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

Pennington Biomedical Research Center

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 4mg of Albuterol; Drug: Albuterol 2mg & Caffeine 100mg; Drug: Albuterol 4mg and Caffeine 200mg; Drug: Albuterol 2mg and Caffeine 200mg; Drug: Albuterol 4mg and Caffeine 100mg; Drug: 100mg of Caffeine; Drug: 2mg of Albuterol; Drug: 200mg of Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT02135965

PBRC 28026

Details and patient eligibility

About

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

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 8 patient groups

Albuterol 2mg

Experimental group

Description:

2 mg of Albuterol is in a pill form or placebo

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Albuterol 4mg

Experimental group

Description:

4mg of Albuterol or placebo is given in pill form

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Caffeine 100mg

Experimental group

Description:

100mg of Caffeine or placebo is given in a pill form.

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Caffeine 200mg

Experimental group

Description:

200mg of Caffeine or placebo is given in a pill form

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Albuterol 2mg & Caffeine 100mg

Experimental group

Description:

100mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.

Treatment:

Drug: 200mg of Caffeine

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Albuterol 2mg and Caffeine 200mg

Experimental group

Description:

200mg of Caffeine in combination with Albuterol 2mg or placebo is given in a pill form.

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Albuterol 4mg and Caffeine 100mg

Experimental group

Description:

100mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol

Albuterol 4mg and Caffeine 200mg

Experimental group

Description:

200mg of Caffeine in combination with Albuterol 4mg or placebo is given in a pill form.

Treatment:

Drug: 200mg of Caffeine

Drug: 2mg of Albuterol

Drug: 100mg of Caffeine

Drug: Albuterol 4mg and Caffeine 100mg

Drug: Albuterol 2mg and Caffeine 200mg

Drug: Albuterol 4mg and Caffeine 200mg

Drug: Albuterol 2mg & Caffeine 100mg

Drug: 4mg of Albuterol