Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

Completed · Not applicable

Conditions studied: Cigarette Smoker, Current Smoker, Healthy Subject

In brief

This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.

Key facts

Study ID

NCT02575885

Run by

Roswell Park Cancer Institute

People needed

36

Starts

2016-03-16

Expected to finish

2018-06-06

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy on the basis of medical history
• Current moderate-to-heavy smoker as determined by:
• Has smoked >=10 cigarettes per day regularly for the past year (by history) and (>=5 cigarettes per day Study 2 ONLY)
• Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY)
• Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence
• Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits
• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if…

• Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
• Pregnancy or lactation (by history) or positive pregnancy test at screening visit
• Positive urine drug test at screening visit
• History of serious side effects from nicotine or from any nicotine replacement therapies
• Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
• Concurrent participation in another clinical trial
• Unable to communicate in English
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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