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 hoursNeuroendocrine 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
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