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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mood Disorder, Substance-Related Disorders, Amphetamine-Related Disorders

Intervention / Treatment
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* Drug: MDMA
* Drug: Pindolol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pindolol, Placebo<br>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<br>* capsule, 1.6 mg/kg body weight, single dose<br>Drug: Pindolol<br>* capsule of 20mg pindolol, single dose 1h before MDMA<br>|
| Other: MDMA, Placebo<br>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<br>* capsule, 1.6 mg/kg body weight, single dose<br>Drug: Pindolol<br>* capsule of 20mg pindolol, single dose 1h before MDMA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of pindolol on subjective response to MDMA |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of pindolol on physiological response to MDMA |  | 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDMA, beta adrenergic, Ecstasy