Sugars in Cigarettes

February 6, 2026 updated by: Masonic Cancer Center, University of Minnesota

Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hanna Vanderloo, RN, MSN
  • Phone Number: 612.624.4983
  • Email: hannav@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Impact of Sugar Content
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact of Cigarette Sugar Content on Product Satisfaction.
Time Frame: 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.
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.
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other Subjective and Behavioral Measures: Effects/Liking
Time Frame: 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.
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
Time Frame: 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).
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
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masonic Cancer Center, University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Irina Stepanov, PhD, University of Minnesota, Division of Environmental Health Sciences
  • Principal Investigator: Dorothy Hatsukami, Masonic Cancer Center Tobacco Research Programs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020LS236
  • R01DA051005 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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