Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 858 for:    ALBUTEROL

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate (CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135965
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers 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 Early Phase 1

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.
Study Start Date : April 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Albuterol 2mg
2 mg of Albuterol is in a pill form or placebo
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Albuterol 4mg
4mg of Albuterol or placebo is given in pill form
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Caffeine 100mg
100mg of Caffeine or placebo is given in a pill form.
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Caffeine 200mg
200mg of Caffeine or placebo is given in a pill form
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Albuterol 2mg & Caffeine 100mg
100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Albuterol 2mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Albuterol 4mg and Caffeine 100mg
100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Experimental: Albuterol 4mg and Caffeine 200mg
200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Drug: 2mg of Albuterol
2mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 4mg of Albuterol
4mg of Albuterol on metabolic rate
Other Name: Albuterol

Drug: 100mg of Caffeine
100mg of caffeine on metabolic rate
Other Name: Caffeine

Drug: 200mg of Caffeine
200mg of Caffeine on metabolic rate
Other Name: Caffeine

Drug: Albuterol 2mg & Caffeine 100mg
Albuterol 2mg and 100mg of Caffeine
Other Names:
  • Caffeine
  • Albuterol

Drug: Albuterol 2mg and Caffeine 200mg
Albuterol 2mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 100mg
Albuterol 4mg and Caffeine 100mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine

Drug: Albuterol 4mg and Caffeine 200mg
Albuterol 4mg and Caffeine 200mg on metabolic rate
Other Names:
  • Albuterol
  • Caffeine




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. Respiratory Quotient (RQ) [ Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks. ]
    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.

  2. Pulse rate [ Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks. ]
    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.

  3. Blood Pressure [ Time Frame: Baseline to 8 time points of dose ]
    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.

  4. Temperature [ Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks. ]
    An oral temperature is when the thermometer is placed in the mouth to measure the body heat.

  5. Safety Assessments (lab, adverse events, physical exams and electrocardiograms) [ Time Frame: Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks. ]
    Labs, adverse events, physical exams and electrocardiograms (ECG or EKG) are assessed to make sure nothing is out of normal range.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135965


Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center

Layout table for additonal information
Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02135965     History of Changes
Other Study ID Numbers: PBRC 28026
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Albuterol
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents