Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

Memory Functions Clinical Trial

— Salmon-Basel  

Official title:

Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957293
• Other study ID #: 2013DR2134
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2013
• Last updated: December 15, 2014
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis -

Exclusion Criteria:

Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Memory Functions

Intervention

Drug:
• Salbutamol
single oral administration, 4 mg
• Placebo
single oral administration

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive neuroscience	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of emotional memory functions under Salbutamol	memory tests	two testing days within 10 days	No
Primary	Change of episodic memory functions under Salbutamol	memory tests	two testing days within10 days	No
Secondary	Change of emotional state under salbutamol	questionnaires	Two testing days within 10 days	No
Secondary	change of attention functions under salbutamol	attention tests	two testing days within 10 days	No