Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
Intervention: MDMA (Drug); Pindolol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s):
Matthias E Liechti, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland
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.
Clinical Details
Official title: Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Effect of pindolol on subjective response to MDMA
Secondary outcome: Effect of pindolol on physiological response to 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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
Heffter Research Center, University Hospital of Psychiatry, Zurich 8032, Switzerland
Additional Information
Starting date: June 2001
Last updated: June 12, 2009
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