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

NCT ID: NCT00895804

Last Updated: 2009-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2002-03-31

Brief Summary

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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

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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.

Conditions

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Mood Disorder Substance-Related Disorders Amphetamine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

MDMA

Intervention Type DRUG

capsule, 1.6 mg/kg body weight, single dose

Pindolol

Intervention Type DRUG

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.

Group Type OTHER

MDMA

Intervention Type DRUG

capsule, 1.6 mg/kg body weight, single dose

Pindolol

Intervention Type DRUG

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

Interventions

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MDMA

capsule, 1.6 mg/kg body weight, single dose

Intervention Type DRUG

Pindolol

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heffter Research Institute

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Universtity Hospital Basel

Principal Investigators

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Matthias E Liechti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Heffter Research Center, University Hospital of Psychiatry

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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E-003/2001

Identifier Type: -

Identifier Source: org_study_id

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