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

Sponsor:	University Hospital, Basel, Switzerland
Collaborator:	Heffter Research Institute
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00895804

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 I

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:

MedlinePlus related topics: Club Drugs Drug Abuse Drug Reactions High Blood Pressure Methamphetamine

Drug Information available for: Pindolol N-Methyl-3,4-methylenedioxyamphetamine

U.S. FDA Resources

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

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
Substance-Related Disorders
Mood Disorders
Mental Disorders
Pindolol
N-Methyl-3,4-methylenedioxyamphetamine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Vasodilator Agents
Hallucinogens
Central Nervous System Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012