The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Tobacco Use

Treatments: Device: Tobacco product administration and assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05499377

1F30DA057047 (U.S. NIH Grant/Contract)

HM20024873

U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Tobacco-Flavored IQOS

Active Comparator group

Description:

Tobacco - where menthol smokers will only have access to tobacco-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System

Treatment:

Device: Tobacco product administration and assessment

Menthol-Flavored IQOS

Experimental group

Description:

Menthol - where menthol smokers will only have access to menthol-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System

Treatment:

Device: Tobacco product administration and assessment