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Vaporized Nicotine and Autonomic Control

M

Michigan Technological University

Status and phase

Completed
Early Phase 1

Conditions

Electronic Cigarette Use

Treatments

Device: Electronic Cigarette containing nicotine
Device: Electronic Cigarette without nicotine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

16 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
E-cigarette containing no nicotine.
Treatment:
Device: Electronic Cigarette without nicotine
Nicotine
Active Comparator group
Description:
E-cigarette containing nicotine
Treatment:
Device: Electronic Cigarette containing nicotine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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