# Low Nicotine Content Cigarettes in Vulnerable Populations:  Opioid Abusers

> **NIH NIH U54** · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · 2021 · $684,684

## Abstract

Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US
adult population. Smoking is also associated with significant morbidity and mortality in this population, with the
mortality rate of opioid-dependent smokers four times that of opioid-dependent nonsmokers and quit rates of
approximately one-fourth that of non-substance abusers. A national policy of reducing the nicotine content of
cigarettes has the potential to be an effective method of reducing the prevalence of smoking and smoking-
related adverse health outcomes in this vulnerable population. Controlled trials in the general population of
smokers have demonstrated that switching smokers to very low nicotine content (VLNC) cigarettes results in
reductions in cigarettes per day, cigarette dependence, and tobacco toxicant exposure, with few adverse
consequences. Furthermore, our work during the current funding period indicates that smokers with OUD
respond to reductions in the nicotine content of cigarettes with reductions in cigarette demand and other
measures of addiction potential, although to a lesser extent that the other vulnerable smoker populations we
have been examining. Considering the serious smoking-related disparities and adverse health consequences
in the population of opioid-dependent smokers, we believe that an approach that combines e-cigarettes and
also preferred flavoring represents a set of conditions most likely to produce a maximal effect on combustible
smoking. Thus during the next funding period, we will utilize principles and methods of behavioral economics
and behavioral pharmacology as we extend our research by examining the effects of reducing the nicotine
content of cigarettes on cigarette smoking in this vulnerable population with and without substitute non-
combusted nicotine products (i.e., e-cigarettes) readily available. We will also examine whether appeal of the
non-combusted alternative is enhanced by flavors. In a multi-site, randomized clinical trial, we will use a
between-subject, four parallel group, research design to evaluate the effects of VLNC cigarettes on smoking
rate, dependence severity, and tobacco toxin exposure in smokers with current OUD. Participants will be
randomly assigned to 16 weeks of exposure to (1) normal nicotine content cigarettes alone, which will serve as
the control condition, (2) VLNC cigarettes alone, (3) VLNCs + tobacco-flavored nicotinized e-cigarettes, or (4)
VLNCs + nicotinized e-cigarette with preferred flavoring. This design will be of direct utility to the FDA CTP by
modeling possible market scenarios in which a reduced nicotine content policy may be implemented. Overall,
this proposal has the potential to continue a productive multidisciplinary research program that focuses on the
most vulnerable and least studied populations of tobacco users. This project will provide FDA CTP with
critically important empirical evidence relevant to its regulatory responsibilities, w...

## Key facts

- **NIH application ID:** 10247027
- **Project number:** 5U54DA036114-09
- **Recipient organization:** UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
- **Principal Investigator:** STACEY C SIGMON
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $684,684
- **Award type:** 5
- **Project period:** 2013-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247027

## Citation

> US National Institutes of Health, RePORTER application 10247027, Low Nicotine Content Cigarettes in Vulnerable Populations:  Opioid Abusers (5U54DA036114-09). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10247027. Licensed CC0.

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