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Completed

NCT Number: NCT03822546

A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations

This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.

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Key information

Conditions

Healthy Volunteers

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Having smoked ≥10 manufactured cigarettes per day for at least the last year
  • Expired carbon monoxide level of >10 ppm at screening
  • Tested positive for urinary cotinine (≥500 ng/mL)

Exclusion criteria

  • Known or suspected hypersensitivity to any component of the e-liquid formulations
  • Taking or receiving prescription smoking cessation medicines
  • Willing or considering to stop smoking
  • Smokers who draw smoke into their mouth and throat but do not inhale
  • Relevant illness history
  • Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
  • Breastfeeding women
  • Women of child-bearing potential who were not using an accepted method of contraception

Treatment and study plan

Conventional cigarette

Other

Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals

myblu 25 mg freebase

Other

E-cigarette used for 10 inhalations every 30 seconds

myblu 16 mg nicotine salt

Other

E-cigarette used for 10 inhalations every 30 seconds

myblu 25 mg nicotine salt

Other

E-cigarette used for 10 inhalations every 30 seconds

myblu 40 mg nicotine salt

Other

E-cigarette used for 10 inhalations every 30 seconds

blu PRO 48 mg nicotine salt

Other

E-cigarette used for 10 inhalations every 30 seconds

Primary outcomes

  1. Nicotine pharmacokinetics Cmax

    Time frame: 30 minutes following the start of product use (12 measurements over the period)

    Mean maximum plasma nicotine concentration (Cmax)

  2. Nicotine pharmacokinetics Tmax

    Time frame: 30 minutes following the start of product use (12 measurements over the period)

    Median time to maximum plasma nicotine concentration (Tmax)

  3. Nicotine pharmacokinetics AUC0-30

    Time frame: 30 minutes following the start of product use (12 measurements over the period)

    Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)

Secondary outcomes

  1. Subjective effects questionnaire

    Time frame: 20 minutes after the start of product use

    Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine?

  2. Incidence and nature of any adverse events (AE)

    Time frame: Through study completion, 6 days

    Incidence and nature of any adverse events (AE) (Safety and Tolerability)

Sponsors and collaborators

Lead sponsor

Fontem Ventures BV

Industry

Registry information

Official study title

A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

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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