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

Study Overview
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Brief Summary
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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, investigators 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. Investigators will study two research cigarettes referred to here as Research Cigarettes 1 (RC1) and Research Cigarettes 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (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]).

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

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Other: Cigarettes with varying nicotine content
* Other: E-Cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 21 to 44 years old Exclusion Criteria: Male Under 21 years old Over 44 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel groups research design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC 1 only<br>Research cigarettes #1 | Other: Cigarettes with varying nicotine content<br>* 1) Altering the nicotine content of the tobacco research cigarettes<br>|
| Experimental: RC 2 only<br>Research Cigarettes #2 | Other: Cigarettes with varying nicotine content<br>* 1) Altering the nicotine content of the tobacco research cigarettes<br>|
| Experimental: RC 2 + EC 1<br>Research Cigarettes #2 plus E-cigarettes #1 | Other: Cigarettes with varying nicotine content<br>* 1) Altering the nicotine content of the tobacco research cigarettes<br>Other: E-Cigarettes<br>* 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig conditions<br>|
| Experimental: RC 2 + EC 2<br>Research Cigarettes #2 plus E-cigarettes #2 | Other: Cigarettes with varying nicotine content<br>* 1) Altering the nicotine content of the tobacco research cigarettes<br>Other: E-Cigarettes<br>* 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cigarettes Smoked Per Day | Cigarettes per day will be assessed for use of cigarettes with different nicotine content. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of Exposure, Compensatory Smoking, Nicotine Dependence, Reduced Nicotine Cigarettes, Tobacco Withdrawal, Women, Health Disparities, Vulnerable Populations, E-Cigarettes