Sucrose Cigarettes for Tobacco Use

Overseen By Hanna Vanderloo, RN, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Immune disorders, Respiratory diseases, Kidney, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2-3 weeks

38 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sucrose cigarettes for tobacco use?

Research suggests that sucrose can reduce certain withdrawal symptoms like drowsiness and anxiety during tobacco abstinence, which might help people trying to quit smoking. Additionally, sucrose has been shown to enhance cognitive performance, which could potentially support individuals in managing withdrawal symptoms. ^{1 2 3 4 5}

Is it safe to use sucrose in cigarettes?

Research suggests that adding sugars like sucrose to cigarettes does not increase the risk or harm of smoking. Studies have shown that the smoke from cigarettes with added sugars does not significantly differ in harmfulness compared to those without added sugars. ^{6 7 8 9 10}

How do sucrose cigarettes differ from other treatments for tobacco use?

Sucrose cigarettes are unique because they incorporate sugar into the cigarette, which is not a common ingredient in traditional tobacco products. This approach is different from other treatments like nicotine replacement therapies or smokeless tobacco products, which focus on reducing nicotine intake or providing alternatives to smoking. ^{11 12 13 14 15}

Research Team

Irina Stepanov, PhD

Principal Investigator

University of Minnesota, Division of Environmental Health Sciences

Dorothy Hatsukami

Principal Investigator

Masonic Cancer Center Tobacco Research Programs

Eligibility Criteria

This trial is for adults over 21 who currently smoke cigarettes with medium sugar content. They must be in good physical and mental health, have stable vital signs, and not plan to quit smoking within the next month. Pregnant or nursing women, those planning pregnancy, or individuals with significant medical conditions affecting biomarker data cannot participate.

Inclusion Criteria

Participants have provided written informed consent to participate in the study.

My blood pressure and heart rate are within a safe range.

No quit attempts in the past month nor intentions to quit smoking in the next month

Exclusion Criteria

I do not have major immune, respiratory, kidney, or liver diseases that could affect test results.

I am not pregnant, nursing, or planning to become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 4 laboratory sessions to smoke their usual brand and study cigarettes with varying sugar levels

2-3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sucrose cigarettes

Trial Overview The study is examining how different levels of sugar in cigarettes affect smokers' appeal towards smoking, their intensity of smoking, and the potential risks such as DNA damage in the mouth from aldehydes and oxidative stress caused by sugars during smoking.

Participant Groups

Group I: Impact of Sugar Content Experimental Treatment 1 Intervention

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.

Sucrose cigarettes is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Approved in United States as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Approved in Canada as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Approved in Japan as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Approved in China as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Approved in Switzerland as Sucrose cigarettes for:

• None, as cigarettes are regulated differently

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Findings from Research

In a study of 314 daily smokers, starting nicotine polacrilex gum treatment 4 weeks before the quit date did not significantly improve smoking abstinence rates compared to starting on the quit date.

Both groups showed similar self-reported and biochemically verified abstinence rates after 12 months, indicating that the timing of nicotine gum initiation may not impact long-term quitting success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine gum treatment before smoking cessation: a randomized trial. Etter, JF., Huguelet, P., Perneger, TV., et al.[2018]

In a study involving 67 women, consuming sucrose after 12 hours of tobacco abstinence was found to reduce symptoms of drowsiness and anxiety related to withdrawal.

While sucrose helped with some withdrawal symptoms, it did not affect others like restlessness and irritability, suggesting that carbohydrate intake may only modestly alleviate certain aspects of tobacco withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sucrose on acute tobacco withdrawal in women. Helmers, KF., Young, SN.[2019]

Tobacco smoking is the leading cause of preventable death in the U.S., but there are now more evidence-based resources available for physicians to help patients quit, including new pharmacotherapies and community programs.

