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

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03822546

Run by

Fontem Ventures BV

People needed

15

Starts

2018-04-01

Expected to finish

2018-04-30

Last updated by the study team

2019-01-30

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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