Vaporized Nicotine and Autonomic Control

Electronic Cigarette Use Clinical Trial

Official title:

Vaporized Nicotine and Autonomic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613609
• Other study ID #: M1747
• Status: Completed
• Phase: Early Phase 1
• Start date: April 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2020
• Source: Michigan Technological University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

Device:
• Electronic Cigarette containing nicotine
Non-smokers used an electronic cigarette containing nicotine
• Electronic Cigarette without nicotine
Non-smokers used an electronic cigarette without nicotine

Locations

Country	Name	City	State
United States	Michigan Technological University	Houghton	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan Technological University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.