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| ID | Type | Description | Link |
|---|---|---|---|
| R03DA045197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.
Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.Smokers will be confined to a hotel for two hotel stays (five days/ four nights each) during which they will only have access to the investigational cigarettes provided to them. The nicotine content of the investigational cigarettes may differ between the two weeks. Participants will enter the hotel in groups of 10 and everyone in a given stay will receive the same investigational cigarette. The first aim will assess measures of smoke and nicotine exposure including urinary cotinine and expired carbon monoxide. The second aim will assess behavioral measures of smoking including cigarettes smoked per day and puff topography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Content Manipulation | Experimental | All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal nicotine content cigarettes (NNC, Baseline) | Other | Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel. |
| Measure | Description | Time Frame |
|---|---|---|
| Breath Sample (Expired Carbon Monoxide) | Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section. | 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5 |
| Average Cigarettes Smoked Per Day | Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section. | Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | Measure of withdrawal, Total Score is presented here, Range from 0-60 with higher scores indicating greater withdrawal. Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. Data from the NNC (Baseline) conditions are reported in the baseline section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Smith, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32102910 | Derived | Smith TT, Koopmeiners JS, White CM, Denlinger-Apte RL, Pacek LR, De Jesus VR, Wang L, Watson C, Blount BC, Hatsukami DK, Benowitz NL, Donny EC, Carpenter MJ. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2020 Apr;29(4):880-886. doi: 10.1158/1055-9965.EPI-19-0963. Epub 2020 Feb 26. |
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Participants were screened for eligibility prior to the baseline condition. Participants were then required to return to the lab on a designated date to complete an additional drug screen and begin the hotel phase. Participants could withdraw or be lost to follow up between screening and baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Very Low Nicotine Content | All participants receive normal nicotine content (NNC) cigarettes during baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is not an intent to treat trial. Baseline characteristics are reported only for those participants who were included in the final (analyzed) sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Content Manipulation | All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. During both the NNC and VLNC conditions, participants stay in a hotel and exclusively use the cigarettes provided to them. Each condition lasts four nights / five days. Baseline outcomes for the NNC condition are reported below, and VLNC condition outcomes are reported in the results section. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Breath Sample (Expired Carbon Monoxide) | Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section. | Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial. | Posted | Mean | Standard Deviation | parts per million | 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5 |
|
one month
Adverse Events were recorded either when spontaneously reported at any time during the hotel phase or when participants answered yes to the following question "Have you had any negative changes in your physical or mental health since you've been in the hotel that you think might be related to study participation?" This question was asked on Day 5 of both the NNC (baseline) and VLNC conditions. Events reported below may have been reported during either condition.
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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 | Nicotine Content Manipulation | All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. During both the NNC and VLNC conditions, participants stay in a hotel and exclusively use the cigarettes provided to them. Each condition lasts four nights / five days. Adverse events reported below may have been reported during either the NNC or VLNC condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracy Smith | Medical University of South Carolina | 843-792-5164 | smithtra@musc.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 | Jul 24, 2018 | Jan 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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All participants experienced an NNC phase (baseline) and a VLNC phase.
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| Very low nicotine content (VLNC) | Other | Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel. |
|
| Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. |
| Questionnaire of Smoking Urges | Measure of craving, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition. | Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition. |
| PI Withdrawal for Positive Drug Screen |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education: Some College or More | Count of Participants | Participants |
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| Usual cigarette brand is menthol | Count of Participants | Participants |
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| Self-reported cigarettes per day at screening | Mean | Full Range | cigarettes per day |
|
| Breath Sample (Expired Carbon Monoxide) | Measure of short term smoke exposure, higher readings indicate more smoke exposure, While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Data from the NNC (baseline) condition are reported here. | Mean | Standard Deviation | parts per million |
|
| Average cigarettes smoked per day | Average number of cigarettes smoked per day during the hotel phase. Participants collected cigarette butts and returned them at 12pm each day creating four 24-samples during both the NNC (baseline) and VLNC conditions. Data from the NNC (Baseline) Condition are reported here. | Mean | Standard Deviation | cigarettes per day |
|
| Minnesota Nicotine Withdrawal Scale | Minnesota Nicotine Withdrawal Scale, A measure of nicotine withdrawal. Presented here is the total score, which has a range of 0 to 60, with higher scores indicating more withdrawal. Participants complete a self-report questionnaire on Days 2-5 during the hotel phase of the NNC (baseline) and VLNC conditions. Data from the NNC (Baseline) Condition are reported here. | Mean | Standard Deviation | units on a scale |
|
| Questionnaire of Smoking Urges | Questionnaire of Smoking Urges, a Measure of craving, Presented here is Total Score, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and the VLNC conditions. Data from the NNC (baseline) condition are not reported here. | Mean | Standard Deviation | units on a scale |
|
|
|
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| Primary | Average Cigarettes Smoked Per Day | Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section. | Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial. | Posted | Mean | Standard Deviation | Cigarettes per day | Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition. |
|
|
|
|
| Secondary | Minnesota Nicotine Withdrawal Scale | Measure of withdrawal, Total Score is presented here, Range from 0-60 with higher scores indicating greater withdrawal. Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. Data from the NNC (Baseline) conditions are reported in the baseline section. | Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial. | Posted | Mean | Standard Deviation | units on a scale | Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. |
|
|
|
|
| Secondary | Questionnaire of Smoking Urges | Measure of craving, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition. | Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial. | Posted | Mean | Standard Deviation | units on a scale | Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition. |
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| 0 |
| 16 |
| 0 |
| 16 |
| 13 |
| 16 |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Angry/Irritable/Frustrated Mood | General disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Body Pain and Achiness | General disorders | Systematic Assessment |
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| Change in Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Sleep Disturbances | General disorders | Systematic Assessment |
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| Craving to Smoke | General disorders | Systematic Assessment |
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| Bowel Movement Irregularity | Gastrointestinal disorders | Systematic Assessment |
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| Depressed Mood/ Sad | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Allergic Reaction | General disorders | Systematic Assessment |
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| Body Numbness | General disorders | Systematic Assessment |
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| Bug Bites | General disorders | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| 4th 24-hr sample |
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Interaction p=0.23 |
| Title | Measurements |
|---|---|
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| Day 5 |
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Interaction p=0.95 |
| Title | Measurements |
|---|---|
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| Day 5 |
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Interaction p=0.94 |