# Evaluationg the effects of e-cigarettes vs. oral nicotine pouches and product constituents (menthol flavor, nicotine concentration) on adult cigarette smoking and addiction

> **NIH NIH U54** · YALE UNIVERSITY · 2024 · $347,171

## Abstract

PROJECT 4 ABSTRACT
Cigarette smoking remains the leading cause of preventable disease and death. Thus, better population-based
strategies are urgently needed to reduce cigarette smoking and tobacco-related harm. One approach is to
improve regulation of cigarettes and other tobacco products, which is a core mission of the U.S. Food and
Drug Administration (FDA) under the Tobacco Control Act. Indeed, the FDA has signaled its intention to ban
menthol and lower nicotine concentrations in cigarettes to protect public health. The FDA may consider similar
product standards that restrict flavors and lower nicotine concentrations in non-combustible products as well.
However, scientific data is needed to understand the impact of these regulations. For example, the FDA has
approved only tobacco flavored e-cigarettes for marketing so far, in both high and moderate nicotine
concentrations, and is still evaluating premarket tobacco product applications for menthol non-combustible
products. Although e-cigarettes and pouches may help adults reduce smoking and smoking-related harm, it
remains to be determined whether menthol flavor and higher nicotine concentrations in non-combustible
products are important for cigarette substitution in adults. To inform tobacco regulatory policies of e-cigs and
pouches, we propose to conduct a controlled trial of the effects of non-combustible tobacco product
type and constituents on smoking behaviors in adults. Specifically, we will randomize adults who currently
smoke cigarettes (N=256) to switch to either e-cigs or pouches for 4-weeks and will also randomly assign
participants to four possible regulatory scenarios within product where flavor availability is either menthol and
tobacco/unflavored or tobacco/unflavored only, and nicotine concentration is either high (5% e-cig or 6mg
pouch) or moderate (2.4% e-cig or 3mg pouch). The design will yield 8 conditions (N=32 participants each).
Data from these participants will be used to compare the effects of product type, flavor availability, and nicotine
concentration on cigarette smoking behaviors and dependence using validated self-report measures and
biomarkers (Aim 1), and to assess the effects of these conditions on e-cig/pouch use behaviors and appeal
using validated self-report measures and biomarkers (Aim 2). In addition, we will explore potential interactions
between conditions (e.g., flavor availability and nicotine concentration) and participant characteristics (sex,
race/ethnicity, menthol cigarette preference, and baseline nicotine dependence level) (Aim 3). Our analyses
will provide key information on which individuals may be more likely to switch completely from smoking to non-
combustible products and whether certain flavors or nicotine concentrations in these products are important for
cigarette substitution and appeal among adults. This project focuses on key FDA priority areas of behavior,
addiction, and impact analysis. Our results will provide crucial evidence ...

## Key facts

- **NIH application ID:** 10934555
- **Project number:** 5U54DA036151-12
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** LISA M FUCITO
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $347,171
- **Award type:** 5
- **Project period:** 2013-09-30 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10934555

## Citation

> US National Institutes of Health, RePORTER application 10934555, Evaluationg the effects of e-cigarettes vs. oral nicotine pouches and product constituents (menthol flavor, nicotine concentration) on adult cigarette smoking and addiction (5U54DA036151-12). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10934555. Licensed CC0.

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