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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-04495 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY20260624 | Other Identifier | Ohio State University Comprehensive Cancer Center | |
| U54CA287392 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking Behavioral Research (IQOS) | Behavioral | Use IQOS HeatSticks (flavor matched to the participant's usual cigarette) |
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| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alayna P Tackett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Smoking Behavioral Research (UBC) | Behavioral | Smoke UBC |
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| 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 |
| 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 |