Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)

Randomised, double-blind, placebo-controlled crossover Phase I study (n=16) testing pre-treatment with doxazosin versus placebo on physiological and subjective responses to a single oral MDMA 125 mg dose in healthy volunteers.

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

Detailed Description

This randomized double-blind placebo-controlled crossover study in 16 healthy volunteers tests whether alpha1-adrenergic blockade with doxazosin attenuates the cardiovascular and subjective effects of MDMA (single oral 125 mg).

Doxazosin is given as a pre-treatment regimen across three days before each MDMA session; subjective and cardiovascular measures are recorded repeatedly and plasma samples collected for pharmacokinetics.

Primary outcome focuses on blood pressure response; secondary measures include heart rate, subjective effects and adverse events.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Doxazosin / MDMA / placebo

experimental

Randomised double-blind placebo-controlled crossover with four experimental sessions; all conditions tested within subjects.

Interventions

  • MDMA125 mg
    via Oral• single dose

    Single oral MDMA 125 mg.

  • Compound
    via Oral• pre-treatment

    Doxazosin regimen: 3 days before (-64h) 4 mg PO; 2 days before (-40h) 8 mg PO; 1 day before (-16h) 8 mg PO.

  • Placebo
    via Oral• single dose

    Capsules identical to MDMA or doxazosin.

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-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 Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2011-01-07
    End: 2012-01-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Switzerland

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