Vaporized Nicotine and Autonomic Control

Study Overview
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Brief Summary
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E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).

Official Title
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Vaporized Nicotine and Autonomic Control

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Device: Electronic Cigarette containing nicotine
* Device: Electronic Cigarette without nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusion Criteria: Individuals with a history of hyperthyroidism Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant Individuals currently taking prescription drugs. Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.) Individuals with hypertension (systolic >130 and/or diastolic > 80). Individuals with a history of tobacco or vaporized nicotine use. Individuals who have been diagnosed with diabetes Individuals who are under the age of 18 or over the age of 40

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Repeated Measures
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>E-cigarette containing no nicotine. | Device: Electronic Cigarette without nicotine<br>* Non-smokers used an electronic cigarette without nicotine<br>* Other names: Smok (brand name);|
| Active Comparator: Nicotine<br>E-cigarette containing nicotine | Device: Electronic Cigarette containing nicotine<br>* Non-smokers used an electronic cigarette containing nicotine<br>* Other names: JUUL (brand name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (measured from the finger) | Effects of electronic cigarettes on both systolic and diastolic arterial pressure. | Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged. | 
| Muscle sympathetic nerve activity (measured with the microneurography technique) | Effects of electronic cigarettes on muscle sympathetic nerve activity (MSNA) | Experiments were separated by one month. MSNA was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-cigarette, Autonomic Control, Muscle Sympathetic Nerve Activity