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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA036107-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| George Washington University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.
Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Nicotine Content Cigarettes | Experimental | the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. |
|
| Same Nicotine Content Cigarettes | Placebo Comparator | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Nicotine Content Cigarettes | Drug | Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Dropped Out of Study as a Measure of Adherence | Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of Participant Dropout | Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Muscat, PhD | Penn State College of Medicine | Principal Investigator |
| Kimberly Horn, PhD | George Washington University School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University School of Public Health | Washington D.C. | District of Columbia | 20052 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28673312 | Derived | Krebs NM, Allen SI, Veldheer S, Martinez DJ, Horn K, Livelsberger C, Modesto J, Kuprewicz R, Wilhelm A, Hrabovsky S, Kazi A, Fazzi A, Liao J, Zhu J, Wasserman E, Reilly SM, Reinhart L, Trushin N, Moyer RE, Bascom R, Foulds J, Richie JP Jr, Muscat JE. Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Trials. 2017 Jul 3;18(1):300. doi: 10.1186/s13063-017-2038-9. |
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Participants completed a baseline phase of one week on usual brand cigarettes and another baseline phase on same nicotine content cigarettes (2 weeks). Of these, 35 participants either were lost to follow up or withdrawn from the study during the baseline phase and before they started the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Nicotine Content Cigarettes | The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette |
| FG001 | Same Nicotine Content Cigarettes | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline values for outcomes reflect levels after participants were on the usual nicotine content cigarettes for 2 weeks and before they received the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Nicotine Content Cigarettes | The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette |
| 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 Participants Who Dropped Out of Study as a Measure of Adherence | Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization. | All randomized participants | Posted | Count of Participants | Participants | 18 weeks |
|
33 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their physical or mental health or if they needed to seek immediate medical care at an emergency room or hospital.
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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 | Reduced Nicotine Content Cigarettes | The experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Reduced Nicotine Content Cigarettes: Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
The sample size was not reached due to a shortage of study cigarette inventory.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolle Krebs | Penn State College of Medicine | 717-531-5673 | nkrebs@pennstatehealth.psu.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 | Mar 19, 2019 | Apr 10, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Same Nicotine Content Cigarettes | Drug | about 11.6 mg nicotine per cigarette |
|
|
| Cigarettes Per Day |
Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back |
| 18 weeks |
| Nicotine Exposure | Measured by cotinine (ng/ml) measured in plasma | 18 weeks |
| Smoke Exposure | Measured in carbon monoxide levels by expired CO | 18 weeks |
| Perceived Stress | Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress. | 18 weeks |
| Cortisol | Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used. | 15 weeks |
| Penn State College of Medicine |
| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| Protocol Violation |
|
| Adverse Event |
|
| BG001 | Same Nicotine Content Cigarettes | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Cigarettes per Day | Mean | Standard Deviation | cigarettes |
|
| Plasma Cotinine | Samples below the level of detection were set to 3 ng/mL. | Mean | Standard Deviation | ng/ml |
|
| Exhaled Carbon Monoxide | Mean | Standard Deviation | parts per million |
|
| Perceived Stress Scale Score | 10-item version was used. Scale range is 0-40. Higher scores indicate more stress. | Mean | Standard Deviation | units on a scale |
|
| Menthol smoker | Count of Participants | Participants |
|
| OG001 | Same Nicotine Content Cigarettes | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette |
|
|
|
| Secondary | Predictors of Participant Dropout | Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome. | Participants (who were randomized) are stratified according to the listed characteristics. | Posted | Count of Participants | Participants | 18 weeks |
|
|
|
|
| Secondary | Cigarettes Per Day | Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back | All randomized participants | Posted | Least Squares Mean | 95% Confidence Interval | cigarettes per day | 18 weeks |
