Sugars in Cigarettes

Tobacco Use Clinical Trial

Official title:

Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308316
• Other study ID #: 2020LS236
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Hanna Vanderloo, RN, MSN
• Phone: 612.624.4983
• Email: hannav[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)