# Evaluating New Nicotine Standards for Cigarettes - Project 1

> **NIH NIH U54** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $742,453

## Abstract

PROJECT SUMMARY/ABSTRACT
 In the United States, there are 44 million smokers and about 500,000 tobacco related deaths yearly.
The 2014 Surgeon General's Report stated, “ The burden of death and disease from tobacco use in the
United States is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid
elimination of their use will dramatically reduce this burden.” Although comprehensive tobacco control
measures have had a significant impact in reducing smoking, because nearly 1 out 5 Americans still
smoke, novel tobacco control approaches to reduce combusted tobacco product use are needed. One
of the most powerful tools granted to the Food and Drug Administration through the 2009 Family
Smoking Prevention and Tobacco Control Act is the authority to establish product standards, which
includes standards for nicotine to render the cigarette minimally addictive. This regulatory policy could
have a profound impact on public health by minimizing the transition from experimental cigarette use to
dependence, facilitating quit attempts, and reducing the occurrence of relapse. To date, studies
conducted examining the effects of reducing nicotine to very low levels (e.g., 0.4 mg/g nicotine) are
promising and show a reduction in smoking and dependence relative to normal nicotine content
cigarettes and an increase in quit attempts. However, the majority of these studies, although strong
experimentally, were not conducted in the context of a complex marketplace and as such the results
from these studies may not adequately represent the full public health impact of reducing nicotine in
cigarettes. For example, these studies provided study cigarettes at no cost, discouraged the use of
other tobacco or nicotine products, blinded smokers to the dose of nicotine and had restrictive inclusion
criteria. Project 1 will circumvent these limitations, simulating the “real world” environment by providing
participants access to an experimental marketplace where they will be given vouchers that can be
exchanged for study cigarettes (varying in nicotine content) and non-combusted tobacco/nicotine
products or cash, by informing participants about the nicotine content in cigarettes, and by broadening
the criteria for study inclusion. More specifically, subjects (N=350 in each group) will be randomly
assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted
tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non-
combusted tobacco/nicotine products. We hypothesize that the VLNC cigarette condition will lead to: 1)
greater use of non-combusted products; 2) fewer cigarettes smoked; 3) less exposure to tobacco-
related toxicants; and 4) greater number of days of cigarette abstinence. We also hypothesize that
VLNC will be associated with less positive effects than NNC, and greater positive effects of alternative
non-combusted products than in the NNC condition. Finally, we hypothesiz...

## Key facts

- **NIH application ID:** 10122933
- **Project number:** 5U54DA031659-10
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** DOROTHY K HATSUKAMI
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $742,453
- **Award type:** 5
- **Project period:** 2011-09-15 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122933

## Citation

> US National Institutes of Health, RePORTER application 10122933, Evaluating New Nicotine Standards for Cigarettes - Project 1 (5U54DA031659-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10122933. Licensed CC0.

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