IQOS (Non-Cigarette Tobacco Product) Pilot Study

Study Overview
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Brief Summary
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A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

Official Title
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Impact Of IQOS Non-Cigarette Tobacco Product On Reinforcement Value and Use In Current Smokers

Conditions
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Smoking, Tobacco Use

Intervention / Treatment
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* Behavioral: IQOS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: daily cigarette smoker interested in using non-cigarette tobacco product have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion). Exclusion Criteria: additional tobacco use criteria additional medical criteria

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQOS group<br> | Behavioral: IQOS<br>* Participants will try an IQOS product and then take home the IQOS to sample for one week.<br>* Other names: heated tobacco product (HTP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Prefer IQOS | Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette | Lab Visit 2, occurring approximately one week after the initial screening/baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes Per Day | The average percent reduction in cigarettes per day observed in Week 2 | Week 2 of study |