Caffeine Disposition After Inhalation

October 24, 2017 updated by: University of Tennessee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Steven C. Laizure, Pharm.D., University of Tennessee Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 20, 2017

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-02648-FB
  • 1R03DA035347-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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