Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)

Randomised, double-blind, placebo-controlled crossover in 16 healthy volunteers testing carvedilol (50 mg) pre-treatment on the pharmacodynamics and pharmacokinetics of oral MDMA (125 mg).

Target Enrollment
16 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Carvedilol–MDMA crossover

experimental

Within-subject crossover testing carvedilol or placebo given 1 h before MDMA or placebo (4 sessions).

Interventions

  • MDMA125 mg
    via Oral• single dose• 1 doses total

    Oral MDMA 125 mg single dose.

  • Compound50 mg
    via Oral• single dose• 1 doses total

    Carvedilol 50 mg oral given 1 h before MDMA or placebo.

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo capsules identical to MDMA or carvedilol.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion 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

  • 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.)

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2011-01-01
    End: 2011-01-05
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland

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