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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01386177
Other study ID # EK 65/11
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2011
Est. completion date January 2012

Study information

Verified date December 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 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.)

Study Design


Intervention

Drug:
3,4-Methylenedioxymethamphetamine
125 mg per os, single dose
Doxazosin
3 days (-64h) before MDMA: 4 mg doxazosin per os. 2 days (-40h) before MDMA: 8 mg doxazosin per os. 1 day (-16h) before MDMA: 8 mg doxazosin per os.
placebo
capsules identical to MDMA or doxazosin

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Prosocial behavior Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test. 5 hours
Other Empathy Emotional empathy will be assessed by the Multifaceted Empathy Test (MET). Cognitive empathy will be assessed by Facial Emotion Recognition Tests and the MET. 5 hours
Primary Systolic and diastolic blood pressure (mmHg) during 6 hours 6 hours
Secondary Subjective effects during 6 hours subjective effects are going to be assessed by various standardized questionnaires (e.g. visual analogue scales (VAS), the 5 dimension Altered State of consciousness questionnaire, or the adjective mood rating scale (AMRS).) 6 hours
Secondary Neuroendocrine plasma levels during 6 hours neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone 6 hours
Secondary MDMA plasma levels during 6 hours 6 hours
Secondary Genetic polymorphisms Effects of MDMA on genetic polymorphisms assessed after study completion
Secondary Genetic polymorphisms Effects of genetic polymorphisms on the response to MDMA assessed after study completion
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