The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke

Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers

This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.

PRIMARY OBJECTIVES:

I. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.

SECONDARY OBJECTIVES:

I. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.

II. Evaluate the effect of perceived harm on IQOS use behavior.

EXPLORATORY OBJECTIVE:

I. Examine acute changes to pulmonary health associated with IQOS use.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use IQOS HeatSticks (flavor matched to their usual cigarette) as much as desired (ad lib) over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their usual brand cigarette (UBC) ad lib over 60 minutes during laboratory visit 2.

ARM II: Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.

Inclusion Criteria:

• Adults 21-65 years
• Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)
• Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit
• Willing to bring UBC to each study visit
• Read, write and speak English

Exclusion Criteria:

• Current use of other non-combustible nicotine products (e.g., electronic [e]-cigarettes, HTPs; [defined as ≥ 5 days weekly use in the past 30 days])
• Planning to quit nicotine use and/or use of any smoking cessation medication in the past 30 days
• Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)
• Self-reported unstable or significant psychiatric conditions (past/stable conditions will be allowed)
• History of cardiac event or distress within the past 3 months
• Deaf, hard of hearing, or have a severe motor disability
• Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)