Caffeine Disposition After Inhalation

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Caffeine

• Registration Number: NCT02184104
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Primary Completion: 2015-11
• Study Completion: 2017-03-20
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• healthy volunteer
• non-smoker

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Energy Drink	Caffeine	A single 100 mg caffeine dose administered as an oral solution.
Aeroshot	Caffeine	A single 100 mg caffeine dose administered using the Aeroshot device.

Primary Outcome Measures

Name	Time	Method
Caffeine plasma concentration	0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours	These are the collection times of blood samples relative to when the caffeine dose was consumed.

Secondary Outcome Measures

Name	Time	Method
Caffeine effects	0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours	Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States