Smoking
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNormal nicotine content cigarettes (NNC, Baseline)
Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel.
OTHERVery low nicotine content (VLNC)
Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel.
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants experienced an NNC phase (baseline) and a VLNC phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male or female participants who are least 18 years old and smoke daily * willing to stay in a hotel for two four-night stays during the prearranged dates
Exclusion criteria
* unwilling to use research cigarettes as part of the trial * pregnant, trying to become pregnant, or breastfeeding * additional smoking and health criteria determined at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath Sample (Expired Carbon Monoxide) | 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5 | 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. |
| Average Cigarettes Smoked 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Nicotine Withdrawal 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. | 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. |
| Questionnaire of Smoking Urges | 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | PI Withdrawal for Positive Drug Screen | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Nicotine Content Manipulation |
|---|---|
| Age, Continuous | 38.87 years |
| Average cigarettes smoked per day 1st 24-hr sample | 17.69 cigarettes per day STANDARD_DEVIATION 8.26 |
| Average cigarettes smoked per day 2nd 24-hr sample | 19.13 cigarettes per day STANDARD_DEVIATION 7.87 |
| Average cigarettes smoked per day 3rd 24-hr sample | 19.13 cigarettes per day STANDARD_DEVIATION 9.01 |
| Average cigarettes smoked per day 4th 24-hr sample | 21.88 cigarettes per day STANDARD_DEVIATION 9.13 |
| Breath Sample (Expired Carbon Monoxide) Day 1 (4pm) | 17.16 parts per million STANDARD_DEVIATION 6.95 |
| Breath Sample (Expired Carbon Monoxide) Day 1 (8pm) | 31.26 parts per million STANDARD_DEVIATION 15.26 |
| Breath Sample (Expired Carbon Monoxide) Day 2 (12pm) | 32.16 parts per million STANDARD_DEVIATION 16.32 |
| Breath Sample (Expired Carbon Monoxide) Day 2 (4pm) | 32.78 parts per million STANDARD_DEVIATION 16.87 |
| Breath Sample (Expired Carbon Monoxide) Day 2 (8am) | 23.97 parts per million STANDARD_DEVIATION 12.15 |
| Breath Sample (Expired Carbon Monoxide) Day 2 (8pm) | 32.74 parts per million STANDARD_DEVIATION 16.87 |
| Breath Sample (Expired Carbon Monoxide) Day 3 (12pm) | 30.30 parts per million STANDARD_DEVIATION 16.31 |
| Breath Sample (Expired Carbon Monoxide) Day 3 (4pm) | 29.06 parts per million STANDARD_DEVIATION 16.83 |
| Breath Sample (Expired Carbon Monoxide) Day 3 (8am) | 24.60 parts per million STANDARD_DEVIATION 10.16 |
| Breath Sample (Expired Carbon Monoxide) Day 3 (8pm) | 30.72 parts per million STANDARD_DEVIATION 15.61 |
| Breath Sample (Expired Carbon Monoxide) Day 4 (12pm) | 30.38 parts per million STANDARD_DEVIATION 16.74 |
| Breath Sample (Expired Carbon Monoxide) Day 4 (4pm) | 31.61 parts per million STANDARD_DEVIATION 18.16 |
| Breath Sample (Expired Carbon Monoxide) Day 4 (8am) | 21.94 parts per million STANDARD_DEVIATION 11.74 |
| Breath Sample (Expired Carbon Monoxide) Day 4 (8pm) | 32.09 parts per million STANDARD_DEVIATION 17.65 |
| Breath Sample (Expired Carbon Monoxide) Day 5 (12pm) | 33.95 parts per million STANDARD_DEVIATION 17.11 |
| Breath Sample (Expired Carbon Monoxide) Day 5 (8am) | 26.39 parts per million STANDARD_DEVIATION 14.19 |
| Education: Some College or More | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Minnesota Nicotine Withdrawal Scale Day 2 | 20.44 units on a scale STANDARD_DEVIATION 4.46 |
| Minnesota Nicotine Withdrawal Scale Day 3 | 21.13 units on a scale STANDARD_DEVIATION 5.02 |
| Minnesota Nicotine Withdrawal Scale Day 4 | 21.13 units on a scale STANDARD_DEVIATION 4.47 |
| Minnesota Nicotine Withdrawal Scale Day 5 | 21.38 units on a scale STANDARD_DEVIATION 4.56 |
| Questionnaire of Smoking Urges Day 2 | 19.25 units on a scale STANDARD_DEVIATION 10.5 |
| Questionnaire of Smoking Urges Day 3 | 22.06 units on a scale STANDARD_DEVIATION 12.13 |
| Questionnaire of Smoking Urges Day 4 | 18.94 units on a scale STANDARD_DEVIATION 12.91 |
| Questionnaire of Smoking Urges Day 5 | 19.00 units on a scale STANDARD_DEVIATION 10.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 participants |
| Self-reported cigarettes per day at screening | 14.75 cigarettes per day |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
| Usual cigarette brand is menthol | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 13 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: 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.
