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NCT04092387 · ClinicalTrials.gov registry record · NA
Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 326
- Enrollment target
NCT04092387 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 326 participants.
The verdict
NCT04092387, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 326 participants
- Enrollment target
Study 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 partic
Interventions
- OTHER Varying the nicotine content of cigarettes
- OTHER E-Cigarettes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2020-10-18 |
| Est. Completion | 2023-11-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04092387
The ClinicalTrials.gov registry entry for NCT04092387 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Varying the nicotine content of cigarettes is the first listed.
NCT04092387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04092387 about?
NCT04092387 is a clinical study titled "Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age". 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 pregnan...
What is the current status of trial NCT04092387?
This trial is currently completed. It is a NA study. The enrollment target is 326 participants. The study started on 2020-10-18. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT04092387?
The interventions under investigation include: Varying the nicotine content of cigarettes (OTHER), E-Cigarettes (OTHER).
Who is sponsoring clinical trial NCT04092387?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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