|
|
|
|
| Secondary | Nicotine Exposure | Measured by cotinine (ng/ml) measured in plasma | All randomized participants | Posted | Least Squares Mean | 95% Confidence Interval | ng/ml | 18 weeks |
|
|
|
|
| Secondary | Smoke Exposure | Measured in carbon monoxide levels by expired CO | All randomized participants | Posted | Least Squares Mean | 95% Confidence Interval | parts per million (ppm) | 18 weeks |
|
|
|
|
| Secondary | Perceived Stress | Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress. | All randomized participants | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 18 weeks |
|
|
|
|
| Secondary | Cortisol | Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used. | A subset of participants was randomly selected to complete the cortisol collection procedure and those who provided usable samples 1-3 were used in this analysis | Posted | Least Squares Mean | 95% Confidence Interval | ng/dl | 15 weeks |
|
|
|
|
| 1 |
| 122 |
| 11 |
| 122 |
| 54 |
| 122 |
| EG001 | Same Nicotine Content Cigarettes | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) Same Nicotine Content Cigarettes: about 11.6 mg nicotine per cigarette | 1 | 123 | 11 | 123 | 63 | 123 |
| Anal fistula | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment | Hernia |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment | Diabetes |
|
| Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Psychiatric disorders - Other | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment | Psychiatric hospitalization |
|
| Reproductive system and breast disorders - Other | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment | Breast cancer diagnosis |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Respiratory, thoracic, and mediastinal disorders- Other | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
|
| Age group 18-29 |
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| Age group 30-39 |
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| Age group 40-49 |
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| Age group 50-59 |
|
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| Age group 60-65 |
|
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| Not currently working |
|
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| Currently working |
|
|
| BMI Underweight (<18.5) |
|
|
| BMI Normal weight (>=18.5 and <25) |
|
|
| BMI Overweight (>=25 and <30) |
|
|
| BMI Obese (>=30) |
|
|
| The reference group is Age equals 18-29. | Regression, Cox | Adjusting for Treatment Group, Working Status, and BMI. | 0.06 | Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.51 | 2-Sided | 95 | 0.26 | 1.03 | The direction of comparison is Age group 30-39 to the Age group 18-29. | Other |
| The reference group is Age equals 18-29. | Regression, Cox | Adjusting for Treatment Group, Working Status, and BMI. | <0.002 | Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.33 | 2-Sided | 95 | 0.17 | 0.66 | The direction of comparison is Age group 40-49 to the Age group 18-29. | Other |
| The reference group is Age equals 18-29. | Regression, Cox | Adjusting for Treatment Group, Working Status, and BMI. | <0.002 | Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.33 | 2-Sided | 95 | 0.16 | 0.65 | The direction of comparison is Age group 50-59 to Age group 18-29. | Other |
| The reference group is Age equals 18-29. | Regression, Cox | Adjusting for Treatment Group, Working Status, and BMI. | 0.1 | Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.39 | 2-Sided | 95 | 0.13 | 1.18 | The direction of comparison is Age group 60-65 to the Age group 18-29. | Other |
| The reference group is not currently working. | Regression, Cox | Adjusting for Treatment Group, Age, and BMI. | 0.1 | Testing the effect of working status in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 1.6 | 2-Sided | 95 | 0.92 | 2.66 | Other | The direction of comparison is currently working to not currently working. |
| The reference group is BMI Underweight (<18.5) | Regression, Cox | Adjusting for Treatment Group, Working Status, and Age. | 0.006 | Testing the effect of BMI Normal Weight group (>=18.5 & <25) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.25 | 2-Sided | 95 | 0.1 | 0.67 | The direction of comparison is Normal Weight (>=18.5 & <25) to Underweight (<18.5) group. | Other |
| The reference group is BMI Underweight group (<18.5) | Regression, Cox | Adjusting for Treatment Group, Working Status, and Age. | 0.034 | Testing the effect of BMI Overweight group (>=25 & < 30) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.35 | 2-Sided | 95 | 0.13 | 0.92 | The direction of comparison is Overweight (>=25 & < 30) to Underweight (<18.5) group. | Other |
| The reference group is BMI Underweight group (<18.5) | Regression, Cox | Adjusting for Treatment Group, Working Status, and Age. | 0.011 | Testing the effect of BMI Obese group (>=30) in a Multivariable Cox Regression Model. | Hazard Ratio (HR) | 0.31 | 2-Sided | 95 | 0.13 | 0.77 | The direction of comparison is Obese (>=30) to Underweight (<18.5) group. | Other |