Vaporized Nicotine and Autonomic Control

NCT04613609 | Completed Early Phase 1

• 1 other identifier: M1747
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Electronic Cigarette Use

Keywords

E-cigarette; Autonomic Control; Muscle Sympathetic Nerve Activity

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

E-cigarette containing no nicotine.

Device: Electronic Cigarette without nicotine

Nicotine

ACTIVE COMPARATOR

E-cigarette containing nicotine

Device: Electronic Cigarette containing nicotine

Interventions

Electronic Cigarette containing nicotine DEVICE

Non-smokers used an electronic cigarette containing nicotine

Also known as: JUUL (brand name)

Nicotine

Electronic Cigarette without nicotine DEVICE

Non-smokers used an electronic cigarette without nicotine

Also known as: Smok (brand name)

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan Technological University: lead

Study Sites (1)

Michigan Technological University

Houghton, Michigan, 49930, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed if they were to receive nicotine or placebo
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated Measures

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 3, 2020
• Study Start: April 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

US (1)