Sugars in Cigarettes

Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05308316

Enrollment

Registered

2022-04-04

Start date

2022-02-24

Completion date

2025-10-09

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

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.

Interventions

OTHERCigarettes 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Impact of Cigarette Sugar Content on Product Satisfaction.	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.
Impact of Sugar Content on Behavioral Outcomes Using the Multiple Choice Procedure Task.	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.

Secondary

Measure	Time frame	Description
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)	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.
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)	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).
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)	Measure the amount of nicotine levels in the spend filters during the controlled puffing pattern. Nicotine levels will be determined through LC/MS.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORIrina Stepanov, PhD

University of Minnesota, Division of Environmental Health Sciences

PRINCIPAL_INVESTIGATORDorothy Hatsukami

Masonic Cancer Center Tobacco Research Programs

Participant flow

Recruitment details

Participants completed all three arms/sugar levels for the duration of the study.

Pre-assignment details

Prior to being randomized to order of smoking study cigarettes all participants smoked their usual brand cigarettes. Each participant smoked all 3 versions of the study cigarettes (i.e., the 3 sugar levels). Participants were randomized to the order of smoking these different versions of cigarettes. Participants did not complete study due to withdrawal and physician decision.

Participants by arm

Arm	Count
Impact of Sugar Content: All Participants After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke 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. 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	30
Total	30

Arm

Count

Impact of Sugar Content: All Participants

After completing baseline assessment, participants will be asked to attend 3 laboratory sessions during which they will be asked to smoke 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. 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

Total

Baseline characteristics

Characteristic	Impact of Sugar Content: All Participants
Age, Continuous	46.1 years STANDARD_DEVIATION 11.4
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	25 Participants
Region of Enrollment United States	30 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

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.