Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01957293
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2013-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2013-09-24', 'studyFirstSubmitQcDate': '2013-09-30', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of emotional memory functions under Salbutamol', 'timeFrame': 'two testing days within 10 days', 'description': 'memory tests'}, {'measure': 'Change of episodic memory functions under Salbutamol', 'timeFrame': 'two testing days within10 days', 'description': 'memory tests'}], 'secondaryOutcomes': [{'measure': 'Change of emotional state under salbutamol', 'timeFrame': 'Two testing days within 10 days', 'description': 'questionnaires'}, {'measure': 'change of attention functions under salbutamol', 'timeFrame': 'two testing days within 10 days', 'description': 'attention tests'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Memory Functions']}, 'descriptionModule': {'briefSummary': 'Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy, 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 -\n\nExclusion Criteria:\n\nAcute 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. -"}, 'identificationModule': {'nctId': 'NCT01957293', 'acronym': 'Salmon-Basel', 'briefTitle': 'Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects', 'orgStudyIdInfo': {'id': '2013DR2134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salbutamol', 'interventionNames': ['Drug: Salbutamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Syrup', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Salbutamol', 'type': 'DRUG', 'description': 'single oral administration, 4 mg', 'armGroupLabels': ['Salbutamol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single oral administration', 'armGroupLabels': ['Sugar Syrup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4055', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel, Division of Cognitive neuroscience', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Dominique de Quervain, Prof. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dominique de Quervain, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Trial Unit, University Hospital Basel, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of teh Division of Cognitive Neuroscience', 'investigatorFullName': 'Prof. Dominique de Quervain, MD', 'investigatorAffiliation': 'University of Basel'}}}}