Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects (Salmon-Basel)

December 15, 2014 updated by: Prof. Dominique de Quervain, MD
Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salbutamol
Drug: Salbutamol
single oral administration, 4 mg
Placebo Comparator: Sugar Syrup
Drug: Placebo
single oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of emotional memory functions under Salbutamol
Time Frame: two testing days within 10 days
memory tests
two testing days within 10 days
Change of episodic memory functions under Salbutamol
Time Frame: two testing days within10 days
memory tests
two testing days within10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of emotional state under salbutamol
Time Frame: Two testing days within 10 days
questionnaires
Two testing days within 10 days
change of attention functions under salbutamol
Time Frame: two testing days within 10 days
attention tests
two testing days within 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dominique de Quervain, MD

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

  • Study Director: Dominique de Quervain, Prof. MD, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013DR2134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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