Recruiting

HTPs

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07688304

Conditions

Tobacco

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Smoking Behavioral Research (IQOS)

Smoking Behavioral Research (UBC)

Study Details

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

Study ID

NCT07688304

Start date

Aug 27, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Smoking Behavioral Research (IQOS)

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

Smoking Behavioral Research (UBC)

Smoke UBC

Primary outcome measure

  • Product Appeal [ Time Frame: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session ]
  • Product Sensory Attributes [ Time Frame: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session ]
  • Economic demand breakpoint [ Time Frame: Minute 60 of product use session ]
  • Satisfaction and psychological reward [ Time Frame: 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 [ Time Frame: Minute 60 of product use session ]
  • Abuse Liability Via Puff Topography - Average Puff Duration [ Time Frame: Minute 60 of product use session ]
  • Abuse Liability Via Puff Topography - Average Flow Rate [ Time Frame: Minute 60 of product use session ]
  • Abuse Liability Via Puff Topography - Average Inter-Puff Interval [ Time Frame: Minute 60 of product use session ]
  • Abuse Liability Via Puff Topography - Average Puff Volume [ Time Frame: Minute 60 of product use session ]
  • Craving/withdrawal [ Time Frame: Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Alayna P. Tackett, PhD

844-744-2447Tackett-Lab@osumc.edu

Principal Investigator:

Alayna P. Tackett, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-31.