Overview

Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Treatments:
Clonidine
N-Methyl-3,4-methylenedioxyamphetamine
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 (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.)