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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco
• Intervention / Treatment: Behavioral: Smoking Behavioral Research (IQOS); Behavioral: Smoking Behavioral Research (UBC)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Alayna P. Tackett, PhD
      • Contact: Alayna P. Tackett, PhD; Phone Number: 844-744-2447; Email: Tackett-Lab@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]); Participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their UBC ad lib over 60 minutes during laboratory visit 2.	Behavioral: Smoking Behavioral Research (IQOS); Use IQOS HeatSticks (flavor matched to the participant's usual cigarette); Behavioral: Smoking Behavioral Research (UBC); Smoke UBC
Other: Arm II (UBC, IQOS HeatSticks); 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.	Behavioral: Smoking Behavioral Research (IQOS); Use IQOS HeatSticks (flavor matched to the participant's usual cigarette); Behavioral: Smoking Behavioral Research (UBC); Smoke UBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Appeal	Participants will complete the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.	Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Product Sensory Attributes	Participants will rate sensory attributes using the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for sensory attributes such as harshness, coolness, sweetness, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater harshness, coolness, sweetness, etc.	Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Economic demand breakpoint	The price point at which a participant is no longer willing to pay for a stick of the study product will be determined by using a cigarette purchase task questionnaire.	Minute 60 of product use session
Satisfaction and psychological reward	Satisfaction and psychological reward of study product use will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using the study product on a scale from 0 (Not at all) - 6 (Extremely).	Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Abuse Liability Via Puff Topography - Total Smoking Time	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.	Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Puff Duration	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.	Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Flow Rate	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.	Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Inter-Puff Interval	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.	Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Puff Volume	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.	Minute 60 of product use session
Craving/withdrawal	Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)	Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry FEV1	Spirometry will be used to measure forced expiratory volume (FEV1)	Minute 0 before start of product use session and minute 60 of product use session
Spirometry FVC	Spirometry will be used to measure forced vital capacity (FVC)	Minute 0 before start of product use session, Minute 60 of product use session
Spirometry FEV1/FVC	Spirometry will be used to measure FEV1/FVC	Minute 0 before start of product use session, Minute 60 of product use session
Used filter count	Will assess the number of study product consumed	Minute 60 of product use session
Harm Perception	A harm perception questionnaire will be used to assess the relative and absolute perceived harm of IQOS products.	Minute 60 of product use session

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alayna P Tackett, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OSU-26080; U54CA287392 (U.S. NIH Grant/Contract); NCI-2026-04495 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY20260624 (Other Identifier: Ohio State University Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No