Trial Outcomes & Findings for Evaluating New Nicotine Standards for Cigarettes - Project 3 (NCT NCT03194256)
NCT ID: NCT03194256
Last Updated: 2023-12-18
Results Overview
The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
30-minute preference task
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
Normal Nicotine Content Cigarettes
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
Laboratory Session 2
|
41
|
36
|
|
Overall Study
Laboratory Session 3
|
40
|
33
|
|
Overall Study
Laboratory Session 4
|
39
|
33
|
|
Overall Study
COMPLETED
|
38
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating New Nicotine Standards for Cigarettes - Project 3
Baseline characteristics by cohort
| Measure |
Normal Nicotine Content Cigarettes
n=41 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.9 years
STANDARD_DEVIATION .7 • n=5 Participants
|
18.7 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
18.8 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender male to female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender female to male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Genderqueer/gender non-conforming
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Different identity
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
39 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Average Cigarettes Per Day
|
5.8 Cigarettes smoked per day
STANDARD_DEVIATION 5.6 • n=5 Participants
|
4.7 Cigarettes smoked per day
STANDARD_DEVIATION 3.6 • n=7 Participants
|
5.3 Cigarettes smoked per day
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Fagerstom Test for Nicotine Dependence
|
2.6 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30-minute preference taskPopulation: Laboratory session 1
The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=41 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of Cigarette Puffs Taken (0 to 20)
|
12.1 Puffs chosen
Standard Deviation 5.0
|
10.8 Puffs chosen
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalance laboratory sessions 2-5
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor
|
8.9 Puffs chosen
Standard Deviation 5.6
|
5.2 Puffs chosen
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=40 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Non-tobacco Flavors
|
8.0 Puffs chosen
Standard Deviation 5.0
|
4.6 Puffs chosen
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor
|
9.4 Puffs chosen
Standard Deviation 5.4
|
4.7 Puffs chosen
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Non-tobacco Flavors
|
8.6 Puffs chosen
Standard Deviation 5.4
|
4.5 Puffs chosen
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 30-minute preference task sessionThe number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
|
6.6 vape puffs
Standard Deviation 5.0
|
10.5 vape puffs
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 30-minute preference task sessionPopulation: Counterbalance laboratory session 205
The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=40 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
|
7.2 vape puffs
Standard Deviation 4.6
|
11.0 vape puffs
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 30-minute preference task sessionThe number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
|
4.3 vape puffs
Standard Deviation 4.3
|
8.2 vape puffs
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 30-minute preference task sessionThe number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
|
5.2 vape puffs
Standard Deviation 5.0
|
11.0 vape puffs
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 30-minute preference taskPopulation: Laboratory session 1
Post-choice CO minus pre-choice CO at session 1 in which no vaping device was available
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=41 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available
|
5.9 parts per million
Standard Deviation 4.3
|
6.7 parts per million
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 30-minute preference taskPopulation: Laboratory session 1
Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
|
4.4 parts per million
Standard Deviation 3.2
|
3.8 parts per million
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=40 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Carbon Monoxide Change From pre-to the Post-choice Taskwhen the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors
|
3.9 parts per million
Standard Deviation 3.6
|
3.6 parts per million
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=33 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
|
4.3 parts per million
Standard Deviation 3.4
|
2.7 parts per million
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 30-minute preference taskPopulation: Counterbalanced laboratory sessions 2-5
Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors
Outcome measures
| Measure |
Normal Nicotine Content Cigarettes
n=39 Participants
Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
Very Low Nicotine Content Cigarettes
n=34 Participants
Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar
Spectrum Research Cigarettes: Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
|
|---|---|---|
|
Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors
|
4.0 parts per million
Standard Deviation 2.4
|
3.3 parts per million
Standard Deviation 3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-minute preference task at each of the 5 laboratory sessions0 to 10
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-minute preference task at each of the 5 laboratory sessions0 to 10
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-minute preference task at each of the 5 laboratory sessions0 to 10
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures of compliance
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures withdrawal symptoms
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures craving
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures positive and negative affect
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures subjective responses cigarettes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures demand for cigarettes across a range of prices
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures perceived risk of cigarettes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures of cardiovascular function
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksMeasures of cardiovascular function
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Week 1Biomarkers
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Week 1Biomarkers
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Week 1Biomarkers: measures a metabolite of nicotine
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeksBiomarkers: measures expired alveolar carbon monoxide level
Outcome measures
Outcome data not reported
Adverse Events
Normal Nicotine Content Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Very Low Nicotine Content Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place