Caffeine Disposition After Inhalation
Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device
2 other identifiers
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2014
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2017
CompletedOctober 26, 2017
October 1, 2017
1.3 years
July 2, 2014
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caffeine plasma concentration
These are the collection times of blood samples relative to when the caffeine dose was consumed.
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours
Secondary Outcomes (1)
Caffeine effects
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Other Outcomes (1)
Cardiovascular effects
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Study Arms (2)
Aeroshot
ACTIVE COMPARATORA single 100 mg caffeine dose administered using the Aeroshot device.
Energy Drink
ACTIVE COMPARATORA single 100 mg caffeine dose administered as an oral solution.
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteer
- non-smoker
You may not qualify if:
- Take chronic medication
- Co-existing diseases
- Platelet count less than 100,000/uL (per microliter)
- Acute or chronic psychiatric condition
- Consume more than 300 mg of caffeine per day
- Participated in another study within last 30 days or donated blood in last 6 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tennesseelead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven C. Laizure, Pharm.D.
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 9, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2015
Study Completion
March 20, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share