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

NCT07688304 | Not Yet Recruiting

• 4 other identifiers: OSU-26080NCI-2026-04495STUDY20260624U54CA287392
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Spirometry FEV1

  Minute 0 before start of product use session and minute 60 of product use session

• Spirometry FVC

  Minute 0 before start of product use session, Minute 60 of product use session

• Spirometry FEV1/FVC

  Minute 0 before start of product use session, Minute 60 of product use session

• Used filter count

  Minute 60 of product use session

• Harm Perception

  Minute 60 of product use session

Study Arms (2)

Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])

OTHER

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); Behavioral: Smoking Behavioral Research (UBC)

Arm II (UBC, IQOS HeatSticks)

OTHER

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); Behavioral: Smoking Behavioral Research (UBC)

Interventions

Smoking Behavioral Research (IQOS) BEHAVIORAL

Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)

Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]); Arm II (UBC, IQOS HeatSticks)

Smoking Behavioral Research (UBC) BEHAVIORAL

Smoke UBC

Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]); Arm II (UBC, IQOS HeatSticks)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Study Officials

• Alayna P Tackett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)