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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2009

Last Updated Date

June 12, 2009

Start Date ^ICMJE

June 2001

Primary Completion Date

March 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00895804 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Mood Disorder
Substance-Related Disorders
Amphetamine-Related Disorders

Intervention ^ICMJE

Drug: MDMA
capsule, 1.6 mg/kg body weight, single dose
Drug: Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA

Study Arm (s)

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.
Interventions:
- Drug: MDMA
- Drug: Pindolol
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.
Interventions:
- Drug: MDMA
- Drug: Pindolol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2002

Primary Completion Date

March 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00895804

Other Study ID Numbers ^ICMJE

E-003/2001

Has Data Monitoring Committee

Yes

Responsible Party

Matthias E. Liechti, Universtity Hospital Basel

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Heffter Research Institute

Investigators ^ICMJE

Principal Investigator:

Matthias E Liechti, MD

University Hospital, Basel, Switzerland

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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