Clinical trial NCT05499377: The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute
Official title: Effects of Heated Tobacco Product Flavor on Tobacco Use Behavior and Abuse Liability Among Menthol Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Heated Tobacco Products
Flavor
Abuse Liability
Tobacco
Cigarettes
Menthol
Experimental Tobacco Marketplace
Nicotine Delivery
Puff Topography
Ecological Momentary Assessment
Modified Risk Tobacco Product
IQOS
Heated Tobacco Products Flavors
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-08-12
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project examines the influence of flavor availability on switching to an MRTP known as IQOS, part of the Heated Tobacco Product (HTP) class, among menthol smokers using clinical lab and naturalistic evaluations of abuse liability. Results will help federal regulators predict the public health impact on menthol cigarette smokers of policies restricting access to menthol-flavored HTPs.

Detailed description: The public health success of FDA's proposed ban on menthol cigarettes hinges upon whether menthol smokers who are unable to quit smoking switch to non-menthol cigarettes (no public health gain) or to potentially lower harm alternatives like heated tobacco products (HTP). In 2019, FDA authorized an HTP called "IQOS" and its tobacco- and menthol-flavored "HeatSticks" (HS) as a modified risk tobacco product (MRTP). One issue relevant to FDA's future action regarding IQOS will be "whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products" (FDA, 2018). Understanding the potential for HTPs like IQOS to reduce the health burden of cigarettes requires targeted research investigating the extent to which flavor availability is important for menthol smokers to switch to HTPs. For one tobacco product to substitute for another, their abuse liabilities should be congruent. Validated clinical lab methods exist for comparing tobacco product abuse liability by characterizing their nicotine delivery profiles (via plasma nicotine and puff topography) and reinforcing efficacy (via subjective and behavioral measures). Naturalistic assessment can validate clinical lab results regarding use patterns and product substitution.

The current study involves a two-arm, two-week, parallel group trial. The first week is an own brand (OB) menthol cigarette baseline, during which tobacco use will be assessed daily using ecological momentary assessment (EMA). On Monday and Friday, participants will complete clinical lab sessions that involve using OB cigarettes and responding to subjective measures and an Experimental Tobacco Marketplace (ETM) task that assesses willingness to substitute menthol cigarettes with an array of tobacco products including IQOS. During the next week, participants will be randomized to receive IQOS-menthol (n=25) or IQOS-tobacco (n=25); EMA and clinical lab visits will be repeated. Aim 1 assesses IQOS' abuse liability in a clinical lab setting. Outcomes include plasma nicotine levels, puffing behavior, responses about subjective effects, and product substitution from the ETM task. Aim 2 measures tobacco use patterns in naturalistic settings where participants will report daily OB and IQOS use outcomes via EMA. The overarching hypothesis is that, relative to OB, IQOS-menthol's abuse liability profile will differ less than IQOS-tobacco's, suggesting that menthol smokers will be more likely to substitute an HTP for combustible menthol cigarettes when a menthol-flavored HTP is available. Results will deepen our understanding of the public health impact of HTPs and policies that might restrict access to menthol-flavored MRTPs.

Eligibility criteria: Inclusion Criteria:

* Healthy adults (aged 21 and older)
* Daily menthol cigarette smokers
* Exhaled Carbon Monoxide (CO) reading of \> 5 PPM at in-person screening (to confirm smoking status)
* A 'positive' cotinine cassette result to verify nicotine use at the in-person screening.
* Participants must be willing to provide informed consent and abstain from nicotine/tobacco for ≥8 hours prior to each lab session.
* Participants must have access to a computer/smartphone and be willing to receive and respond to daily surveys
* Able to read and write in English

Exclusion Criteria:

* Daily use of any tobacco products other than cigarettes
* Self-reported history of chronic medical or psychiatric conditions
* Women will be excluded if they test positive for pregnancy (by urinalysis) or self-report breastfeeding.

Some details of the study inclusion and exclusion criteria are omitted at this time, to preserve scientific integrity. Full inclusion and exclusion criteria will be posted following study completion.

Primary outcomes:
measure: Percent Change in Average Daily Cigarette Use Per Day From Baseline
timeFrame: Week 1 (baseline) to Week 2 (intervention)
measure: Percent Increase in Demand as the Subject is Willing to Substitute From Cigarettes to HTPs Using the Experimental Tobacco Marketplace Task
timeFrame: Week 2, Friday Clinical Lab visit
measure: Plasma Nicotine Delivery
timeFrame: Week 2, Friday Clinical Lab visit (10 puff bout period)
Secondary outcomes:
measure: Cigarette Craving Suppression Questionnaire
timeFrame: Week 2, Friday Clinical Lab Visit (10 puff bout period)
measure: Puff Topography (Puff Duration)
timeFrame: Week 2, Friday Clinical Lab visit (10 puff bout period)
measure: Average Daily IQOS Usage
timeFrame: Week 2 (intervention week), Tuesday-Thursday
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Andrew J Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: