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Healthy VolunteersEarly Phase 1CALMNCT02135965

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate

A Early Phase 1 study testing 2mg of Albuterol, 4mg of Albuterol and 100mg of Caffeine in people with Healthy Volunteers, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
2mg of Albuterol, 4mg of Albuterol and 100mg of Caffeine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Apr 2009to Aug 2011
Phase
Early Phase 1
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female between the ages of 18 to 50 years, inclusive.
  • Have a body mass index between 19 and 40 kg/M2 ( a number calculated from your height and weight), inclusive.

Who cannot join

  • Female who is pregnant or nursing.
  • Woman of childbearing potential and do not agree to use an effective method of contraception during the trial. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.
  • A smoker or use nicotine.
  • Take regular medication other than birth control pills.
  • Use medications known to alter metabolic rate (some asthma medications).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.

The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.

Read the detailed description

The study consists of 2 screening visits and 8 study visits. Screening visit 1: about 1 hour fasting from 9pm the prior night. Height and weight is measured, vital signs taken and questionnaires completed. Women will have a urine pregnancy test. Blood draw for chemistry panel and blood count.

Screening visit 2: about 1 hour, Medical history, physical examination, and electrocardiogram (a heart tracing).

Visit 1-8 about 4 hours each. 8 separate occasions, with about 7 days between each visit. ON each visit, blood pressure, pulse and temperature is recorded. A resting metabolic rate (RMR) is measured. After a baseline measurement of about 30 minutes of breathing is taken , a pill will be swallow and metabolism(measured by breathing with a clear plastic hood over the upper body to measure metabolic rate ( the oxygen inhaled and the carbon dioxide exhaled).

Being tested
2mg of Albuterol, 4mg of Albuterol, 100mg of Caffeine, 200mg of Caffeine, Albuterol 2mg & Caffeine 100mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2mg of AlbuterolDrug

    Also called Albuterol

    2mg of Albuterol on metabolic rate

  • 4mg of AlbuterolDrug

    Also called Albuterol

    4mg of Albuterol on metabolic rate

  • 100mg of CaffeineDrug

    Also called Caffeine

    100mg of caffeine on metabolic rate

  • 200mg of CaffeineDrug

    Also called Caffeine

    200mg of Caffeine on metabolic rate

  • Albuterol 2mg & Caffeine 100mgDrug

    Also called Caffeine, Albuterol

    Albuterol 2mg and 100mg of Caffeine

  • Albuterol 2mg and Caffeine 200mgDrug

    Also called Albuterol, Caffeine

    Albuterol 2mg and Caffeine 200mg on metabolic rate

  • Albuterol 4mg and Caffeine 100mgDrug

    Also called Albuterol, Caffeine

    Albuterol 4mg and Caffeine 100mg on metabolic rate

  • Albuterol 4mg and Caffeine 200mgDrug

    Also called Albuterol, Caffeine

    Albuterol 4mg and Caffeine 200mg on metabolic rate

Study groups in NCT02135965
Study groupRoleWhat they receive
Albuterol 2mgExperimental2 mg of Albuterol is in a pill form or placebo
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mgExperimental4mg of Albuterol or placebo is given in pill form
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Caffeine 100mgExperimental100mg of Caffeine or placebo is given in a pill form.
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Caffeine 200mgExperimental200mg of Caffeine or placebo is given in a pill form
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 2mg & Caffeine 100mgExperimental100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Receives: Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mgExperimental200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 100mgExperimental100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mgExperimental200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Receives: Drug: 2mg of Albuterol; Drug: 4mg of Albuterol; Drug: 100mg of Caffeine; Drug: 200mg of Caffeine; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.

    The order of which 8 combinations will be determined randomly (like flipping a coin) and neither the participant nor the study personnel will know what is in the pills. The identity of the pills can be determined by breaking the code in the case of an emergency. 1. Albuterol 2mg; 2. Albuterol 4mg; 3. Caffeine 100mg; 4. Caffeine 200mg; 5. Albuterol 2mg and Caffeine 100mg; 6. Albuterol 2mg and Caffeine 200mg; 7. Albuterol 4mg and Caffeine 100mg; 8. Albuterol 4mg and Caffeine 200mg. The data will be analyzed by computing the metabolic rate. Metabolic rate is measured by breathing with a clear plastic hood over the upper body to measure the oxygen inhaled and the carbon dioxide exhaled.

    Measured: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.

Secondary outcomes (5)

  1. Respiratory Quotient (RQ)

    The respiratory quotient (RQ) is calculated from a ratio indicating the relation of the volume of carbon dioxide given off in respiration to that of the oxygen consumed.

    Measured: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.

  2. Pulse rate

    Pulse is the rate at which the heart beats. The pulse is usually called heart rate, which is the number of times the heart beats each minute.

    Measured: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.

  3. Blood Pressure

    When the heart beats, it contracts and pushes blood through the arteries to the rest of your body. This force creates pressure on the arteries. This is called systolic blood pressure or the top number. A systolic blood pressure or the bottom number indicates the pressure in the arteries when the heart rests between beats.

    Measured: Baseline to 8 time points of dose

  4. Temperature

    An oral temperature is when the thermometer is placed in the mouth to measure the body heat.

    Measured: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.

  5. Safety Assessments (lab, adverse events, physical exams and electrocardiograms)

    Labs, adverse events, physical exams and electrocardiograms (ECG or EKG) are assessed to make sure nothing is out of normal range.

    Measured: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2014 (estimated)
  2. Study startApr 2009
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135965
Sponsor's protocol ID
PBRC 28026
Acronym
CALM
Status last verified
Dec 2015
First submitted
7 May 2014
Last updated
18 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 2mg of Albuterol, 4mg of Albuterol and 100mg of Caffeine in people with Healthy Volunteers, run by Pennington Biomedical Research Center 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 5 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 18 Dec 2015. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate. (time frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02135965.

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 18 Dec 2015.

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