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

This study has been completed.
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00895804
First received: May 7, 2009
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Mood Disorder
Substance-Related Disorders
Amphetamine-Related Disorders
Drug: MDMA
Drug: Pindolol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2001
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pindolol, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
Drug: MDMA
capsule, 1.6 mg/kg body weight, single dose
Drug: Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA
MDMA, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
Drug: MDMA
capsule, 1.6 mg/kg body weight, single dose
Drug: Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895804

Locations
Switzerland
Heffter Research Center, University Hospital of Psychiatry
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Heffter Research Institute
Investigators
Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Matthias E. Liechti, Universtity Hospital Basel
ClinicalTrials.gov Identifier: NCT00895804     History of Changes
Other Study ID Numbers: E-003/2001
Study First Received: May 7, 2009
Last Updated: June 12, 2009
Health Authority: Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Basel, Switzerland:
MDMA
beta adrenergic
Ecstasy

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Disease
Mood Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
N-Methyl-3,4-methylenedioxyamphetamine
Pindolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Adrenergic Uptake Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Central Nervous System Agents
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014