Clinical trial NCT04092387: Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Official title: Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Biomarkers of Exposure
Nicotine Dependence
Reduced Nicotine Cigarettes
Tobacco Withdrawal
Women
Health Disparities
Vulnerable Populations
E-Cigarettes
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
name: Johns Hopkins University
First posted: 2019-09-17
Enrollment: 326
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel groups research design.
Primary purpose: PREVENTION

Brief summary: Despite marked reductions in cigarette smoking in the general population, smoking among economically disadvantaged women has 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 this population. 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) enhances the effect 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 21-44 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 will be a normal nicotine content cigarette and the other 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 the e-liquid will be available in multiple flavors from which participants can choose three based on personal preference. Participants will be assigned to one of the following four 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, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), other biomarkers of tobacco toxicant exposure, and cigarette demand assessed by behavioral economic purchase tasks.


Eligibility criteria: Inclusion Criteria:

* Female
* 21 to 44 years old

Exclusion Criteria:

* Male
* Under 21 years old
* Over 44 years old

Primary outcomes:
measure: Number of Cigarettes Smoked Per Day
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Stephen T. Higgins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: