Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)
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|ClinicalTrials.gov Identifier: NCT01386177|
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mood Disorder Substance-Related Disorders Amphetamine-Related Disorders||Drug: 3,4-Methylenedioxymethamphetamine Drug: Doxazosin Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Interactive Effects of Doxazosin and 3,4-Methylenedioxymethamphetamine (MDMA) in Healthy Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: doxazosin, MDMA, placebo
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.
125 mg per os, single dose
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.
Other Name: Cardura
capsules identical to MDMA or doxazosin
- Systolic and diastolic blood pressure (mmHg) during 6 hours [ Time Frame: 6 hours ]
- Subjective effects during 6 hours [ Time Frame: 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).)
- Neuroendocrine plasma levels during 6 hours [ Time Frame: 6 hours ]neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
- MDMA plasma levels during 6 hours [ Time Frame: 6 hours ]
- Genetic polymorphisms [ Time Frame: assessed after study completion ]Effects of MDMA on genetic polymorphisms
- Genetic polymorphisms [ Time Frame: assessed after study completion ]Effects of genetic polymorphisms on the response to MDMA
- Prosocial behavior [ Time Frame: 5 hours ]Effects on prosociality will be assessed by the Social Value Orientation slide-measurement test.
- Empathy [ Time Frame: 5 hours ]Emotional empathy will be assessed by the Multifaceted Empathy Test (MET). Cognitive empathy will be assessed by Facial Emotion Recognition Tests and the MET.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386177
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Matthias E Liechti, MD||University Hospital, Basel, Switzerland|