HealthyNCT02184104
Caffeine Disposition After Inhalation
A study testing Caffeine in people with Healthy, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
- non-smoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Caffeine
- Keywords
- caffeine, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Aeroshot | Active comparator | A single 100 mg caffeine dose administered using the Aeroshot device. Receives: Dietary Supplement: Caffeine |
| Energy Drink | Active comparator | A single 100 mg caffeine dose administered as an oral solution. Receives: Dietary Supplement: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caffeine plasma concentration
These are the collection times of blood samples relative to when the caffeine dose was consumed.
Measured: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours
Secondary outcomes (1)
Caffeine effects
Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.
Measured: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Steven C. Laizure, Pharm.D., Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184104
- Sponsor's protocol ID
- 13-02648-FB
- Other IDs
- 1R03DA035347-01A1
- Status last verified
- Oct 2017
- First submitted
- 2 Jul 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02184104
- Acronym / sponsor ID
- 13-02648-FB
- Conditions
- Healthy
- Keywords
- caffeine, pharmacokinetics, pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aeroshot | Active comparator | Dietary Supplement: CaffeineA single 100 mg caffeine dose administered using the Aeroshot device. |
| Energy Drink | Active comparator | Dietary Supplement: CaffeineA single 100 mg caffeine dose administered as an oral solution. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteer
- non-smoker
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine | Dietary supplement | Aeroshot, Energy Drink |
Primary outcome
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.
1 secondary outcome
Caffeine effects
Time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C. Laizure, Pharm.D. principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Healthy, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caffeine plasma concentration (time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.