Sugars in Cigarettes

Study Overview
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Brief Summary
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To investigate a comprehensive set of abuse liability and appeal measures, smoking intensity, as well as analyze the impact of sugar content on the formation in the oral cavity of smokers of DNA adducts derived from aldehydes and oxidative stress.

Official Title
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Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Sucrose cigarettes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impact of Sugar Content<br>Participants will be ask to attend 4 laboratory sessions during which they will be asked to smoke their usual brand (UB) cigarettes and then 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. | Other: Sucrose cigarettes<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of sugar content on behavioral measures | Evaluate the impact of sugar content on behavioral measures with either Modified Cigarette Evaluation Questionnaire (mCEQ) or The Multiple Choice Procedure task. The mCEQ has 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. There are 12 total questions in the mCEQ we are using here. | End of Intervention (2-3 Weeks from enrollment) | 
| To evaluate the impact of sugar content on smoking intensity | Measure the amount of nicotine levels in the spend filters during the controlled puffing pattern. Nicotine levels will be determined through LC/MS. | End of Intervention (2-3 Weeks from enrollment) | 
| To evaluate the impact of sugar content on subjective responses to cigarettes (e.g., reinforcing and sensory effects) | Use the Sensory Effect of Smoking Questionnaire (SESQ) or Minnesota Nicotine Withdraw Scale (MNWS) to quantify. The SESQ also uses a 7-point Likert scale ranging from 1 Not at all to 7 Extremely. This survey is focused on the sensory effects of smoking so a lower score would mean lower favorability, strength and effect of the cigarette on a participant. There are a total of 9 questions on the SESQ used for this study. | End of Intervention (2-3 Weeks from enrollment) |