Sugars in Cigarettes

• Cigarettes with added sucrose (Other): Winston brand cigarettes will be modified by adding 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 cigarette brands.

Primary outcomes

• Impact of Cigarette Sugar Content on Product Satisfaction. [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.
• Impact of Sugar Content on Behavioral Outcomes Using the Multiple Choice Procedure Task. [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.

Secondary outcomes

• Other Subjective and Behavioral Measures: Effects/Liking [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.
• Other Subjective and Behavioral Measures: Sensory Effect of Smoking [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).
• To Evaluate the Impact of Sugar Content on Smoking Intensity [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.

Sex: All, ages: 21 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Male or female age 21 years or older
* Smoking cigarettes that have been evaluated to have medium levels of sugar content
* No quit attempts in the past month nor intentions to quit smoking in the next month
* Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
* Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
* Stable vitals sign measurements (systolic BP ≤ 160 and >90 mmHg, diastolic BP ≤ 100 and >50 mmHg and heart rate ≤105 and > 45 bpm) as determined by the licensed medical professional
* Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
* Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
* Women who are pregnant or nursing or planning to become pregnant.

Participant flow

Outcome results

• Impact of Cigarette Sugar Content on Product Satisfaction. (Primary), Mean, units on a scale: Low Sugar Content 4.09 +/- 1.85; Medium Sugar Content 3.89 +/- 1.77; High Sugar Content 3.92 +/- 1.87; Usual Brand Cigarette 4.39 +/- 1.33
• Impact of Sugar Content on Behavioral Outcomes Using the Multiple Choice Procedure Task. (Primary), Mean, Dollars: Low Sugar Content 47.6 +/- 123.64; Medium Sugar Content 27.20 +/- 99.77; High Sugar Content 72.40 +/- 147.8; Usual Brand Cigarette 113.8 +/- 159.5
• Other Subjective and Behavioral Measures: Effects/Liking (Secondary), Mean, units on a scale: Low Sugar Content 47.85 +/- 29.59; Medium Sugar Content 44.40 +/- 27.70; High Sugar Content 47.33 +/- 27.07; Usual Brand Cigarette 66.45 +/- 23.40
• Other Subjective and Behavioral Measures: Sensory Effect of Smoking (Secondary), Mean, units on a scale: Low Sugar Content 3.33 +/- 0.78; Medium Sugar Content 3.16 +/- 1.02; High Sugar Content 3.42 +/- 1.22; Usual Brand Cigarette 3.29 +/- 1.04
• To Evaluate the Impact of Sugar Content on Smoking Intensity (Secondary)

Adverse events

Time frame: Baseline to fourth session, up to 3 months

• Study Protocol and Statistical Analysis Plan (PDF, 2023-12-01)
• Informed Consent Form (PDF, 2022-05-02)

• Irina Stepanov, PhD, Principal investigator, University of Minnesota, Division of Environmental Health Sciences
• Dorothy Hatsukami, Principal investigator, Masonic Cancer Center Tobacco Research Programs

NIH grants: R01DA051005