Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)
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: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
Intervention: 3,4-Methylenedioxymethamphetamine (Drug); Doxazosin (Drug); placebo (Drug)
Phase: Phase 1
Sponsored by: University Hospital, Basel, Switzerland
Official(s) and/or principal investigator(s):
Matthias E Liechti, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland
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.
Official title: Interactive Effects of Doxazosin and 3,4-Methylenedioxymethamphetamine (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: Systolic and diastolic blood pressure (mmHg) during 6 hours
Subjective effects during 6 hours
Neuroendocrine plasma levels during 6 hours
MDMA plasma levels during 6 hours
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.
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- 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
- 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 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
Locations and Contacts
University Hospital Basel, Basel 4031, Switzerland
Starting date: July 2011
Last updated: January 24, 2013