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Can Ultra-Low nicotine cigarettes help pregnant smokers cut down?

NCT ID NCT04033237

Disease control Sponsor: University of Vermont Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving pregnant smokers cigarettes with very low nicotine (0.4 mg per gram of tobacco) helps them smoke less over 12 weeks. Thirty women were randomly assigned to either their usual brand or the low-nicotine cigarettes. The main goal was to see if they smoked fewer cigarettes per day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
very low nicotine cigarettes (0.4 mg nicotine/g tobacco)
What this could lead to
If successful, this could show that reducing nicotine in cigarettes helps pregnant women smoke less, potentially leading to safer tobacco policies.
What could go wrong
This is a small early-phase study with only 30 participants, so results may not apply to all pregnant smokers. The intervention still involves smoking, which carries health risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 44 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female * Ages 18-44 years * Gestational age ≤ 25 weeks Exclusion Criteria: * Male * Under 18 years old * Over 44 years old * Gestational age \> 25 weeks

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Conditions

The condition(s) this trial relates to.

nicotine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tobacco use disorder

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

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Other studies related to the condition(s) this trial covers.