# Evaluating New Nicotine Standards for Cigarettes - Project 3

> **NIH NIH U54** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $363,304

## Abstract

PROJECT SUMMARY
Adolescence is a critical developmental period for tobacco initiation and progression to regular use and
dependence. Comprehensive tobacco control policies that reduce the reinforcing effects of cigarettes in
adolescents may decrease the number of cigarette experimenters who go on to become lifelong smokers. With
the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, the Food and Drug
Administration (FDA) was granted the authority to establish standards for tobacco products as appropriate for
the protection of public health, including the authority to mandate a reduction in the nicotine content of all
cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to
very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine
dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC)
cigarettes. However, to date, studies of VLNC cigarettes have excluded adolescent smokers, and are critically
needed to inform potential product standards. Furthermore, as use of electronic cigarettes (e-cigarettes) has
increased dramatically in adolescents, effects of VLNC cigarettes on smoking in youth must be examined in
the context of e-cigarette availability. Project 3 is a 2 x 2 x 2 mixed-factors laboratory study in which a smoking
choice procedure will be used to determine how the nicotine content of cigarettes and key characteristics of e-
cigarettes (nicotine concentration and flavors) influence use of these products and their subjective effects in
adolescents. In this single-site study, adolescents aged 15-19 (N=120), who are daily cigarette smokers and
have used e-cigarettes on at least 5 occasions, will first complete a baseline session in which eligibility criteria
are confirmed, background questionnaires are completed and participants gain experience with the e-cigarette
device to be used in later sessions. Next, participants will complete 5 lab sessions in which NNC (15.8 mg/g) or
VLNC (0.4 mg/g) cigarettes are available and e-cigarettes varying in nicotine concentration (2 mg/mL or 18
mg/mL) and flavor (tobacco or non-tobacco) are concurrently available. After sampling and rating the
subjective effects of each product, participants will make a series of 10 choices between 2 puffs of either
product or abstinence. An additional lab session during which e-cigarettes are not available will allow a direct
comparison of the effects of NNC and VLNC cigarettes on smoking when no alternative product is available.
We hypothesize that reducing the nicotine content of cigarettes will reduce cigarette choices and increase both
e-cigarette choices and choices to abstain from either product. We further hypothesize that e-cigarettes with
higher nicotine concentration and non-tobacco flavor will be most effective at reducing cigarette choices. We
will also test the impact of these factors on the subje...

## Key facts

- **NIH application ID:** 10122936
- **Project number:** 5U54DA031659-10
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** SUZANNE M COLBY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $363,304
- **Award type:** 5
- **Project period:** 2011-09-15 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122936

## Citation

> US National Institutes of Health, RePORTER application 10122936, Evaluating New Nicotine Standards for Cigarettes - Project 3 (5U54DA031659-10). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10122936. Licensed CC0.

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