A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.
The current within-subjects crossover study aims to directly compare initial efficacy of IQOS vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers. Study interventions include IQOS, a commercially available, over the counter product. The IQOS is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade. All procedures will take place in the Prevention and Early Detection Center (PEDC) at the UPMC Hillman Cancer Center. Participants will be assessed daily via remote CO assessment and online questionnaire throughout the entire study (WK1-WK5). At the end of a one-week baseline of normal smoking (WK1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive IQOS use (IQOS First); or 2) continue to smoke as usual (IQOS Last; WK2-WK3), followed by a second two-week period during which they will smoke as usual or attempt to switch to IQOS (opposite of the first period; WK4-WK5).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
4
IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
Cigarette smoking
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Objective smoke exposure
Assessed daily using a mobile carbon monoxide monitor (iCO) provided to participants. Carbon monoxide (CO) readings parts per million (ppm) will be submitted directly via email using the iCO smartphone app.
Time frame: Up to 5 weeks
Self-reported smoke exposure
Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.
Time frame: Up to 5 weeks
Harm exposure - Lung function
Lung function will be assessed using standard pulmonary function test.
Time frame: Up to 5 weeks
Harm exposure - Blood pressure
Blood pressure will be assessed using a sphygmomanometer.
Time frame: Up to 5 weeks
Cigarette craving
Cigarette craving measured daily via Qualtrics using the Questionnaire of Smoking Urges Brief version. This will be measured on a 0-100 visual analog scale. Higher scored indicate greater craving.
Time frame: Up to 5 weeks
Withdrawal symptoms
Withdrawal symptoms measured daily via Qualtrics using the Minnesota Nicotine Withdrawal Scale. This will be measured on a 0-18 scale. Higher scores indicate greater withdrawal symptoms.
Time frame: Up to 5 weeks
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