Electronic nicotine delivery systems may offer potential benefits as treatment tools for smoking cessation, but their safety and efficacy still require further investigation, especially for high-priority groups like cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation. Patel, MS., Patel, SB., Steinberg, MB.[2022]

In a study of 197 patients, nicotine chewing gum combined with a self-help manual was more effective for smoking cessation at six weeks compared to a self-help manual alone or a control group.

However, by one year, the initial benefits of nicotine gum diminished, with many participants relapsing, suggesting that long-term success may depend more on behavioral support than on nicotine replacement alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine gum and self-help manuals in smoking cessation: an evaluation in a medical context. Harackiewicz, JM., Blair, LW., Sansone, C., et al.[2019]

In a study with 14 healthy smokers, nicotine significantly improved performance on a continuous performance task (CPT), leading to more correct responses and fewer mistakes, especially when combined with a sucrose-containing beverage.

The combination of nicotine and sucrose showed additive effects on cognitive performance, enhancing task accuracy, while sucrose alone improved spatial memory performance in the first session compared to aspartame, although neither substance affected mood or spatial memory consistently across sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of nicotine and sucrose on spatial memory and attention. Harte, CB., Kanarek, RB.[2015]

A new analytical method using high-performance liquid chromatography and tandem mass spectrometry was developed to effectively measure sucrose and other saccharides in e-liquids for electronic cigarettes, showing a detection limit of 0.73 μg/g.

The study found that sucrose was present in all tested e-liquids, with concentrations ranging from 0.76 to 72.93 μg/g, highlighting the need to understand its potential impact on smoking and nicotine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of sucrose as a possible contaminant in e-liquids for electronic cigarettes by hydrophilic interaction liquid chromatography-tandem mass spectrometry. Kubica, P., Wasik, A., Kot-Wasik, A., et al.[2021]

A tiered testing strategy involving multiple studies showed that adding up to 5% high fructose corn syrup (HFCS) to cigarettes does not change the chemical composition or biological activity of mainstream cigarette smoke compared to traditional corn syrup/invert sugar.

The studies included various assessments such as genotoxicity and inhalation toxicity, and found no significant differences in harmful effects between cigarettes with HFCS and those with standard casing materials, indicating that HFCS does not pose additional risks in the context of tobacco smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of high fructose corn syrup (HFCS) as an ingredient added to cigarette tobacco. Stavanja, MS., Ayres, PH., Meckley, DR., et al.[2023]

A study analyzing the effects of sugar in American-blend cigarettes found that while some smoke constituents changed with increased sugar levels, these changes did not significantly affect the overall toxicity or harm of the smoke.

Comparative data from markets with sugar-added American-blend cigarettes and those with Virginia-type cigarettes showed no relevant differences in smoking prevalence, nicotine uptake, or smoking-related health issues, suggesting that adding sugars does not increase the risks associated with smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific assessment of the use of sugars as cigarette tobacco ingredients: a review of published and other publicly available studies. Roemer, E., Schorp, MK., Piadé, JJ., et al.[2023]

A study of 66 e-cigarette liquids found that sugars like glucose, fructose, and sucrose were present in significant amounts, with sucrose levels being notably higher than the other sugars.

Toxic aldehydes such as formaldehyde, acetaldehyde, and acrolein were also detected in high levels in the e-liquids, raising concerns about their potential toxicity and implications for user safety, especially among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugar and Aldehyde Content in Flavored Electronic Cigarette Liquids. Fagan, P., Pokhrel, P., Herzog, TA., et al.[2023]

Adding sugars like glucose and fructose to high- and low-tar cigarettes significantly reduced the mutagenicity of their smoke condensates, with reductions observed to as low as 22% of untreated cigarettes' mutagenicity.

The study, which used Salmonella typhimurium strains TA98 and TA100 to assess mutagenicity, found that while sugars increased the total smoke condensate amounts, they also decreased the specific mutagenicity, particularly in high-tar cigarettes, suggesting a complex interaction between sugar content and smoke toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in mutagenicity of cigarette smoke condensate by added sugars. Sato, S., Ohka, T., Nagao, M., et al.[2019]

Ultralow-nicotine cigarettes and menthol brands in Japan lead to compensation smoking and promote dependence, raising concerns about their safety and effectiveness in reducing nicotine intake.

