Trial Outcomes & Findings for Sugars in Cigarettes (NCT NCT05308316)
NCT ID: NCT05308316
Last Updated: 2026-01-06
Results Overview
Product satisfaction will be measured using Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ will involve 5 items rated on a 7-point Likert scale ranging from 1 "Not at all" to 7 "Extremely". A lower score would indicate less satisfaction, enjoyment smoking the assigned cigarette.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)
Results posted on
2026-01-06
Participant Flow
Participants completed all three arms/sugar levels for the duration of the study.
Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes. Each participant smoked all 3 versions of the study cigarettes (i.e., the 3 sugar levels). Participants were randomized to the order of smoking these different versions of cigarettes. Participants did not complete study due to withdrawal and physician decision.
Participant milestones
| Measure |
Impact of Sugar Content: All Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
Usual Brand
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27
|
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Overall Study
Low Sugar
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27
|
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Overall Study
Medium Sugar
|
27
|
|
Overall Study
High Sugar
|
27
|
|
Overall Study
COMPLETED
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27
|
|
Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Impact of Sugar Content: All Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
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|---|---|
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Overall Study
Withdrawal by Subject
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2
|
|
Overall Study
Physician Decision
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1
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Baseline Characteristics
Sugars in Cigarettes
Baseline characteristics by cohort
| Measure |
Impact of Sugar Content: All Participants
n=30 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
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|---|---|
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Age, Continuous
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46.1 years
STANDARD_DEVIATION 11.4 • n=37 Participants
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Sex: Female, Male
Female
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10 Participants
n=37 Participants
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Sex: Female, Male
Male
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20 Participants
n=37 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=37 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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27 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=37 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=37 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=37 Participants
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|
Race (NIH/OMB)
White
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25 Participants
n=37 Participants
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|
Race (NIH/OMB)
More than one race
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1 Participants
n=37 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=37 Participants
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Region of Enrollment
United States
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30 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)Product satisfaction will be measured using Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ will involve 5 items rated on a 7-point Likert scale ranging from 1 "Not at all" to 7 "Extremely". A lower score would indicate less satisfaction, enjoyment smoking the assigned cigarette.
Outcome measures
| Measure |
Low Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Medium Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
High Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Usual Brand Cigarette
n=25 Participants
Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes.
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|---|---|---|---|---|
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Impact of Cigarette Sugar Content on Product Satisfaction.
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4.09 units on a scale
Standard Deviation 1.85
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3.89 units on a scale
Standard Deviation 1.77
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3.92 units on a scale
Standard Deviation 1.87
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4.39 units on a scale
Standard Deviation 1.33
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PRIMARY outcome
Timeframe: At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)Outcome measures for the Multiple Choice Procedure task are breakpoint (price at which participant switches from the study cigarette to money), elasticity (changes in consumption in response to changes in price); intensity (consumption at $0.00 price); Omax (maximum expenditure); and Pmax (price corresponding to Omax). Multiple Choice Procedure determines the price at which participants would switch from product to money, called the crossover point. Products with lower abuse liability tend to have a lower crossover point.
Outcome measures
| Measure |
Low Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Medium Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
High Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Usual Brand Cigarette
n=25 Participants
Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes.
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|---|---|---|---|---|
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Impact of Sugar Content on Behavioral Outcomes Using the Multiple Choice Procedure Task.
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47.6 Dollars
Standard Deviation 123.64
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27.20 Dollars
Standard Deviation 99.77
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72.40 Dollars
Standard Deviation 147.8
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113.8 Dollars
Standard Deviation 159.5
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SECONDARY outcome
Timeframe: At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)Drug Effects/Liking Questionnaire is used to assess abuse liability of drugs and measures overall desirability of the product and intention to use in the future. Range from 0 - 100. A score of 0 being the weakest possible score, with 100 being the strongest score. Answers to questionnaire are averaged to calculate a composite score.
Outcome measures
| Measure |
Low Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Medium Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
High Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Usual Brand Cigarette
n=25 Participants
Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes.
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|---|---|---|---|---|
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Other Subjective and Behavioral Measures: Effects/Liking
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47.85 units on a scale
Standard Deviation 29.59
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44.40 units on a scale
Standard Deviation 27.70
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47.33 units on a scale
Standard Deviation 27.07
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66.45 units on a scale
Standard Deviation 23.40
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SECONDARY outcome
Timeframe: At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)Sensory Effect of Smoking Questionnaire (SESQ) uses a 7-point Likert scale ranging from 1 "Not at all" to 7 "Extremely", with a lower score indicating lower favorability, strength and effect of the cigarette on a participant. Five questions in this SESQ used for this study deal with the sensation of the strength of smoke impact on tongue, nose, mouth and throat, windpipe, and chest. Responses to each question were averaged to calculate final score. Total average minimum is one (lower effect) and total average maximum is seven (higher effect).
Outcome measures
| Measure |
Low Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Medium Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
High Sugar Content
n=25 Participants
After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
Sucrose cigarettes: Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed
|
Usual Brand Cigarette
n=25 Participants
Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes.
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|---|---|---|---|---|
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Other Subjective and Behavioral Measures: Sensory Effect of Smoking
|
3.33 units on a scale
Standard Deviation 0.78
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3.16 units on a scale
Standard Deviation 1.02
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3.42 units on a scale
Standard Deviation 1.22
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3.29 units on a scale
Standard Deviation 1.04
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SECONDARY outcome
Timeframe: At each session, 2 hours post all puffs (assessed at all 4 sessions, each session was up to 4 hours, and all sessions took place between 2-3 weeks post enrollment, separated by 2-5 days)Measure the amount of nicotine levels in the spend filters during the controlled puffing pattern. Nicotine levels will be determined through LC/MS.
Outcome measures
Outcome data not reported
Adverse Events
Impact of Sugar Content
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