Pharmacological Interaction Between Carvedilol... — Clinical Trial Details

This randomized, quadruple-blind, placebo-controlled crossover study in healthy adults evaluates whether carvedilol (50 mg) attenuates the cardiovascular and subjective effects of a single oral MDMA dose (125 mg).

Each participant completes four experimental sessions in which carvedilol or placebo is given 1 hour before MDMA or placebo; subjective and cardiovascular responses are measured repeatedly and plasma is collected for pharmacokinetics and pharmacodynamics.

Primary hypothesis: carvedilol will significantly reduce the blood pressure response to MDMA; secondary outcomes include heart rate, subjective effects, and PK measures.

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-degree 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.)

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Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)

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Related Publications

Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex

Integration

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Carvedilol–MDMA crossover

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Inclusion Criteria

Exclusion Criteria

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