Despite the known carcinogenic risks of tobacco products, Japan has been slow to implement WHO regulations aimed at controlling tobacco product contents and disclosures, highlighting a need for urgent action from government authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The need for tobacco control in Japan based on Articles 9 and 10 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), regulation of the contents of tobacco products, and regulation of tobacco product disclosures]. Inaba, Y., Uchiyama, S., Kunugita, N.[2023]

The FDA's approval of smokeless tobacco products highlights their increasing popularity, especially in low- and middle-income countries, and raises concerns about aggressive marketing strategies targeting youth and current smokers.

Smokeless tobacco is linked to serious health risks, including various cancers and cardiovascular diseases, and there is no strong evidence that it helps people quit smoking; instead, it may encourage cigarette smoking, particularly among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Requiring Graphic Warning Labels on Smokeless Tobacco Product Packages. Pakhale, S., Samet, J., Folan, P., et al.[2022]

Smokers perceive low-nicotine cigarettes as less satisfying and strong, indicating that nicotine is a key factor in their smoking experience, while tar does not influence these perceptions.

The study suggests that nicotine plays a crucial role in maintaining smoking behavior, and that cigarettes designed to be less harmful should deliver higher nicotine levels relative to tar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactions to cigarettes as a function of nicotine and "tar". Goldfarb, T., Gritz, ER., Jarvik, ME., et al.[2019]

In a study involving 15 smokers, Swedish-style snus (SS) was found to significantly reduce the intention to smoke and delay the onset of smoking in men, indicating its potential as a smoking cessation aid.

Despite its effectiveness in reducing cravings, SS was associated with increased frustration and irritability compared to nicotine lozenges, and it was ranked as the least preferred product among participants, suggesting limited acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effect of Swedish-style snus on cigarette craving and self-administration in male and female smokers. Barrett, SP., Campbell, ML., Temporale, K., et al.[2018]

A review of 28 studies, including 5 randomized controlled trials, found no significant evidence that Swedish snus effectively promotes smoking cessation, although some observational studies suggested a potential association with increased quitting rates.

The overall evidence for snus as a smoking cessation aid is weak, and the authors recommend further high-quality research, suggesting that existing cessation aids may be more effective than snus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of smokeless tobacco for smoking cessation: a systematic review and meta-analysis. Stjepanović, D., Phartiyal, P., Leung, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nicotine gum treatment before smoking cessation: a randomized trial. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

The effect of sucrose on acute tobacco withdrawal in women. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Smoking Cessation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Nicotine gum and self-help manuals in smoking cessation: an evaluation in a medical context. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The effects of nicotine and sucrose on spatial memory and attention. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

An evaluation of sucrose as a possible contaminant in e-liquids for electronic cigarettes by hydrophilic interaction liquid chromatography-tandem mass spectrometry. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety assessment of high fructose corn syrup (HFCS) as an ingredient added to cigarette tobacco. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Scientific assessment of the use of sugars as cigarette tobacco ingredients: a review of published and other publicly available studies. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Sugar and Aldehyde Content in Flavored Electronic Cigarette Liquids. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Reduction in mutagenicity of cigarette smoke condensate by added sugars. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

[The need for tobacco control in Japan based on Articles 9 and 10 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), regulation of the contents of tobacco products, and regulation of tobacco product disclosures]. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

The Case for Requiring Graphic Warning Labels on Smokeless Tobacco Product Packages. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Reactions to cigarettes as a function of nicotine and "tar". [2019]

14. England pubmed.ncbi.nlm.nih.gov

The acute effect of Swedish-style snus on cigarette craving and self-administration in male and female smokers. [2018]

15. England pubmed.ncbi.nlm.nih.gov

Efficacy of smokeless tobacco for smoking cessation: a systematic review and meta-analysis. [2023]