Population: Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Very Low Nicotine Content | Average Cigarettes Smoked Per Day | 1st 24-hr sample | 19.13 Cigarettes per day | Standard Deviation 11.99 |
| Very Low Nicotine Content | Average Cigarettes Smoked Per Day | 2nd 24-hr sample | 22.38 Cigarettes per day | Standard Deviation 14.69 |
| Very Low Nicotine Content | Average Cigarettes Smoked Per Day | 3rd 24-hr sample | 20.13 Cigarettes per day | Standard Deviation 13.11 |
| Very Low Nicotine Content | Average Cigarettes Smoked Per Day | 4th 24-hr sample | 20.69 Cigarettes per day | Standard Deviation 13.31 |
Comparison: Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.p-value: 0.1595% CI: [-0.41, 2.66]Mixed Models Analysis
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.
Time frame: 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5
Population: Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 1 (4pm) | 18.77 parts per million | Standard Deviation 8.12 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 1 (8pm) | 31.07 parts per million | Standard Deviation 18.74 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 2 (8am) | 25.38 parts per million | Standard Deviation 14.51 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 2 (12pm) | 30.49 parts per million | Standard Deviation 16.04 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 2 (4pm) | 36.72 parts per million | Standard Deviation 24.68 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 2 (8pm) | 35.66 parts per million | Standard Deviation 18.79 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 3 (8am) | 26.06 parts per million | Standard Deviation 13.62 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 3 (12pm) | 31.65 parts per million | Standard Deviation 18.59 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 3 (4pm) | 31.90 parts per million | Standard Deviation 17.47 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 3 (8pm) | 34.14 parts per million | Standard Deviation 17.81 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 4 (8am) | 23.27 parts per million | Standard Deviation 14.28 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 4 (12pm) | 24.82 parts per million | Standard Deviation 14.09 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 4 (4pm) | 28.99 parts per million | Standard Deviation 16.03 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 4 (8pm) | 30.03 parts per million | Standard Deviation 17.25 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 5 (8am) | 22.22 parts per million | Standard Deviation 13.18 |
| Very Low Nicotine Content | Breath Sample (Expired Carbon Monoxide) | Day 5 (12pm) | 30.99 parts per million | Standard Deviation 17.07 |
Comparison: Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.p-value: 0.9295% CI: [-1.27, 1.4]Mixed Models Analysis
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.
Time frame: 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.
Population: Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Very Low Nicotine Content | Minnesota Nicotine Withdrawal Scale | Day 2 | 23.94 units on a scale | Standard Deviation 8.39 |
| Very Low Nicotine Content | Minnesota Nicotine Withdrawal Scale | Day 3 | 24.19 units on a scale | Standard Deviation 7.02 |
| Very Low Nicotine Content | Minnesota Nicotine Withdrawal Scale | Day 4 | 23.69 units on a scale | Standard Deviation 7.51 |
| Very Low Nicotine Content | Minnesota Nicotine Withdrawal Scale | Day 5 | 25.00 units on a scale | Standard Deviation 9.36 |
Comparison: Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.p-value: <0.00195% CI: [1.77, 4.6]Mixed Models Analysis
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.
Time frame: 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.
Population: Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Very Low Nicotine Content | Questionnaire of Smoking Urges | Day 2 | 19.94 units on a scale | Standard Deviation 10.95 |
| Very Low Nicotine Content | Questionnaire of Smoking Urges | Day 3 | 21.31 units on a scale | Standard Deviation 14.47 |
| Very Low Nicotine Content | Questionnaire of Smoking Urges | Day 4 | 20.00 units on a scale | Standard Deviation 14.32 |
| Very Low Nicotine Content | Questionnaire of Smoking Urges | Day 5 | 18.94 units on a scale | Standard Deviation 11.86 |
Comparison: Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.p-value: 0.8495% CI: [-2, 2.5]Mixed Models Analysis