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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895804
• Other study ID #: E-003/2001
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: June 12, 2009
• Start date: June 2001
• Est. completion date: March 2002

Study information

• Verified date: June 2009
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Amphetamine-Related Disorders
• Disease
• Mood Disorder
• Mood Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Switzerland	Heffter Research Center, University Hospital of Psychiatry	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Heffter Research Institute

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of pindolol on subjective response to MDMA		24h	No
Secondary	Effect of pindolol on physiological response to MDMA		24h	No