Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

NCT01465685 | Completed Phase 1 DMC

• 1 other identifier: EK 228/11
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

MDMA; pharmacokinetics; pharmacodynamics; emotions; Mechanism of action of MDMA; Interaction study; Effect of MDMA and methylphenidate on emotions

Outcome Measures

Primary Outcomes (1)

• Subjective effect during 24 hours

  subjective effects are repetitively assessed by standardized questionnaires.

  24 hours

Secondary Outcomes (7)

• Blood pressure (mmHg)during 10 hours

  10 hours

• Neuroendocrine plasma levels during 10 hours

  10 hours

• MDMA plasma levels during 24 hours

  24 hours

• Heart rate (beats/min)) during 10 hours

  10

• Emotional and cognitive empathy

  5 hours

Study Arms (1)

MDMA, methylphenidate, placebo

EXPERIMENTAL

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; Drug: Methylphenidate; Drug: Placebo

Interventions

3,4-Methylenedioxymethamphetamine DRUG

125 mg per os, single dose

Also known as: MDMA, ecstasy

MDMA, methylphenidate, placebo

Methylphenidate DRUG

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

Also known as: Ritalin, Concerta

MDMA, methylphenidate, placebo

Placebo DRUG

capsules identical to MDMA or methylphenidate

MDMA, methylphenidate, placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4000, Switzerland

Location

Related Publications (2)

• Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.

  PMID: 29912955 DERIVED

• Hysek CM, Simmler LD, Schillinger N, Meyer N, Schmid Y, Donzelli M, Grouzmann E, Liechti ME. Pharmacokinetic and pharmacodynamic effects of methylphenidate and MDMA administered alone or in combination. Int J Neuropsychopharmacol. 2014 Mar;17(3):371-81. doi: 10.1017/S1461145713001132. Epub 2013 Oct 8.

  PMID: 24103254 DERIVED

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Methylphenidate

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthias E Liechti, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 7, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

CH (1)