Tobacco Use DisorderNCT04092387
Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
A study testing Varying the nicotine content of cigarettes and E-Cigarettes in people with Tobacco Use Disorder, run by University of Vermont at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Varying the nicotine content of cigarettes and E-Cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2020to 27 Nov 2023
- Phase
- Interventional
- 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 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 21 to 44 years old
Who cannot join
- Male
- Under 21 years old
- Over 44 years old
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Vermont
Burlington, Vermont, 05401
About this study
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.
Read more
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Varying the nicotine content of cigarettes, E-Cigarettes
- Keywords
- Biomarkers of Exposure, Nicotine Dependence, Reduced Nicotine Cigarettes, Tobacco Withdrawal, Women, Health Disparities, Vulnerable Populations, E-Cigarettes
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varying the nicotine content of cigarettesOther
Also called Comparing normal nicotine content (RC1) to very low nicotine content (RC2)
- Altering the nicotine content of the tobacco research cigarettes
E-CigarettesOther
Also called e-cigarette with only tobacco flavor (EC 1); e-cigarette in multiple flavors ( EC2)
Comparing effects of combining RC2 with EC 1 versus EC2
| Study group | Role | What they receive |
|---|---|---|
| RC 1 only | Experimental | Research cigarettes #1 Receives: Other: Varying the nicotine content of cigarettes |
| RC 2 only | Experimental | Research Cigarettes #2 Receives: Other: Varying the nicotine content of cigarettes |
| RC 2 + EC 1 | Experimental | Research Cigarettes #2 plus E-cigarettes #1 Receives: Other: Varying the nicotine content of cigarettes; Other: E-Cigarettes |
| RC 2 + EC 2 | Experimental | Research Cigarettes #2 plus E-cigarettes #2 Receives: Other: Varying the nicotine content of cigarettes; Other: E-Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cigarettes Smoked Per Day
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start18 Oct 2020
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
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 (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel groups research design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 326 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), Johns Hopkins University
- Responsible party
- Principal investigator, Stephen T. Higgins, PhD, University of Vermont
- Investigators
- Stephen T. Higgins, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092387
- Sponsor's protocol ID
- CHRMS19-0129
- Other IDs
- U54DA036114-06
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2019
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data
Publications
Nolder KA, Erath TG, DeSarno MJ, Klemperer EM, Higgins ST. A further examination of the validity of assessing demand intensity using the Cigarette Purchase Task. Exp Clin Psychopharmacol. 2026 Aug 6:10.1037/pha0000874. doi: 10.1037/pha0000874. Online ahead of print.
PubMed 42560883Higgins ST, Sigmon SC, Tidey JW, Heil SH, Gaalema DE, Lee DC, DeSarno MJ, Klemperer EM, Menson KE, Cioe PA, Plucinski S, Wiley RC, Orr E. Reduced Nicotine Cigarettes and E-Cigarettes in High-Risk Populations: 3 Randomized Clinical Trials. JAMA Netw Open. 2024 Sep 3;7(9):e2431731. doi: 10.1001/jamanetworkopen.2024.31731.
PubMed 39240566
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT04092387
- Acronym / sponsor ID
- CHRMS19-0129
- Conditions
- Tobacco Use Disorder
- Keywords
- Biomarkers of Exposure, Nicotine Dependence, Reduced Nicotine Cigarettes, Tobacco Withdrawal, Women, Health Disparities, Vulnerable Populations, E-Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), Johns Hopkins University
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized parallel groups research design.
| Arm | Type | Receives |
|---|---|---|
| RC 1 only | Experimental | Other: Varying the nicotine content of cigarettesResearch cigarettes #1 |
| RC 2 only | Experimental | Other: Varying the nicotine content of cigarettesResearch Cigarettes #2 |
| RC 2 + EC 1 | Experimental | Other: Varying the nicotine content of cigarettes, Other: E-CigarettesResearch Cigarettes #2 plus E-cigarettes #1 |
| RC 2 + EC 2 | Experimental | Other: Varying the nicotine content of cigarettes, Other: E-CigarettesResearch Cigarettes #2 plus E-cigarettes #2 |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- 21 to 44 years old
Key exclusion criteria (3 listed)
- Male
- Under 21 years old
- Over 44 years old
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 |
|---|---|---|
| Varying the nicotine content of cigarettesAlso: Comparing normal nicotine content (RC1) to very low nicotine content (RC2)1) Altering the nicotine content of the tobacco research cigarettes | Other | RC 1 only, RC 2 + EC 1, RC 2 + EC 2, RC 2 only |
| E-CigarettesAlso: e-cigarette with only tobacco flavor (EC 1); e-cigarette in multiple flavors ( EC2)Comparing effects of combining RC2 with EC 1 versus EC2 | Other | RC 2 + EC 1, RC 2 + EC 2 |
Primary outcome
Number of Cigarettes Smoked Per Day
Time frame: 16 weeks
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42560883Nolder KA, Erath TG, DeSarno MJ, Klemperer EM, Higgins ST. A further examination of the validity of assessing demand intensity using the Cigarette Purchase Task. Exp Clin Psychopharmacol. 2026 Aug 6:10.1037/pha0000874. doi: 10.1037/pha0000874. Online ahead of print.
- Derived from this study: PubMed 39240566Higgins ST, Sigmon SC, Tidey JW, Heil SH, Gaalema DE, Lee DC, DeSarno MJ, Klemperer EM, Menson KE, Cioe PA, Plucinski S, Wiley RC, Orr E. Reduced Nicotine Cigarettes and E-Cigarettes in High-Risk Populations: 3 Randomized Clinical Trials. JAMA Netw Open. 2024 Sep 3;7(9):e2431731. doi: 10.1001/jamanetworkopen.2024.31731.
- Individual participant dataSharing planned: Yes. de-identified data
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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.
Stephen T. Higgins, Ph.D. 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 study testing Varying the nicotine content of cigarettes and E-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 2 inclusion and 3 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 Mar 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 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?
Number of Cigarettes Smoked Per Day (time frame: 16 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 NCT04092387, which also lists 2 linked publications.
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 Mar 2025.