Trial Outcomes & Findings for Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking (NCT NCT03311646)
NCT ID: NCT03311646
Last Updated: 2020-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5
Results posted on
2020-01-28
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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15
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Physician Decision
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1
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Overall Study
Withdrawal by Subject
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5
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Overall Study
Lost to Follow-up
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5
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Overall Study
PI Withdrawal for Positive Drug Screen
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4
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Baseline Characteristics
Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Baseline characteristics by cohort
| Measure |
Nicotine Content Manipulation
n=16 Participants
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.
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|---|---|
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Age, Continuous
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38.87 years
n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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14 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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Education: Some College or More
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8 Participants
n=5 Participants
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Usual cigarette brand is menthol
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7 Participants
n=5 Participants
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Self-reported cigarettes per day at screening
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14.75 cigarettes per day
n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 1 (4pm)
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17.16 parts per million
STANDARD_DEVIATION 6.95 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 1 (8pm)
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31.26 parts per million
STANDARD_DEVIATION 15.26 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 2 (8am)
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23.97 parts per million
STANDARD_DEVIATION 12.15 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 2 (12pm)
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32.16 parts per million
STANDARD_DEVIATION 16.32 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 2 (4pm)
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32.78 parts per million
STANDARD_DEVIATION 16.87 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 2 (8pm)
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32.74 parts per million
STANDARD_DEVIATION 16.87 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 3 (8am)
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24.60 parts per million
STANDARD_DEVIATION 10.16 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 3 (12pm)
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30.30 parts per million
STANDARD_DEVIATION 16.31 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 3 (4pm)
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29.06 parts per million
STANDARD_DEVIATION 16.83 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 3 (8pm)
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30.72 parts per million
STANDARD_DEVIATION 15.61 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 4 (8am)
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21.94 parts per million
STANDARD_DEVIATION 11.74 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 4 (12pm)
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30.38 parts per million
STANDARD_DEVIATION 16.74 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 4 (4pm)
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31.61 parts per million
STANDARD_DEVIATION 18.16 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 4 (8pm)
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32.09 parts per million
STANDARD_DEVIATION 17.65 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 5 (8am)
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26.39 parts per million
STANDARD_DEVIATION 14.19 • n=5 Participants
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Breath Sample (Expired Carbon Monoxide)
Day 5 (12pm)
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33.95 parts per million
STANDARD_DEVIATION 17.11 • n=5 Participants
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Average cigarettes smoked per day
1st 24-hr sample
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17.69 cigarettes per day
STANDARD_DEVIATION 8.26 • n=5 Participants
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Average cigarettes smoked per day
2nd 24-hr sample
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19.13 cigarettes per day
STANDARD_DEVIATION 7.87 • n=5 Participants
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Average cigarettes smoked per day
3rd 24-hr sample
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19.13 cigarettes per day
STANDARD_DEVIATION 9.01 • n=5 Participants
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Average cigarettes smoked per day
4th 24-hr sample
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21.88 cigarettes per day
STANDARD_DEVIATION 9.13 • n=5 Participants
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Minnesota Nicotine Withdrawal Scale
Day 2
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20.44 units on a scale
STANDARD_DEVIATION 4.46 • n=5 Participants
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Minnesota Nicotine Withdrawal Scale
Day 3
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21.13 units on a scale
STANDARD_DEVIATION 5.02 • n=5 Participants
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Minnesota Nicotine Withdrawal Scale
Day 4
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21.13 units on a scale
STANDARD_DEVIATION 4.47 • n=5 Participants
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Minnesota Nicotine Withdrawal Scale
Day 5
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21.38 units on a scale
STANDARD_DEVIATION 4.56 • n=5 Participants
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Questionnaire of Smoking Urges
Day 2
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19.25 units on a scale
STANDARD_DEVIATION 10.50 • n=5 Participants
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Questionnaire of Smoking Urges
Day 3
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22.06 units on a scale
STANDARD_DEVIATION 12.13 • n=5 Participants
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Questionnaire of Smoking Urges
Day 4
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18.94 units on a scale
STANDARD_DEVIATION 12.91 • n=5 Participants
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Questionnaire of Smoking Urges
Day 5
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19.00 units on a scale
STANDARD_DEVIATION 10.58 • n=5 Participants
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PRIMARY outcome
Timeframe: 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5Population: Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.
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.
