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Caffeine Disposition After Inhalation

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring caffeine, pharmacokinetics, pharmacodynamics

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aeroshot

Energy Drink

Arm Description

A single 100 mg caffeine dose administered using the Aeroshot device.

A single 100 mg caffeine dose administered as an oral solution.

Outcomes

Primary Outcome Measures

Caffeine plasma concentration
These are the collection times of blood samples relative to when the caffeine dose was consumed.

Secondary Outcome Measures

Caffeine effects
Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.

Full Information

First Posted
July 2, 2014
Last Updated
October 24, 2017
Sponsor
University of Tennessee
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02184104
Brief Title
Caffeine Disposition After Inhalation
Official Title
Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
caffeine, pharmacokinetics, pharmacodynamics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aeroshot
Arm Type
Active Comparator
Arm Description
A single 100 mg caffeine dose administered using the Aeroshot device.
Arm Title
Energy Drink
Arm Type
Active Comparator
Arm Description
A single 100 mg caffeine dose administered as an oral solution.
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine
Primary Outcome Measure Information:
Title
Caffeine plasma concentration
Description
These are the collection times of blood samples relative to when the caffeine dose was consumed.
Time Frame
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours
Secondary Outcome Measure Information:
Title
Caffeine effects
Description
Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.
Time Frame
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Other Pre-specified Outcome Measures:
Title
Cardiovascular effects
Description
The heart rate and blood pressure will be recorded at the time of each blood collection.
Time Frame
0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C. Laizure, Pharm.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Caffeine Disposition After Inhalation

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