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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036114 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Food and Drug Administration (FDA) | FED |
| University of Kentucky | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low nicotine content cigarettes | Experimental |
| |
| Usual Brand | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low nicotine content cigarettes | Other | Cigarettes containing 0.4 mg nicotine/g tobacco |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cigarettes Per Day | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah H. Heil | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| University of Vermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40623557 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Very Low Nicotine Content Cigarettes | Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco |
| FG001 | Usual Brand | Participant's usual brand cigarettes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Very Low Nicotine Content Cigarettes | Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco |
| BG001 | Usual Brand | Participant's usual brand cigarettes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Cigarettes Per Day | Posted | Mean | Standard Error | Cigarettes per day | 12 weeks |
|
|
12-week intervention period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Very Low Nicotine Content Cigarettes | Cigarettes containing 0.4 mg nicotine/g tobacco |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Placenta previa | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
The sample included participants who smoke more than is typical during pregnancy and the sample size (N=30) was small. Study generality may be limited by the high smoking rate and the small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah H. Heil, PhD | University of Vermont | 802-656-8712 | Sarah.Heil@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2022 | May 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2024 | May 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Burlington |
| Vermont |
| 05401 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Gestational age at screening | Mean | Standard Deviation | Weeks |
|
| Cigarettes per day pre-pregnancy | Mean | Standard Deviation | Cigarettes per day |
|
| Cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 11 |
| 16 |
| EG001 | Usual Brand | Participant's usual brand cigarettes | 0 | 14 | 1 | 14 | 13 | 14 |
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorder and administration | General disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal and connective tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
|
| Pregnancy, puerperium and perinatal | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastina | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Breath carbon monoxide >50ppm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Breath carbon monoxide >100% baseline level | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cigarettes per day >/= 100% baseline level | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Beck Depression Inventory score | Psychiatric disorders | Systematic Assessment |
|
| Increased Overall Anxiety Severity and Impairment Scale score | Psychiatric disorders | Systematic Assessment |
|
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