Outcome measures
| Measure |
Very Low Nicotine Content
n=16 Participants
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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Breath Sample (Expired Carbon Monoxide)
Day 1 (4pm)
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18.77 parts per million
Standard Deviation 8.12
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Breath Sample (Expired Carbon Monoxide)
Day 1 (8pm)
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31.07 parts per million
Standard Deviation 18.74
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Breath Sample (Expired Carbon Monoxide)
Day 2 (8am)
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25.38 parts per million
Standard Deviation 14.51
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Breath Sample (Expired Carbon Monoxide)
Day 2 (12pm)
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30.49 parts per million
Standard Deviation 16.04
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Breath Sample (Expired Carbon Monoxide)
Day 2 (4pm)
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36.72 parts per million
Standard Deviation 24.68
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Breath Sample (Expired Carbon Monoxide)
Day 2 (8pm)
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35.66 parts per million
Standard Deviation 18.79
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Breath Sample (Expired Carbon Monoxide)
Day 3 (8am)
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26.06 parts per million
Standard Deviation 13.62
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Breath Sample (Expired Carbon Monoxide)
Day 3 (12pm)
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31.65 parts per million
Standard Deviation 18.59
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Breath Sample (Expired Carbon Monoxide)
Day 3 (4pm)
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31.90 parts per million
Standard Deviation 17.47
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Breath Sample (Expired Carbon Monoxide)
Day 3 (8pm)
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34.14 parts per million
Standard Deviation 17.81
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Breath Sample (Expired Carbon Monoxide)
Day 4 (8am)
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23.27 parts per million
Standard Deviation 14.28
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Breath Sample (Expired Carbon Monoxide)
Day 4 (12pm)
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24.82 parts per million
Standard Deviation 14.09
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Breath Sample (Expired Carbon Monoxide)
Day 4 (4pm)
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28.99 parts per million
Standard Deviation 16.03
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Breath Sample (Expired Carbon Monoxide)
Day 4 (8pm)
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30.03 parts per million
Standard Deviation 17.25
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Breath Sample (Expired Carbon Monoxide)
Day 5 (8am)
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22.22 parts per million
Standard Deviation 13.18
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Breath Sample (Expired Carbon Monoxide)
Day 5 (12pm)
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30.99 parts per million
Standard Deviation 17.07
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Very Low Nicotine Content
n=16 Participants
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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Average Cigarettes Smoked Per Day
1st 24-hr sample
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19.13 Cigarettes per day
Standard Deviation 11.99
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Average Cigarettes Smoked Per Day
2nd 24-hr sample
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22.38 Cigarettes per day
Standard Deviation 14.69
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Average Cigarettes Smoked Per Day
3rd 24-hr sample
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20.13 Cigarettes per day
Standard Deviation 13.11
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Average Cigarettes Smoked Per Day
4th 24-hr sample
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20.69 Cigarettes per day
Standard Deviation 13.31
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Very Low Nicotine Content
n=16 Participants
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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Minnesota Nicotine Withdrawal Scale
Day 4
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23.69 units on a scale
Standard Deviation 7.51
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Minnesota Nicotine Withdrawal Scale
Day 5
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25.00 units on a scale
Standard Deviation 9.36
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Minnesota Nicotine Withdrawal Scale
Day 2
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23.94 units on a scale
Standard Deviation 8.39
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Minnesota Nicotine Withdrawal Scale
Day 3
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24.19 units on a scale
Standard Deviation 7.02
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Very Low Nicotine Content
n=16 Participants
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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|---|---|
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Questionnaire of Smoking Urges
Day 2
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19.94 units on a scale
Standard Deviation 10.95
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Questionnaire of Smoking Urges
Day 3
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21.31 units on a scale
Standard Deviation 14.47
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Questionnaire of Smoking Urges
Day 4
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20.00 units on a scale
Standard Deviation 14.32
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Questionnaire of Smoking Urges
Day 5
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18.94 units on a scale
Standard Deviation 11.86
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Adverse Events
Nicotine Content Manipulation
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Content Manipulation
n=16 participants at risk
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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Respiratory, thoracic and mediastinal disorders
Cough
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18.8%
3/16 • 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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Respiratory, thoracic and mediastinal disorders
Sore Throat
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18.8%
3/16 • 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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General disorders
Angry/Irritable/Frustrated Mood
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12.5%
2/16 • 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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Gastrointestinal disorders
Heartburn
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12.5%
2/16 • 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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Respiratory, thoracic and mediastinal disorders
Shortness of Breath
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12.5%
2/16 • 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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General disorders
Headache
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12.5%
2/16 • 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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General disorders
Body Pain and Achiness
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12.5%
2/16 • 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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Metabolism and nutrition disorders
Change in Appetite
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6.2%
1/16 • 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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General disorders
Sleep Disturbances
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6.2%
1/16 • 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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General disorders
Craving to Smoke
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6.2%
1/16 • 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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Gastrointestinal disorders
Bowel Movement Irregularity
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6.2%
1/16 • 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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General disorders
Depressed Mood/ Sad
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6.2%
1/16 • 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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Gastrointestinal disorders
Nausea
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6.2%
1/16 • 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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General disorders
Allergic Reaction
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6.2%
1/16 • 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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General disorders
Body Numbness
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6.2%
1/16 • 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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General disorders
Bug Bites
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6.2%
1/16 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place