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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02184104
Enrollment
24
Registered
2014-07-09
Start date
2014-07-31
Completion date
2017-03-20
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

caffeine, pharmacokinetics, pharmacodynamics

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.

Interventions

DIETARY_SUPPLEMENTCaffeine

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Tennessee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Caffeine plasma concentration0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hoursThese are the collection times of blood samples relative to when the caffeine dose was consumed.

Secondary

MeasureTime frameDescription
Caffeine effects0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hoursSubjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.

Other

MeasureTime frameDescription
Cardiovascular effects0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hoursThe heart rate and blood pressure will be recorded at the time of each blood collection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026