Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
This study has been completed.
Sponsor:
University Hospital, Basel, Switzerland
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mood Disorder Substance-Related Disorders Amphetamine-Related Disorders |
Drug: MDMA Drug: Pindolol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | June 2001 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: MDMA
capsule, 1.6 mg/kg body weight, single dose
Drug: 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.
|
Drug: MDMA
capsule, 1.6 mg/kg body weight, single dose
Drug: Pindolol
capsule of 20mg pindolol, single dose 1h before MDMA
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895804
Locations
| Switzerland | |
| Heffter Research Center, University Hospital of Psychiatry | |
| Zurich, Switzerland, 8032 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Heffter Research Institute
Investigators
| Principal Investigator: | Matthias E Liechti, MD | University Hospital, Basel, Switzerland |
More Information
No publications provided
| Responsible Party: | Matthias E. Liechti, Universtity Hospital Basel |
| ClinicalTrials.gov Identifier: | NCT00895804 History of Changes |
| Other Study ID Numbers: | E-003/2001 |
| Study First Received: | May 7, 2009 |
| Last Updated: | June 12, 2009 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Federal Office of Public Health |
Keywords provided by University Hospital, Basel, Switzerland:
|
MDMA beta adrenergic Ecstasy |
Additional relevant MeSH terms:
|
Amphetamine-Related Disorders Substance-Related Disorders Mood Disorders Mental Disorders Pindolol N-Methyl-3,4-methylenedioxyamphetamine Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Serotonin Antagonists Serotonin Agents Vasodilator Agents Hallucinogens Central Nervous System Agents Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013