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Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)

Information source: University Hospital, Basel, Switzerland
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders

Intervention: 3,4-Methylenedioxymethamphetamine (Drug); Doxazosin (Drug); placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University Hospital, Basel, Switzerland

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

Overall contact:
Matthias E Liechti, MD, Phone: +41 61 265 88 68, Email: liechtim@uhbs.ch

Summary

The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"). The investigators hypothesize that doxazosin will attenuate the cardiovascular and subjective response to MDMA.

Clinical Details

Official title: Interactive Effects of Doxazosin and 3,4-Methylenedioxymethamphetamine (MDMA) in Healthy Subjects

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

Primary outcome: Systolic and diastolic blood pressure (mmHg) during 6 hours

Secondary outcome:

Subjective effects during 6 hours

Neuroendocrine plasma levels during 6 hours

MDMA plasma levels during 6 hours

Detailed description: 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE release is thought to mediate the cardiovascular effects of MDMA and may also contribute to its psychostimulant effects. However, the functional role of adrenergic postsynaptic receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear. To determine the role of alpha-adrenergic receptors in the response to MDMA in humans the investigators test the effects of the alpha1-receptor blocker doxazosin on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. doxazosin 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 doxazosin will significantly reduce the blood pressure response to 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 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

Matthias E Liechti, MD, Phone: +41 61 265 88 68, Email: liechtim@uhbs.ch

University Hospital Basel, Basel 4031, Switzerland; Recruiting
Matthias E Liechti, MD, Phone: +41 61 265 88 68, Email: liechtim@uhbs.ch
Cedric M Hysek, MSc, Phone: +41 61 556 54 37, Email: hysekc@uhbs.ch
Matthias E Liechti, MD, Principal Investigator
Cedric M Hysek, MSc, Sub-Investigator
Additional Information

Psychopharmacology Research Group

Starting date: July 2011
Last updated: August 8, 2011

Page last updated: December 08, 2011

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