Status:
COMPLETED
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Heffter Research Institute
Conditions:
Mood Disorder
Substance-Related Disorders
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 cerebr...
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-contro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2002
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00895804
Start Date
June 1 2001
End Date
March 1 2002
Last Update
June 15 2009
Active Locations (1)
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1
Heffter Research Center, University Hospital of Psychiatry
Zurich, Canton of Zurich, Switzerland, 8032