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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

May 7, 2009
June 12, 2009
June 2001
March 2002   (final data collection date for primary outcome measure)
Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895804 on ClinicalTrials.gov Archive Site
Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Mood Disorder
  • Substance-Related Disorders
  • Amphetamine-Related Disorders
  • Drug: MDMA
    capsule, 1.6 mg/kg body weight, single dose
  • Drug: Pindolol
    capsule of 20mg pindolol, single dose 1h before MDMA
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2002
March 2002   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00895804
E-003/2001
Yes
Matthias E. Liechti, Universtity Hospital Basel
University Hospital, Basel, Switzerland
Heffter Research Institute
Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
June 2009

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