This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.
This study proposes to assess the relative role of nicotine dose and route of delivery in affecting successful switching from combustible cigarettes to e-cigarettes, as well as concomitant reductions in ad libitum cigarette smoking and exposure to harmful and potentially harmful constituents of combustion. The strategy will be to assess adoption of e-cigarette use and concomitant reduction in ad libitum smoking of subjects' usual brands of cigarettes over an 8-week period, during which they will receive nicotine or non-nicotine e-cigarettes, and nicotine skin patches. The nicotine patches will not be used as a therapeutic treatment in this study, but rather as a way to manipulate the nicotine dose, while varying the rate and route of nicotine delivery. Behavioral or "habit" aspects of e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes. Initially the study design included placebo patch control conditions, but due to limitations in budget and period of support, enrollment in these these arms was discontinued. All participants currently receive active nicotine patches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
94
Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Expired Air Carbon Monoxide (CO) to Assess Recent Smoking
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).
Time frame: Week 8
Cigarette Use, Assessed by Self-report in Daily Dairies
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on self-report of cigarette consumption on daily diaries (for week 8 only, average cigarettes smoked per day).
Time frame: Week 8
E-cigarette Use, Assessed by Self-report in Daily Dairies
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of e-cigarettes will be assessed by comparing the groups on self-report of e-cigarette use on daily diaries (for week 8 only).
Time frame: Week 8
Total Urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on total urinary NNAL, a metabolite of the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), at the end of week 8.
Time frame: Week 8
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Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.