Tobacco Use DisorderPhase 1/2NCT04033237
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
A Phase 1/2 study testing Very low nicotine content cigarettes in people with Tobacco Use Disorder, run by University of Vermont at 2 sites in United States.
Trial summary
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Very low nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2019to 19 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Ages 18-44 years
- Gestational age ≤ 25 weeks
Who cannot join
- Male
- Under 18 years old
- Over 44 years old
- Gestational age > 25 weeks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont
Burlington, Vermont, 05401
University of Kentucky
Lexington, Kentucky, 40536
About this study
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
Read the detailed description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
- Conditions
- Tobacco Use Disorder
- Being tested
- Very low nicotine content cigarettes
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Pregnancy, Health disparities, Vulnerable populations
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesOther
Cigarettes containing 0.4 mg nicotine/g tobacco
| Study group | Role | What they receive |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Not described Receives: Other: Very low nicotine content cigarettes |
| Usual Brand | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cigarettes Per Day
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start21 Aug 2019
- Primary completion17 Apr 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), University of Kentucky
- Responsible party
- Principal investigator, Sarah Heil, University of Vermont
- Investigators
- Sarah H. Heil, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033237
- Sponsor's protocol ID
- CHRMS 16-390
- Other IDs
- U54DA036114
- Status last verified
- May 2026
- First submitted
- 23 Jul 2019
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heil SH, Kock LS, Harfmann RF, Ashford KB, Barnett J, McCubbin A, DeSarno MJ, Higgins ST. Pilot randomized clinical trial examining use of very low nicotine content cigarettes during pregnancy in the United States. Prev Med. 2025 Dec;201:108351. doi: 10.1016/j.ypmed.2025.108351. Epub 2025 Jul 5.
PubMed 40623557
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
- ClinicalTrials.gov ID
- NCT04033237
- Acronym / sponsor ID
- CHRMS 16-390
- Conditions
- Tobacco Use Disorder
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Pregnancy, Health disparities
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), University of Kentucky
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
Detailed description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Other: Very low nicotine content cigarettes |
| Usual Brand | No intervention | – |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Ages 18-44 years
- Gestational age ≤ 25 weeks
Key exclusion criteria (4 listed)
- Male
- Under 18 years old
- Over 44 years old
- Gestational age > 25 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low nicotine content cigarettesCigarettes containing 0.4 mg nicotine/g tobacco | Other | Very low nicotine content cigarettes |
Primary outcome
Total Cigarettes Per Day
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40623557Heil SH, Kock LS, Harfmann RF, Ashford KB, Barnett J, McCubbin A, DeSarno MJ, Higgins ST. Pilot randomized clinical trial examining use of very low nicotine content cigarettes during pregnancy in the United States. Prev Med. 2025 Dec;201:108351. doi: 10.1016/j.ypmed.2025.108351. Epub 2025 Jul 5.
Related trials for Tobacco Use Disorder
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
Hypertension, Tobacco Cigarette Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah H. Heil principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Very low nicotine content cigarettes in people with Tobacco Use Disorder, run by University of Vermont at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cigarettes Per Day (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.