The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke
ConditionTobacco
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorOhio State University Comprehensive Cancer Center
About this trial
This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Smoking Behavioral Research (IQOS)
BehavioralUse IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Smoking Behavioral Research (UBC)
BehavioralSmoke UBC
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])Other 2 interventions
Group B: Arm II (UBC, IQOS HeatSticks)Other 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session2
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.
Time frame
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session3
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.
Time frame
Minute 60 of product use session4
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).
Time frame
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use sessionSecondary outcomes
1
Spirometry FEV1
Spirometry will be used to measure forced expiratory volume (FEV1)
Time frame
Minute 0 before start of product use session and minute 60 of product use session2
Spirometry FVC
Spirometry will be used to measure forced vital capacity (FVC)
Time frame
Minute 0 before start of product use session, Minute 60 of product use session3
Spirometry FEV1/FVC
Spirometry will be used to measure FEV1/FVC
Time frame
Minute 0 before start of product use session, Minute 60 of product use session4
Used filter count
Will assess the number of study product consumed
Time frame
Minute 60 of product use sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov