Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.
The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low nicotine content cigarettes | Experimental |
| |
| Normal nicotine content cigarettes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low nicotine content cigarettes | Drug | 0.07 mg nicotine delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cigarette Consumption | Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data | Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure Measure - Solanesol | The concentration of solanesol, a stable marker indicator of how much smoke has passed through the filter of a smoked cigarette to the smoker, will be assayed as a measure of smoking intensity. The filter of a cigarette butts smoked during the baseline period will be compared to those smoked during the experimental period. | Post-randomization time points at study weeks 4, 8, 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saul Shiffman, PhD | University of Pittsburgh, Department of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smoking Research Group, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29902305 | Derived | Shiffman S, Kurland BF, Scholl SM, Mao JM. Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):995-1002. doi: 10.1001/jamapsychiatry.2018.1831. |
Not provided
Not provided
Participants may have been excluded from the study after enrollment but before assignment to an arm if they were found to be unable to adhere to the study protocol or were unable to attend study visits, opted to no longer participate, or if they became unable to contact (i.e., were lost to follow-up).
Participants were recruited from the greater Pittsburgh area from June 2015 through April 2017 via various channels (e.g., advertisements on local television stations, public transportation, and social media such as Facebook and Instagram), as well as through University-housed research registries and recruiting services.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Very Low Nicotine Content Cigarettes | Very low nicotine content cigarettes: 0.07 mg nicotine delivery |
| FG001 | Normal Nicotine Content Cigarettes | Normal nicotine content cigarettes: 0.8 mg nicotine delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Very Low Nicotine Content Cigarettes | Very low nicotine content cigarettes: 0.07 mg nicotine delivery |
| BG001 | Normal Nicotine Content Cigarettes | Normal nicotine content cigarettes: 0.8 mg nicotine delivery |
| 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 | Change in Cigarette Consumption | Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data | All participants who were randomized to an experimental condition (either very-low-nicotine-content cigarettes or normal-nicotine-content cigarettes) | Posted | Least Squares Mean | 95% Confidence Interval | cigarettes per day | Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period |
|
Adverse event data was collected for each participant during the time of enrollment to completion of the study. Enrollment of study participants began in June 2015 and data collection concluded in July 2017. Thus, adverse event data for the entire study was collected over a 26 month span. Each individual participant participated in the study for 12 weeks.
Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended form, as well as via the self-completed Respiratory Health Questionnaire administered to participants at study visits.
Not provided
| 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 | Very low nicotine content cigarettes: 0.07 mg nicotine delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for acute change in mental status (tranisient, unknown etiology) | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory (cough, cold) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Saul Shiffman | University of Pittsburgh | 412-567-1761 | shiffman@pinneyassociates.com |
Not provided
| 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 | May 7, 2018 | Jul 26, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal nicotine content cigarettes | Drug | 0.8 mg nicotine delivery |
|
| Exposure Measure - Smoking Topography | Difference between average puff volume per cigarette at laboratory smoking topography sessions at study weeks 4, 8, and 12 across all participants, comparing those assigned to the very-low-nicotine-content cigarette condition to those assigned to the normal-nicotine-content cigarette condition. Topography measures were averaged across all time points for each treatment group. | Post-randomization study visits at study weeks 4, 8, 12 |
| Exposure Measure - Cotinine (Logged) | Cotinine nicotine exposure measure, analyzed from urine samples taken at study office visits The natural logarithm (ln) of the cotinine measures was used for analysis. Difference in ln(cotinine) between baseline and end of study, from imputed data | Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study) |
| Exposure Measure - Cigarette Butt Weight | Mean mass smoked per cigarette (calculated as the starting cigarette weight minus returned butt weight) aggregated for all cigarettes smoked among participants assigned to the very-low-nicotine-content cigarette, compared to those assigned to the normal-nicotine-content cigarette condition. | Entire length of study, through completion, up to 12 weeks |
| BG002 | 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 |
|
| Cigarettes per day at enrollment (across all days) | Average cigarettes per day, across all calendar days in the month preceding initial visit, reported via calendar-based TimeLine Follow-Back | Mean | Standard Deviation | cigarettes per day |
|
| Smoking days per week at enrollment | Average smoking days per week, across all calendar days in the month preceding initial visit, reported via calendar-based TimeLine Follow-Back | Mean | Standard Deviation | smoking days per week |
|
| Cigarettes per day at enrollment (smoking days only) | Average cigarettes per day (across smoking days only) in the month preceding initial visit, reported via calendar-based TimeLine Follow-Back | Mean | Standard Deviation | cigarettes per day |
|
| Previous history of daily smoking | Those participants who reported having previously smoked daily, continuously for at least six months, were classified as past daily smokers | Count of Participants | Participants |
|
Normal nicotine content cigarettes: 0.8 mg nicotine delivery
|
|
|
| Secondary | Exposure Measure - Solanesol | The concentration of solanesol, a stable marker indicator of how much smoke has passed through the filter of a smoked cigarette to the smoker, will be assayed as a measure of smoking intensity. The filter of a cigarette butts smoked during the baseline period will be compared to those smoked during the experimental period. | Posted | Least Squares Mean | Standard Error | mg/butt | Post-randomization time points at study weeks 4, 8, 12 |
|
|
|
| Secondary | Exposure Measure - Smoking Topography | Difference between average puff volume per cigarette at laboratory smoking topography sessions at study weeks 4, 8, and 12 across all participants, comparing those assigned to the very-low-nicotine-content cigarette condition to those assigned to the normal-nicotine-content cigarette condition. Topography measures were averaged across all time points for each treatment group. | Analysis consists of those participants who contributed data to the study through at least study week 4. | Posted | Least Squares Mean | Standard Error | mL | Post-randomization study visits at study weeks 4, 8, 12 |
|
|
|
|
| Secondary | Exposure Measure - Cotinine (Logged) | Cotinine nicotine exposure measure, analyzed from urine samples taken at study office visits The natural logarithm (ln) of the cotinine measures was used for analysis. Difference in ln(cotinine) between baseline and end of study, from imputed data | Posted | Mean | 95% Confidence Interval | log ng/mL | Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study) |
|
|
|
|
| Secondary | Exposure Measure - Cigarette Butt Weight | Mean mass smoked per cigarette (calculated as the starting cigarette weight minus returned butt weight) aggregated for all cigarettes smoked among participants assigned to the very-low-nicotine-content cigarette, compared to those assigned to the normal-nicotine-content cigarette condition. | Analysis population consists of those participants who contributed data to the study for (at minimum) the two-week baseline study period block as well as the first two-week block post-randomization | Posted | Least Squares Mean | Standard Error | grams | Entire length of study, through completion, up to 12 weeks |
|
|
|
|
| 0 |
| 118 |
| 1 |
| 118 |
| 41 |
| 118 |
| EG001 | Normal Nicotine Content Cigarettes | Normal nicotine content cigarettes: 0.8 mg nicotine delivery | 0 | 120 | 2 | 120 | 42 | 120 |
| Hospitalization for mini-seizures | Nervous system disorders | Systematic Assessment |
|
| Hospitalization for psychiatric medication management | Psychiatric disorders | Systematic Assessment |
|
| Nausea / flu | Gastrointestinal disorders | Systematic Assessment |
|
| Seasonal allergies | Immune system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided