Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
CALM
1 other identifier
interventional
8
1 country
1
Brief Summary
The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 healthy-volunteers
Started Apr 2009
Longer than P75 for early_phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedDecember 18, 2015
December 1, 2015
2.3 years
May 7, 2014
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (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.
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Secondary Outcomes (5)
Respiratory Quotient (RQ)
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Pulse rate
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Blood Pressure
Baseline to 8 time points of dose
Temperature
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Safety Assessments (lab, adverse events, physical exams and electrocardiograms)
Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.
Study Arms (8)
Albuterol 2mg
EXPERIMENTAL2 mg of Albuterol is in a pill form or placebo
Albuterol 4mg
EXPERIMENTAL4mg of Albuterol or placebo is given in pill form
Caffeine 100mg
EXPERIMENTAL100mg of Caffeine or placebo is given in a pill form.
Caffeine 200mg
EXPERIMENTAL200mg of Caffeine or placebo is given in a pill form
Albuterol 2mg & Caffeine 100mg
EXPERIMENTAL100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Albuterol 2mg and Caffeine 200mg
EXPERIMENTAL200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.
Albuterol 4mg and Caffeine 100mg
EXPERIMENTAL100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Albuterol 4mg and Caffeine 200mg
EXPERIMENTAL200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.
Interventions
2mg of Albuterol on metabolic rate
4mg of Albuterol on metabolic rate
100mg of caffeine on metabolic rate
200mg of Caffeine on metabolic rate
Albuterol 2mg and 100mg of Caffeine
Albuterol 2mg and Caffeine 200mg on metabolic rate
Albuterol 4mg and Caffeine 100mg on metabolic rate
Albuterol 4mg and Caffeine 200mg on metabolic rate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 12, 2014
Study Start
April 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 18, 2015
Record last verified: 2015-12