Sugars in Cigarettes

NCT05308316 | Completed Results

• 2 other identifiers: 2020LS236R01DA051005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the impact of sugar levels in cigarette tobacco on cigarette abuse liability and appeal. Participants will attend several clinic visits to smoke cigarettes with different levels of sugars and will complete multiple questionnaires to assess their experiences. Each of the sessions will be separated by at least 48 hours but not more than 5 days. The hypothesis is that the measures collected in this study will indicate lower abuse liability for cigarettes with lowest sugar content.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (2)

• Impact of Cigarette Sugar Content on Product Satisfaction.

  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.

  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)

• Impact of Sugar Content on Behavioral Outcomes Using the Multiple Choice Procedure Task.

  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.

  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)

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Impact of Sugar Content

EXPERIMENTAL

Participants will be asked to attend 4 laboratory sessions during which they will 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: Cigarettes with added sucrose

Interventions

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.

Impact of Sugar Content

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Irina Stepanov
• Organization: Masonic Cancer Center

stepa011@umn.edu

612-624-4998

Study Officials

• Irina Stepanov, PhD

  University of Minnesota, Division of Environmental Health Sciences

  PRINCIPAL INVESTIGATOR

• Dorothy Hatsukami

  Masonic Cancer Center Tobacco Research Programs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: April 4, 2022
• Study Start: February 24, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 9, 2025
• Last Updated: February 27, 2026
• Results First Posted: January 6, 2026

Record last verified: 2026-02

Locations

US (1)