Caffeine Disposition After Inhalation

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Caffeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aeroshot<br>A single 100 mg caffeine dose administered using the Aeroshot device. | Dietary Supplement: Caffeine<br> <br> |
| Active Comparator: Energy Drink<br>A single 100 mg caffeine dose administered as an oral solution. | Dietary Supplement: Caffeine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacodynamics, caffeine, pharmacokinetics