidate
1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose
• Placebo
capsules identical to MDMA or methylphenidate

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective effect during 24 hours	subjective effects are repetitively assessed by standardized questionnaires.	24 hours	No
Secondary	Blood pressure (mmHg)during 10 hours		10 hours	No
Secondary	Neuroendocrine plasma levels during 10 hours	neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone	10 hours	No
Secondary	MDMA plasma levels during 24 hours		24 hours	No
Secondary	Heart rate (beats/min)) during 10 hours		10	No
Secondary	Emotional and cognitive empathy	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.	5 hours	No
Secondary	Prosocial behavior	Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.	5 hours	No
Secondary	Genetic polymorphisms	Effects of genetic polymorphisms on the response to MDMA	assessed after study completion	No

External Links

•   Division of Clinical Pharmacology and Toxicology, University Hospital Basel