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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036114-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Vermont | OTHER |
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While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences.
The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. 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 with current ADs will be recruited at Brown University and the University of Vermont.
Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be 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 condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study 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, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).
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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 (participants receive tobacco flavor only) |
|
| RC 2 + EC 2 | Experimental | Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g) | Other | 1) Altering the nicotine content of the tobacco research cigarette |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes 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
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer W Tidey, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | RC 1 Only | Research Cigarettes #1 Participants in this group were randomized to receive normal nicotine content cigarettes (15.8mg/g) only, and e-cigarettes were not available. This condition of the intervention applied to these participants throughout all timepoints of the study
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| FG001 | RC 2 Only | Research Cigarettes #2 Participants in this group were randomized to receive reduced nicotine content cigarettes (0.4mg/g) only, and e-cigarettes were not available. This condition of the intervention applied to these participants throughout all timepoints of the study
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| FG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only) Participants in this group were randomized to receive reduced nicotine content cigarettes (0.4mg/g) only, and tobacco flavor e-cigarettes only. This condition of the intervention applied to these participants throughout all timepoints of the study
|
| FG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) Participants in this group were randomized to receive reduced nicotine content cigarettes (0.4mg/g) only, and were given availability to a variety of flavors, and thus were able to select preferred flavor. This condition of the intervention applied to these participants throughout all timepoints of the study
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RC 1 Only | Research Cigarettes #1 Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette |
| BG001 | RC 2 Only |
| 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 | Cigarettes 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 Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette |
| 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 | |
|---|---|---|---|---|
| Jennifer W. Tidey | Brown University | 4018636418 | jennifer_tidey@brown.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 | Feb 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2023 | Feb 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D019964 | Mood Disorders |
| 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 levels.
| E-Cigarettes | Other | 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition |
|
| Burlington |
| Vermont |
| 05401 |
| United States |
Research Cigarettes #2
Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette
| BG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition |
| BG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Population | Count of Participants | Participants |
|
| Educational level | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
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| Primarily smokes mentholated cigarettes | Count of Participants | Participants |
|
| 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 |
|
| FTND total 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). Two of the three multiple-choice items are scored from 0 to 3, with the third multiple choice item being scored from 0 to 1. 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 (participants receive tobacco flavor only) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition |
| OG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition |
|
|
| 0 |
| 83 |
| 9 |
| 83 |
| 71 |
| 83 |
| EG001 | RC 2 Only | Research Cigarettes #2 Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette | 0 | 85 | 4 | 85 | 74 | 85 |
| EG002 | RC 2 + EC 1 | Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition | 1 | 74 | 4 | 74 | 62 | 74 |
| EG003 | RC 2 + EC 2 | Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g): 1) Altering the nicotine content of the tobacco research cigarette E-Cigarettes: 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition | 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 |
|
| 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 |
|
| 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 |