# Low Nicotine Content Cigarettes in Vulnerable Populations:  Affective Disorders

> **NIH NIH U54** · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · 2021 · $734,543

## Abstract

Affective disorders (ADs; mood and anxiety disorders) are the most common mental health conditions in the 
US. Over 40% of people with ADs are current smokers, and they experience disproportionately high rates of 
tobacco-related disease and death. A national nicotine reduction policy for cigarettes has the potential to reduce 
tobacco dependence and improve health in these smokers. Controlled trials in general population samples have 
demonstrated that switching smokers to very low nicotine content cigarettes (VLNCCs) results in reductions in 
cigarettes per day (CPD), cigarette dependence, and tobacco toxicant exposure, with few adverse 
consequences. Furthermore, our work during the current funding period indicates that smokers with ADs respond 
to VLNCCs with reductions in cigarette demand and other measures of addiction. However, tobacco market 
conditions are likely to exert considerable influence over the effectiveness of a cigarette nicotine reduction policy. 
During the next funding period, we will utilize principles and methods of behavioral economics and behavioral 
pharmacology to examine the effects of VLNCCs in smokers with ADs, either alone or while providing a substitute 
non-combusted source of nicotine (e-cigarettes). In separate conditions, e-cigarettes will be provided in tobacco 
flavors only or in appealing personalized flavors. This multi-site trial uses a four parallel group, pragmatic design. 
Daily smokers with ADs will be randomized to 16 weeks of: (1) normal nicotine content cigarettes (NNCCs) alone, 
the control condition, (2) VLNCCs alone, (3) VLNCCs + nicotinized, tobacco-flavored (TF e-cigs), or (4) VLNCCs 
+ nicotinized, preferred-flavored e-cigs (PF e-cigs). Outcome measures include CPD, product demand, craving, 
appeal, psychiatric symptoms, biomarkers of brain function, and biomarkers of tobacco toxicant exposure and 
airway inflammation. After 16 weeks of use, participants will undergo an abstinence assessment in which we 
examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses 
to abstinence. The integrative theme of this TCORS is vulnerable populations. The proposed research is highly 
relevant to CTP’s scientific domains of Addiction and Behavior because it will examine whether reducing the 
nicotine content of cigarettes reduces cigarette use, dependence, and product appeal, and whether these effects 
are enhanced by the availability of e-cigarettes. It will address the Health Effects domain by assessing the 
effects of these conditions on biomarkers of brain function, tobacco toxicant exposure, and airway inflammation. 
The proposed study is significant and innovative because it will model how availability and appeal of e-cigs 
may moderate the effectiveness of a national reduced-nicotine policy for cigarettes in an understudied 
population. Finally, it is programmatic, as it will build upon the work that we accomplished during the current 
fundi...

## Key facts

- **NIH application ID:** 10247028
- **Project number:** 5U54DA036114-09
- **Recipient organization:** UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
- **Principal Investigator:** JENNIFER W. TIDEY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $734,543
- **Award type:** 5
- **Project period:** 2013-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247028

## Citation

> US National Institutes of Health, RePORTER application 10247028, Low Nicotine Content Cigarettes in Vulnerable Populations:  Affective Disorders (5U54DA036114-09). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10247028. Licensed CC0.

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