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OpenTrials
Completed

NCT Number: NCT02184104

Caffeine Disposition After Inhalation

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.

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Key information

Conditions

Healthy

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Dietary Supplement

Primary outcomes

  1. Caffeine plasma concentration

    Time frame: 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 outcomes

  1. Caffeine effects

    Time frame: 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.

Other outcomes

  1. Cardiovascular effects

    Time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours

    The heart rate and blood pressure will be recorded at the time of each blood collection.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 9, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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