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

Phase 1

Completed

• Conditions: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
• Interventions: Drug: MDMA; Drug: Pindolol

• Registration Number: NCT00895804
• Lead Sponsor: University Hospital, Basel, Switzerland

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 Timeline

• Study Start: 2001-06
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-12
• Last Update Posted: 2009-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pindolol, Placebo	MDMA	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.
Pindolol, Placebo	Pindolol	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.
MDMA, Placebo	MDMA	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.
MDMA, Placebo	Pindolol	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.

Primary Outcome Measures

Name	Time	Method
Effect of pindolol on subjective response to MDMA	24h

Secondary Outcome Measures

Name	Time	Method
Effect of pindolol on physiological response to MDMA	24h

Trial Locations

Locations (1)

Heffter Research Center, University Hospital of Psychiatry; 🇨🇭 Zurich, Switzerland