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Not yet recruiting NCT07688304

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

No phase Interventional Tobacco

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking Behavioral Research (IQOS), Smoking Behavioral Research (UBC).
Who it may be relevant to
Registry conditions: Tobacco. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Behavioral Smoking Behavioral Research (IQOS)
    Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
  • Behavioral Smoking Behavioral Research (UBC)
    Smoke UBC

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Spirometry FEV1 [Time frame: Minute 0 before start of product use session and minute 60 of product use session]
  • Spirometry FVC [Time frame: Minute 0 before start of product use session, Minute 60 of product use session]
  • Spirometry FEV1/FVC [Time frame: Minute 0 before start of product use session, Minute 60 of product use session]
  • Used filter count [Time frame: Minute 60 of product use session]
  • Harm Perception [Time frame: Minute 60 of product use session]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07688304 · OSU-26080 · NCI-2026-04495 · STUDY20260624 · U54CA287392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