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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: Completed NA study, sponsored by University of Vermont.

NCT04092387 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 326 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Cigarettes per day will be assessed for use of cigarettes with different nicotine content.

Interventions

  • OTHER Varying the nicotine content of cigarettes
  • OTHER E-Cigarettes

Trial Details

FieldValue
Enrollment Target 326 participants
Start Date 2020-10-18
Est. Completion 2023-11-27
Phase NA
University of Vermont

162 total trials

What the finished NCT04092387 record still lists

NCT04092387 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Varying the nicotine content of cigarettes is the first listed.

NCT04092387 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04092387's enrollment target sits among peer trials

326 310th of 2000 higher than 1,690 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04092387, the US trial registry maintained by the National Library of Medicine. NCT04092387 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.