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

Ohio State University Comprehensive Cancer Center30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Tobacco

Interventions

Smoking Behavioral Research (IQOS)BEHAVIORAL

Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)

Smoking Behavioral Research (UBC)BEHAVIORAL

Smoke UBC

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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 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.

Time frame: 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.

Time frame: 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).

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

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.

Central Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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 session

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 session

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 session

Used filter count

Will assess the number of study product consumed

Time frame: 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.

Time frame: Minute 60 of product use session