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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036114-06 | 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 |
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC 1 only | Experimental | Research cigarettes #1 |
|
| RC 2 only | Experimental | Research Cigarettes #2 |
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| RC 2 + EC 1 | Experimental | Research Cigarettes #2 plus E-cigarettes #1 |
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| RC 2 + EC 2 | Experimental | Research Cigarettes #2 plus E-cigarettes #2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varying the nicotine content of cigarettes | Other | 1) Altering the nicotine content of the tobacco research cigarettes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Per Day | Cigarettes per day will be assessed for use of cigarettes with different nicotine content. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be female.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen T. Higgins, Ph.D. | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| University of Vermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39240566 | Derived | Higgins 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. |
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de-identified data
Data will be made available once we have published the results of the parent trials and manuscripts based on secondary analyses of those data, which we anticipate taking approximately three years
request data for stated scientific purpose
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| ID | Title | Description |
|---|---|---|
| FG000 | RC 1 Only | Research cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes |
| FG001 | RC 2 Only | Research Cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes |
| FG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
| FG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RC 1 Only | Research cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes |
| BG001 | RC 2 Only | Research Cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research 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 | Number of Cigarettes Smoked Per Day | Cigarettes per day will be assessed for use of cigarettes with different nicotine content. | Participants who completed week 16 of study | Posted | Least Squares Mean | Standard Error | cigarettes per day | 16 weeks |
|
16 weeks
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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 | RC 1 Only | Research cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OASIS Score Increase | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen T. Higgins, PhD | University of Vermont | 802-735-6267 | stephen.higgins@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2023 | Mar 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2023 | Feb 20, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Randomized parallel groups research design.
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Double blind dosing of tobacco cigarette nicotine content levels.
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| E-Cigarettes | Other | Comparing effects of combining RC2 with EC 1 versus EC2 |
|
|
| Burlington |
| Vermont |
| 05401 |
| United States |
| BG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
| BG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Population | Count of Participants | Participants |
|
| Educational level | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Primarily smokes mentholated cigarettes | Count of Participants | Participants |
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| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes per day |
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| Urine cotinine level | Mean | Standard Deviation | ng/mL |
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| Breath CO level | Mean | Standard Deviation | ppm |
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| Age started smoking regularly | Mean | Standard Deviation | years |
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| FTND score | Fagerstrom Test for Nicotine Dependence: In scoring the Fagerstrom Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. Classification of dependence, based on total score: 0-2 Very low 3-4 Low 5 Moderate 6-7 High 8-10 Very high | Mean | Standard Deviation | scores on a scale |
|
| Used other tobacco products, past 30 days | Count of Participants | Participants |
|
| Used e-cigarettes, past 30 days | Count of Participants | Participants |
|
| OG002 |
| RC 2 + EC 1 |
Research Cigarettes #2 plus E-cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
| OG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 |
|
|
| 0 |
| 83 |
| 9 |
| 83 |
| 71 |
| 83 |
| EG001 | RC 2 Only | Research Cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes | 0 | 85 | 4 | 85 | 74 | 85 |
| EG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 | 1 | 74 | 4 | 74 | 62 | 74 |
| EG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2 | 0 | 84 | 2 | 84 | 72 | 84 |
| Esophageal perforation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Irritability | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
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| Pregnancy, puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | CTCAE (5.0) | Systematic Assessment |
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| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Renal calculi | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| Death NOS | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| BDI Category Increase | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| General disorders and administration | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Infections and infestations | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Vascular disorders | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Surgical and medical procedures | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D001519 |
| Behavior |