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Completed

NCT Number: NCT00895804

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

MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Heffter Research Center, University Hospital of Psychiatry

Zurich, Canton of Zurich, 8032, Switzerland

About this study

We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MDMA

Drug

capsule, 1.6 mg/kg body weight, single dose

Pindolol

Drug

capsule of 20mg pindolol, single dose 1h before MDMA

Primary outcomes

  1. Effect of pindolol on subjective response to MDMA

    Time frame: 24h

Secondary outcomes

  1. Effect of pindolol on physiological response to MDMA

    Time frame: 24h

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Heffter Research Institute

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 8, 2009
Registry last updated
Jun 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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