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

Primary Purpose

Mood Disorder, Substance-Related Disorders, Amphetamine-Related Disorders

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
MDMA
Pindolol
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mood Disorder focused on measuring MDMA, beta adrenergic, Ecstasy

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Heffter Research Center, University Hospital of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pindolol, Placebo

MDMA, Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effect of pindolol on subjective response to MDMA

Secondary Outcome Measures

Effect of pindolol on physiological response to MDMA

Full Information

First Posted
May 7, 2009
Last Updated
June 12, 2009
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Heffter Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00895804
Brief Title
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Official Title
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Heffter Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorder, Substance-Related Disorders, Amphetamine-Related Disorders
Keywords
MDMA, beta adrenergic, Ecstasy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pindolol, Placebo
Arm Type
Other
Arm Description
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.
Arm Title
MDMA, Placebo
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MDMA
Intervention Description
capsule, 1.6 mg/kg body weight, single dose
Intervention Type
Drug
Intervention Name(s)
Pindolol
Intervention Description
capsule of 20mg pindolol, single dose 1h before MDMA
Primary Outcome Measure Information:
Title
Effect of pindolol on subjective response to MDMA
Time Frame
24h
Secondary Outcome Measure Information:
Title
Effect of pindolol on physiological response to MDMA
Time Frame
24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias E Liechti, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heffter Research Center, University Hospital of Psychiatry
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

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

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