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Clinical Trial Summary

A novel heat-not-burn tobacco product (IQOS) will be provided to smokers screened for lung cancer risk, 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.

Clinical Trial Description

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 screened for lung cancer. 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 Design

Related Conditions & MeSH terms

NCT number NCT04861428
Study type Interventional
Source University of Pittsburgh
Status Not yet recruiting
Phase N/A
Start date May 2021
Completion date April 2022

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