TobaccoNCT07688304
The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke
A study testing Smoking Behavioral Research (IQOS) and Smoking Behavioral Research (UBC) in people with Tobacco, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco
- What is being tested?
- Smoking Behavioral Research (IQOS) and Smoking Behavioral Research (UBC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Alayna P. Tackett, PhD, 844-744-2447, Tackett-Lab@osumc.edu
Alayna P. Tackett, PhD
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Tobacco
- Being tested
- Smoking Behavioral Research (IQOS), Smoking Behavioral Research (UBC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Behavioral Research (IQOS)Behavioural
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Smoking Behavioral Research (UBC)Behavioural
Smoke UBC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Smoking Behavioral Research (IQOS); Behavioral: Smoking Behavioral Research (UBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Minute 60 of product use session
Craving/withdrawal
Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)
Measured: 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
Spirometry will be used to measure forced expiratory volume (FEV1)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Minute 60 of product use session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start27 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TobaccoStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alayna Tackett, Ohio State University Comprehensive Cancer Center
- Investigators
- Alayna P Tackett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688304
- Sponsor's protocol ID
- OSU-26080
- Other IDs
- NCI-2026-04495, STUDY20260624, U54CA287392
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers
- ClinicalTrials.gov ID
- NCT07688304
- Acronym / sponsor ID
- OSU-26080
- Conditions
- Tobacco
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]) | Other | Behavioral: Smoking Behavioral Research (IQOS), Behavioral: Smoking Behavioral Research (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. |
| Arm II (UBC, IQOS HeatSticks) | Other | Behavioral: Smoking Behavioral Research (IQOS), Behavioral: Smoking Behavioral Research (UBC)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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Behavioral Research (IQOS)Use IQOS HeatSticks (flavor matched to the participant's usual cigarette) | Behavioural | Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]), Arm II (UBC, IQOS HeatSticks) |
| Smoking Behavioral Research (UBC)Smoke UBC | Behavioural | Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC]), Arm II (UBC, IQOS HeatSticks) |
Primary outcome
Product Appeal
Time frame: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
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.
Product Sensory Attributes
Time frame: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
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.
Economic demand breakpoint
Time frame: Minute 60 of product use session
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.
Satisfaction and psychological reward
Time frame: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
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).
Abuse Liability Via Puff Topography - Total Smoking Time
Time frame: Minute 60 of product use session
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.
Abuse Liability Via Puff Topography - Average Puff Duration
Time frame: Minute 60 of product use session
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.
Abuse Liability Via Puff Topography - Average Flow Rate
Time frame: Minute 60 of product use session
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.
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
Time frame: Minute 60 of product use session
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.
Abuse Liability Via Puff Topography - Average Puff Volume
Time frame: Minute 60 of product use session
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.
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
Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Alayna P Tackett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Behavioral Research (IQOS) and Smoking Behavioral Research (UBC) in people with Tobacco, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.