A Phase 1/2 interventional study of Very low nicotine content cigarettes in Tobacco Use Disorder, sponsored by University of Vermont. Completed at 2 sites in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Vermont · Phase 1/2, Interventional, and Basic science
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.
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Very low nicotine content cigarettes
Cigarettes containing 0.4 mg nicotine/g tobacco
Total Cigarettes Per Day
Time frame: 12 weeks
| Milestone | Very Low Nicotine Content Cigarettes | Usual Brand |
|---|---|---|
| Started | 16 | 14 |
| Completed | 12 | 11 |
| Not completed | 4 | 3 |
| Cigarettes per day | Very Low Nicotine Content Cigarettes | Usual Brand |
|---|---|---|
| Total Cigarettes Per Day | 16.31 ± 2.63 | 18.36 ± 2.32 |
Collected over 12-week intervention period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Very Low Nicotine Content Cigarettes | 0/16 (0%) | 0/16 (0%) | 11/16 (68.8%) |
| Usual Brand | 0/14 (0%) | 1/14 (7.1%) | 13/14 (92.9%) |
| Event | Very Low Nicotine Content Cigarettes | Usual Brand |
|---|---|---|
| Placenta previaPregnancy, puerperium and perinatal conditions | 0/16 | 1/14 |
| Event | Very Low Nicotine Content Cigarettes | Usual Brand |
|---|---|---|
| Increased Beck Depression Inventory scorePsychiatric disorders | 7/16 | 7/14 |
| Increased Overall Anxiety Severity and Impairment Scale scorePsychiatric disorders | 4/16 | 5/14 |
| Gastrointestinal disordersGastrointestinal disorders | 4/16 | 2/14 |
| Infections and infestationsInfections and infestations | 4/16 | 2/14 |
| Musculoskeletal and connective tissueMusculoskeletal and connective tissue disorders | 1/16 | 3/14 |
| Pregnancy, puerperium and perinatalPregnancy, puerperium and perinatal conditions | 1/16 | 3/14 |
| General disorder and administrationGeneral disorders | 3/16 | 0/14 |
| Psychiatric disordersPsychiatric disorders | 2/16 | 2/14 |
| Vascular disordersVascular disorders | 2/16 | 2/14 |
| Cardiac disordersCardiac disorders | 2/16 | 0/14 |
| Age, Continuous(Years) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Mean | 28.31 ± 4.80 | 27.57 ± 4.77 | 27.97 ± 4.72 |
| Sex: Female, Male(Participants) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Female | 16 | 14 | 30 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Non-Latino White | 15 | 14 | 29 |
| Non-Latino other | 1 | 0 | 1 |
| Gestational age at screening(Weeks) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Mean | 11.94 ± 4.99 | 13.43 ± 6.26 | 12.63 ± 5.57 |
| Cigarettes per day pre-pregnancy(Cigarettes per day) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Mean | 18.38 ± 5.91 | 23.93 ± 14.08 | 20.97 ± 10.72 |
| Cigarettes per day(Cigarettes per day) | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Mean | 19.19 ± 8.15 | 16.21 ± 8.05 | 17.80 ± 8.10 |
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