Clinical TrialHealthy VolunteersMDMACompleted

Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

This randomised, double-blind, placebo-controlled crossover trial (n=16) investigated the pharmacological interaction between pindolol (20 mg) and MDMA (1.6 mg/kg) in healthy male volunteers, specifically examining effects on cardiovascular function and adverse reactions.

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

Detailed Description

Double-blind, randomised, crossover study in 16 healthy male volunteers testing interactive effects of pindolol (20 mg) given 1 h before a single oral dose of MDMA (1.6 mg/kg).

Outcomes included heart rate, blood pressure, body temperature and adverse-effect profile; procedures included clinical monitoring, ECG and laboratory safety assessments.

Study Protocol

Preparation

sessions

Dosing

2 sessions
360 min each

Integration

sessions

Study Arms & Interventions

MDMA ± Pindolol

experimental

Within-subject crossover comparing MDMA with and without pindolol.

Interventions

  • MDMA1.6 mg/kg
    via Oral• single dose

    Single dose MDMA 1.6 mg/kg.

  • Compound20 mg
    via Oral• single dose

    Pindolol 20 mg given 1 h before MDMA.

Participants

Ages
18 – 45
Sexes
male

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 after midnight of the evening before the study session.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • 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 THC-containing products) more than 5 times or any time within the previous 2 months.
  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2001-06-01
    End: 2002-03-01
  • Compound
    MDMA
  • Topic
    Healthy Volunteers

Locations

Heffter Research Center, University Hospital of Psychiatry — Zurich, Canton of Zurich, Switzerland

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