Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

NCT01957293 | Completed Phase 2 DMC

• 1 other identifier: 2013DR2134
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Memory Functions

Outcome Measures

Primary Outcomes (2)

• Change of emotional memory functions under Salbutamol

  memory tests

  two testing days within 10 days

• Change of episodic memory functions under Salbutamol

  memory tests

  two testing days within10 days

Secondary Outcomes (2)

• Change of emotional state under salbutamol

  Two testing days within 10 days

• change of attention functions under salbutamol

  two testing days within 10 days

Study Arms (2)

Salbutamol

EXPERIMENTAL

Drug: Salbutamol

Sugar Syrup

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Salbutamol DRUG

single oral administration, 4 mg

Salbutamol

Placebo DRUG

single oral administration

Sugar Syrup

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

University of Basel, Division of Cognitive neuroscience

Basel, 4055, Switzerland

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Dominique de Quervain, Prof. MD

  University of Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of teh Division of Cognitive Neuroscience

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-02

Locations

CH (1)