Vaporized Nicotine and Autonomic Control

Early Phase 1

Completed

• Conditions: Electronic Cigarette Use
• Interventions: Device: Electronic Cigarette containing nicotine; Device: Electronic Cigarette without nicotine

• Registration Number: NCT04613609
• Lead Sponsor: Michigan Technological University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine	Electronic Cigarette containing nicotine	E-cigarette containing nicotine
Placebo	Electronic Cigarette without nicotine	E-cigarette containing no nicotine.

Primary Outcome Measures

Name	Time	Method
Blood pressure (measured from the finger)	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.
Muscle sympathetic nerve activity (measured with the microneurography technique)	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)

Trial Locations

Locations (1)

Michigan Technological University; 🇺🇸 Houghton, Michigan, United States