Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age

2019-09-23 04:51:46 | BioPortfolio


Despite marked reductions in cigarette smoking in the general population, smoking rates among economically disadvantaged women have increased. Smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. A national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in these smokers. Controlled trials in general population samples have demonstrated that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence severity, and tobacco toxicant exposure.

The goal of the proposed trial is to experimentally examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effects of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age. Additionally, we will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking.

Daily smokers who are female, aged 18-44 years, and have a maximum educational attainment of graduating high school, will be recruited at Johns Hopkins University and the University of Vermont.

We will study two research cigarettes referred to here as RC1 and RC2. One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. We will study two e-cigarette conditions referred to here as EC1 and EC2. Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2.

Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).

Study Design


Tobacco Use Disorder


Cigarettes with varying nicotine content, E-Cigarettes


Not yet recruiting


University of Vermont

Results (where available)

View Results


Published on BioPortfolio: 2019-09-23T04:51:46-0400

Clinical Trials [1754 Associated Clinical Trials listed on BioPortfolio]

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked, ...

Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive con...

Low Nicotine Cigarettes Plus Electronic Cigarettes

This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among...

Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limite...

Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducin...

PubMed Articles [11372 Associated PubMed Articles listed on BioPortfolio]

The educational gap in tar and nicotine content in purchases of cigarettes: An observational study using large-scale representative survey data from Japan.

The intensity of tobacco use is commonly measured by the number of cigarettes, which is inaccurate because it masks the heterogeneity and substances contained in tobacco. Unlike existing studies, this...

Strategies to Reduce Illicit Trade of Regular Nicotine Tobacco Products After Introduction of a Low-Nicotine Tobacco Product Standard.

The US Food and Drug Administration is considering mandating a substantial reduction in the nicotine level of cigarettes and possibly other combusted tobacco products to render them minimially addicti...

Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine.

A mandated reduction in the nicotine content of cigarettes may decrease smoking, but also increase demand for other nicotine products. The present study tested the impact of smoking cigarettes with ve...

E-Cigarettes and Health - The Cons.

E-cigarettes are not a safe alternative to cigarettes, and may substantially increase cardiovascular and lung disease risks. Rather than stimulating smokers to switch from conventional cigarettes to e...

Impact of Brief Nicotine Messaging on Nicotine-Related Beliefs in a U.S. Sample.

The current study pilot tested the effect of a single, brief exposure to nicotine education messages on beliefs about nicotine, nicotine-replacement therapy (NRT), E-cigarettes, and cigarettes with re...

Medical and Biotech [MESH] Definitions

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

The act of inhaling and exhaling vapors produced from ELECTRONIC CIGARETTES.


Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

More From BioPortfolio on "Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age"

Quick Search

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Searches Linking to this Trial