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Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: 3,4-Methylenedioxymethamphetamine (Drug); Methylphenidate (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University Hospital, Basel, Switzerland

Official(s) and/or principal investigator(s):
Matthias E Liechti, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland

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.

Clinical Details

Official title: Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

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

Primary outcome: Subjective effect during 24 hours

Secondary outcome:

Blood pressure (mmHg)during 10 hours

Neuroendocrine plasma levels during 10 hours

MDMA plasma levels during 24 hours

Heart rate (beats/min)) during 10 hours

Emotional and cognitive empathy

Prosocial behavior

Genetic polymorphisms

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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 (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.)

Locations and Contacts

University Hospital Basel, Basel, Basel-Stadt 4000, Switzerland
Additional Information

Link Text: Division of Clinical Pharmacology and Toxicology, University Hospital Basel

Starting date: December 2011
Last updated: August 27, 2013

Page last updated: August 23, 2015

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