Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
NCT ID: NCT00895804
Last Updated: 2009-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2001-06-30
2002-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
MDMA
capsule, 1.6 mg/kg body weight, single dose
Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA
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.
MDMA
capsule, 1.6 mg/kg body weight, single dose
Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA
Interventions
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MDMA
capsule, 1.6 mg/kg body weight, single dose
Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Heffter Research Institute
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Universtity Hospital Basel
Principal Investigators
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Matthias E Liechti, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Heffter Research Center, University Hospital of Psychiatry
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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E-003/2001
Identifier Type: -
Identifier Source: org_study_id
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