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

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)