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OpenTrials
Completed

NCT Number: NCT04613609

Vaporized Nicotine and Autonomic Control

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).

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Michigan Technological University

Houghton, Michigan, 49930, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Cigarette containing nicotine

Device

Non-smokers used an electronic cigarette containing nicotine

Other names: JUUL (brand name)

Electronic Cigarette without nicotine

Device

Non-smokers used an electronic cigarette without nicotine

Other names: Smok (brand name)

Primary outcomes

  1. Blood pressure (measured from the finger)

    Time frame: 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.

    Effects of electronic cigarettes on both systolic and diastolic arterial pressure.

  2. Muscle sympathetic nerve activity (measured with the microneurography technique)

    Time frame: 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.

    Effects of electronic cigarettes on muscle sympathetic nerve activity (MSNA)

Sponsors and collaborators

Lead sponsor

Michigan Technological University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2020
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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