Trial Outcomes & Findings for Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors (NCT NCT02000921)
NCT ID: NCT02000921
Last Updated: 2017-03-31
Results Overview
The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
8 week intervetnion period
Results posted on
2017-03-31
Participant Flow
Participant milestones
| Measure |
CN + Combusted & Non-combusted Products
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
53
|
56
|
|
Overall Study
COMPLETED
|
22
|
37
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
16
|
10
|
Reasons for withdrawal
| Measure |
CN + Combusted & Non-combusted Products
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
5
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
Baseline Characteristics
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Baseline characteristics by cohort
| Measure |
CN + Combusted & Non-combusted Products
n=27 Participants
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=53 Participants
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=56 Participants
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 14 • n=5 Participants
|
44 years
STANDARD_DEVIATION 15 • n=7 Participants
|
45 years
STANDARD_DEVIATION 15 • n=5 Participants
|
44 years
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 week intervetnion periodThe primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Outcome measures
| Measure |
CN + Combusted & Non-combusted Products
n=27 Participants
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=53 Participants
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=56 Participants
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Number of Days Using Alternative Products
|
14 Number of days
Standard Deviation 17
|
26 Number of days
Standard Deviation 19
|
20 Number of days
Standard Deviation 19
|
PRIMARY outcome
Timeframe: At weeks 6-8 (last two weeks of intervention period)Number of combusted products smoked per day during the last two weeks of the intervention period.
Outcome measures
| Measure |
CN + Combusted & Non-combusted Products
n=22 Participants
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=37 Participants
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=46 Participants
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Number of Combusted Products Smoked
|
19.2 combuster products per day
Standard Deviation 8.1
|
12.9 combuster products per day
Standard Deviation 7.6
|
13.5 combuster products per day
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 8 week intervention periodRate of 24 hour quit attempts during the intervention period
Outcome measures
| Measure |
CN + Combusted & Non-combusted Products
n=27 Participants
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=53 Participants
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=56 Participants
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Rate of 24 Hour Quit Attempts
|
2 Participants
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 8 (end of intervention)Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.
Outcome measures
| Measure |
CN + Combusted & Non-combusted Products
n=22 Participants
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=37 Participants
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=46 Participants
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Carcinogen Exposure Biomarker: Total NNAL
|
1.22 pmol//mg creatinine
Interval 0.91 to 1.65
|
0.71 pmol//mg creatinine
Interval 0.41 to 1.23
|
0.51 pmol//mg creatinine
Interval 0.35 to 0.74
|
Adverse Events
CN + Combusted & Non-combusted Products
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VLNC + Combusted & Non-combusted Products
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VLNC With Non-combusted Products
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CN + Combusted & Non-combusted Products
n=27 participants at risk
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=53 participants at risk
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=56 participants at risk
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/27 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
1.8%
1/56 • Number of events 1 • During the 8 week intervention
|
Other adverse events
| Measure |
CN + Combusted & Non-combusted Products
n=27 participants at risk
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content.
|
VLNC + Combusted & Non-combusted Products
n=53 participants at risk
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
VLNC With Non-combusted Products
n=56 participants at risk
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
14.3%
8/56 • Number of events 8 • During the 8 week intervention
|
|
General disorders
Headache
|
0.00%
0/27 • During the 8 week intervention
|
13.2%
7/53 • Number of events 7 • During the 8 week intervention
|
8.9%
5/56 • Number of events 5 • During the 8 week intervention
|
|
General disorders
Irritability
|
7.4%
2/27 • Number of events 2 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
0.00%
0/56 • During the 8 week intervention
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/27 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
5.4%
3/56 • Number of events 3 • During the 8 week intervention
|
|
General disorders
Sore throat
|
0.00%
0/27 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
12.5%
7/56 • Number of events 7 • During the 8 week intervention
|
|
General disorders
Difficulty concentrating
|
7.4%
2/27 • Number of events 2 • During the 8 week intervention
|
0.00%
0/53 • During the 8 week intervention
|
0.00%
0/56 • During the 8 week intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place