Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 3:37 PM
Study NCT ID:
NCT02184104
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2014-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine Disposition After Inhalation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-07-08', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular effects', 'timeFrame': '0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours', 'description': 'The heart rate and blood pressure will be recorded at the time of each blood collection.'}], 'primaryOutcomes': [{'measure': 'Caffeine plasma concentration', 'timeFrame': '0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours', 'description': 'These are the collection times of blood samples relative to when the caffeine dose was consumed.'}], 'secondaryOutcomes': [{'measure': 'Caffeine effects', 'timeFrame': '0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours', 'description': 'Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caffeine', 'pharmacokinetics', 'pharmacodynamics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how fast caffeine gets into your body with a product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your blood. You will also be asked to fill out some scales to measure the effects you feel after the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster than after an energy drink.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer\n* non-smoker\n\nExclusion Criteria:\n\n* Take chronic medication\n* Co-existing diseases\n* Platelet count less than 100,000/uL (per microliter)\n* Acute or chronic psychiatric condition\n* Consume more than 300 mg of caffeine per day\n* Participated in another study within last 30 days or donated blood in last 6 weeks'}, 'identificationModule': {'nctId': 'NCT02184104', 'briefTitle': 'Caffeine Disposition After Inhalation', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device', 'orgStudyIdInfo': {'id': '13-02648-FB'}, 'secondaryIdInfos': [{'id': '1R03DA035347-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R03DA035347-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aeroshot', 'description': 'A single 100 mg caffeine dose administered using the Aeroshot device.', 'interventionNames': ['Dietary Supplement: Caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Energy Drink', 'description': 'A single 100 mg caffeine dose administered as an oral solution.', 'interventionNames': ['Dietary Supplement: Caffeine']}], 'interventions': [{'name': 'Caffeine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Aeroshot', 'Energy Drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Steven C. Laizure, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}