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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00895804
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : June 15, 2009
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by:
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE May 7, 2009
First Posted Date  ICMJE May 8, 2009
Last Update Posted Date June 15, 2009
Study Start Date  ICMJE June 2001
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Official Title  ICMJE Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Mood Disorder
  • Substance-Related Disorders
  • Amphetamine-Related Disorders
Intervention  ICMJE
  • Drug: MDMA
    capsule, 1.6 mg/kg body weight, single dose
  • Drug: Pindolol
    capsule of 20mg pindolol, single dose 1h before MDMA
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2009)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2002
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00895804
Other Study ID Numbers  ICMJE E-003/2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Matthias E. Liechti, Universtity Hospital Basel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Heffter Research Institute
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date June 2009

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