Tobacco
Conditions
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.
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
BEHAVIORALSmoking Behavioral Research (IQOS)
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
BEHAVIORALSmoking Behavioral Research (UBC)
Smoke UBC
Sponsors
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Appeal | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirometry FEV1 | Minute 0 before start of product use session and minute 60 of product use session | Spirometry will be used to measure forced expiratory volume (FEV1) |
| Spirometry FVC | Minute 0 before start of product use session, Minute 60 of product use session | Spirometry will be used to measure forced vital capacity (FVC) |
| Spirometry FEV1/FVC | Minute 0 before start of product use session, Minute 60 of product use session | Spirometry will be used to measure FEV1/FVC |
| Used filter count | Minute 60 of product use session | Will assess the number of study product consumed |
| Harm Perception | Minute 60 of product use session | A harm perception questionnaire will be used to assess the relative and absolute perceived harm of IQOS products. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORAlayna P Tackett, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed