Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)

NCT01136278 | Completed Phase 1 DMC

• 1 other identifier: EK 353/09
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determinate the effect of a pre-treatment with centrally acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that clonidine will attenuate the subjective and cardiovascular response to MDMA.

Conditions

Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders

Keywords

MDMA; norepinephrine; alpha2 receptor; Ecstasy; stimulant

Outcome Measures

Primary Outcomes (1)

• Effect of clonidine on the subjective response to MDMA

  24 h

Secondary Outcomes (5)

• Effect of clonidine on cardiovascular effects of MDMA

  8 h

• Effect of clonidine on pharmacokinetics of MDMA

  8 h

• Effect of MDMA on clonidine pharmacokinetics

  8 h

• Tolerability of MDMA and clonidine

  8 h

• Effect of clonidine on neuroendocrine responses to MDMA

  8 h

Other Outcomes (1)

• Genetic polymorphisms

  assessed after study completion

Study Arms (1)

clonidine, MDMA, 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: Clonidine; Drug: placebo

Interventions

3,4-Methylenedioxymethamphetamine DRUG

125 mg, single dose

Also known as: MDMA, Ecstasy

clonidine, MDMA, placebo

Clonidine DRUG

150 μg per os

clonidine, MDMA, placebo

placebo DRUG

capsules identical to MDMA or clonidine

clonidine, MDMA, 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 (Tetrahydrocannabinol)-containing 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)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, Basel, 4053, 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, Liechti ME. Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex. Psychopharmacology (Berl). 2012 Dec;224(3):363-76. doi: 10.1007/s00213-012-2761-6. Epub 2012 Jun 15.

  PMID: 22700038 DERIVED

MeSH Terms

Conditions

Mood Disorders; Substance-Related Disorders; Amphetamine-Related Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Clonidine

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthias E Liechti, MD

  Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 3, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

CH (1)