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

> **NIH NIH F30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2022 · $46,300

## Abstract

PROJECT SUMMARY/ABSTRACT
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. Moreover, this application describes an excellent research
environment for the proposed work, supported by a collaborative mentorship team with relevant expertise.
Resultantly, the applicant will learn new skills in clinical lab assessmen...

## Key facts

- **NIH application ID:** 10535281
- **Project number:** 1F30DA057047-01
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Augustus Michael White
- **Activity code:** F30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $46,300
- **Award type:** 1
- **Project period:** 2022-07-28 → 2027-07-27

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10535281

## Citation

> US National Institutes of Health, RePORTER application 10535281, The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute. (1F30DA057047-01). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10535281. Licensed CC0.

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