Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers

Conditions
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Smoking Behaviors

Intervention / Treatment
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* Other: IQOS
* Other: Smoking as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ages 21-77 Current smoker with ≥5 cigarettes per day for ≥1 year history of smoking Screening CO ≥8 ppm Not currently interested in quitting smoking Willing to briefly switch from combustible to noncombustible nicotine Have reliable daily access to a smartphone or tablet compatible with the iCO Smokerlyzer app: Android 8 or higher, iOS 8 or higher Bluetooth-enabled device Exclusion Criteria: Current use of smoking cessation medications such as varenicline or bupropion Major chronic medical problems, including cardiovascular disease, diabetes Pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQOS / Smoking as usual<br>Two weeks of IQOS, followed by two weeks of cigarette smoking as usual. | Other: IQOS<br>* IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).<br>Other: Smoking as Usual<br>* Cigarette smoking<br>|
| Active Comparator: Smoking as usual / IQOS<br>Two weeks of cigarette smoking as usual, followed by two weeks of IQOS. | Other: IQOS<br>* IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).<br>Other: Smoking as Usual<br>* Cigarette smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 weeks | 
| Self-reported smoke exposure | Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey. | Up to 5 weeks | 
| Harm exposure - Lung function | Lung function will be assessed using standard pulmonary function test. | Up to 5 weeks | 
| Harm exposure - Blood pressure | Blood pressure will be assessed using a sphygmomanometer. | Up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HnB: heat not burn tobacco product, IQOS: commercially available HnB manufactured