Sugars in Cigarettes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Impact of Sugar Content 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
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
|
Outcome Measures
Primary Outcome Measures
- To evaluate the impact of sugar content on behavioral measures [End of Intervention (2-3 Weeks from enrollment)]
Evaluate the impact of sugar content on behavioral measures with either Modified Cigarette Evaluation Questionnaire (mCEQ) or The Multiple Choice Procedure task
- To evaluate the impact of sugar content on smoking intensity [End of Intervention (2-3 Weeks from enrollment)]
Measure the amount of nicotine levels in the spend filters during the controlled puffing pattern.
- To evaluate the impact of sugar content on subjective responses to cigarettes (e.g., reinforcing and sensory effects) [End of Intervention (2-3 Weeks from enrollment)]
Use the Sensory Effect of Smoking Questionnaire (SESQ) or Minnesota Nicotine Withdraw Scale (MNWS) to quantify
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female age 21 years or older
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Smoking cigarettes that have been evaluated to have medium levels of sugar content
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No quit attempts in the past month nor intentions to quit smoking in the next month
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Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
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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
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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
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Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
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Participants have provided written informed consent to participate in the study.
Exclusion Criteria:
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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
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Women who are pregnant or nursing or planning to become pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- Masonic Cancer Center, University of Minnesota
Investigators
- Principal Investigator: Irina Stepanov, PhD, University of Minnesota, Division of Environmental Health Sciences
- Principal Investigator: Dorothy Hatsukami, Masonic Cancer Center Tobacco Research Programs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020LS236