Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

1. To evaluate the effects of a single oral (80 mg) dose of propranolol on the encoding of emotional pictures as assessed by peripheral physiological and electrocortical parameters in a healthy population.

2. To evaluate the effects of a single oral (80 mg) dose of propranolol on the retrieval of emotional pictures as assessed by electrocortical parameters in a healthy population.

3. To evaluate correlations between behavioral data and psychophysiological parameters.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• age: 18 - 35 years

• sex: male

• ethnic origin: Caucasian

• body weight: between 19 kg/m² and 27 kg/m² [calculated from weight (kg)/height2 (m2)]

• good health as evidenced by the results of the clinical examination, ECG, and laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state

• written informed consent

Exclusion Criteria:

• obstructive lung disease (e.g. bronchial asthma)

• peripheral arterial circulatory disturbance

• any disturbance of impulse formation and conduction (e.g. sick sinus syndrome, SA or AV-blockade)

• bradycardia (< 50 beats/min)

• hypotension (systolic pressure < 90 mmHg)

• existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics

• existing hepatic and renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics

• existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics

• existing or further diseases of the CNS, especially epilepsy

• acute or chronic diseases which could affect absorption or metabolism

• history of any serious psychological disorder

• taking MAO inhibitors

• drug or alcohol dependence

• positive drug or alcohol screening

• smokers

• positive anti-HIV-test, HBs-Ag-test or anti-HCV-test

• volunteers who are on a diet which could affect the pharmacokinetics of the drug

• heavy tea or coffee drinkers (more than 1L per day)

• volunteers suspected or known not to follow instructions

• volunteers working night shifts

• volunteers who are in stressful periods or had undergone major life changes (e.g. death of a close family member in the past year)

• volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

• participation in another clinical trial during this study

• less than 14 days after last acute disease

• any systemically available medication within 4 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites

• repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin)

• repeated use of drugs during the last 2 weeks prior to the intended first administration which affect absorption (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists)

• known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparation

• subjects with severe allergies or multiple drug allergies