# Evaluating New Nicotine Standards for Cigarettes - Project 2

> **NIH NIH U54** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2020 · $947,560

## Abstract

PROJECT SUMMARY 
 Decades of research suggest nicotine is the primary psychoactive constituent of tobacco that results in 
dependence. Consistent with this extensive literature and their regulatory authority to reduce (but not eliminate) 
nicotine, the Food and Drug Administration has identified nicotine products standards that target the appeal and 
addictiveness of cigarettes as a top research priority. Evidence to date suggests that smokers who are switched 
to reduced nicotine cigarettes reduce the number of cigarettes they smoke, reduce their exposure to nicotine 
and toxicants, and report less cigarette dependence. However, the implications of these observations are 
complicated by the fact that few smokers actually quit smoking and most supplement their use of reduced 
nicotine cigarettes with commercially available, non-study cigarettes that contain normal amounts of nicotine. If 
normal nicotine content cigarettes were largely unavailable as a result of regulation, many smokers may turn to 
alternative products, particularly e-cigarettes. The degree to which e-cigarettes facilitate further reductions in 
smoking, or cessation, will likely depend on characteristics of e-cigarettes that impact their reinforcing effects 
relative to conventional cigarettes. In particular, both nicotine concentration and availability of a variety of flavors 
may affect the degree to which e-cigarettes substitute for cigarettes. Consequently, Project 2 examines how 
three factors – the nicotine content of cigarettes, the nicotine concentration of e-cigarettes, and the availability 
of both tobacco and non-tobacco flavors of e-cigarettes interact to determine whether current smokers reduce 
or stop smoking. Participants (N=480) at two sites will be randomized in a 2x2x2 design to receive A) cigarettes 
with 0.4 mg/g vs. 15.8 mg/g nicotine; B) e-cigarettes in tobacco only vs. tobacco and non-tobacco flavors; and 
C) e-cigarettes with 2 vs. 18 mg/ml nicotine. For 7 weeks, participants will be given a full supply of both cigarettes 
and e-cigarettes. During the last week, participants will be given monetary incentives to abstain from smoking 
tobacco. Equal numbers of younger (18-24) v. older (25+) and male v. female smokers will be recruited. We 
hypothesize that reducing nicotine in cigarettes will reduce cigarettes smoked, cigarette dependence, and 
exposure to toxicants while increasing use of e-cigarettes and the ability to abstain from smoking. We further 
predict that these effects will be greater when participants are provided e-cigarettes with higher nicotine 
concentration and both tobacco and non-tobacco flavors. We will also test the impact of condition on the 
subjective effects of each product and explore whether the behavioral and subjective effects vary as a function 
of age and gender. In summary, the proposed study will provide the Food and Drug Administration with critically 
important information directly related to potential products standard...

## Key facts

- **NIH application ID:** 9889097
- **Project number:** 5U54DA031659-09
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** ERIC Christian DONNY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $947,560
- **Award type:** 5
- **Project period:** — → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9889097

## Citation

> US National Institutes of Health, RePORTER application 9889097, Evaluating New Nicotine Standards for Cigarettes - Project 2 (5U54DA031659-09). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9889097. Licensed CC0.

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