E-Cigarette Additives for Smoking Perceptions

(ICE Trial)

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Recent COVID-19, Cardiac event, Pregnancy, Serious lung disease, Bleeding disorder, Severe disability, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 sessions

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for smoking cessation?

Behavioral treatments, including lifestyle and non-pharmacological interventions, have been shown to be effective for smoking cessation, often achieving long-term abstinence rates of up to 50% when used in intensive multicomponent programs. These treatments are considered cost-effective and can be as beneficial as pharmacotherapies like nicotine replacement therapy. ^{1 2 3 4 5}

Is the use of e-cigarettes generally safe for humans?

Research suggests that electronic cigarettes (e-cigarettes) are generally considered less harmful than traditional smoking and nicotine replacement therapies, but they can still cause some adverse events (unwanted effects). Common side effects may include throat irritation, cough, and nausea, but these are typically less severe than those associated with smoking traditional cigarettes. ^{6 7 8 9 10}

How does the treatment involving e-cigarette additives differ from other smoking cessation treatments?

This treatment is unique because it focuses on how e-cigarette additives influence people's perceptions of smoking risks, which can affect their behavior. Unlike traditional nicotine replacement therapies, this approach considers both the chemical and sensory aspects of e-cigarettes, which may help address cravings and smoking habits in a different way. ^{9 11 12 13 14}

Research Team

Alayna P. Tackett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals who use tobacco products, specifically those interested in or currently using e-cigarettes. Participants should be willing to provide feedback through surveys and allow collection of biological samples.

Inclusion Criteria

I agree to not use electronic cigarettes 12 hours before lab sessions.

Current exclusive e-cigarette (EC) user (defined as ≥ weekly use over the past 3 months)

Not currently using another tobacco/nicotine product (defined as no use in the past 6 months)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes and engage in vaping, surveys, and biosample collection.

4 sessions

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral Intervention

Trial Overview The study is looking at the effects of synthetic cooling additives (WS-3 and WS-23) on how people perceive e-cigarettes, their usage habits, and exposure to harmful substances.

Participant Groups

Group I: Fruit flavored e-cigarette with synthetic cooling agents added Active Control 3 Interventions

Synthetic cooling agents will be added to fruit flavored e-liquid for this condition.

Group II: Fruit flavored e-cigarette Active Control 3 Interventions

Fruit flavored e-liquid will be used for this condition.

Group III: Tobacco flavored e-cigarette Active Control 3 Interventions

Tobacco flavored e-liquid will be used for this condition.

Group IV: Tobacco flavored e-cigarette with synthetic cooling agents added Active Control 3 Interventions

Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Nicotine replacement therapies have been shown to be effective in helping smokers quit, supported by large sample sizes and robust evaluation methods in the research.

There is no consistent evidence that one psychological treatment method is superior to others for smoking cessation, but intensive clinic-based treatments and brief community-oriented interventions are both important approaches, with the latter being more scalable for reducing overall smoking prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatments for smokers. Hajek, P.[2019]

Nicotine replacement therapy (NRT) and sustained-release bupropion (bupropion SR) are effective pharmacotherapies for smoking cessation, increasing quit rates by 1.5 to over 2 times when combined with behavioral interventions.

National and international guidelines recommend systematic approaches for smoking cessation, including identifying smokers, assessing their readiness to quit, providing supportive advice, and administering approved therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of smoking cessation. Sutherland, G.[2018]

Intensive multicomponent behavioral interventions can lead to long-term smoking cessation rates of nearly 50%, highlighting their effectiveness compared to other methods.

Nicotine replacement therapies, such as gum and patches, significantly enhance smoking cessation outcomes, with patches being easier for patients to use correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation products and programs. Lando, HA.[2007]

Behavioral treatments for tobacco use are effective and cost-effective, comparable to pharmacotherapies, but have not advanced as quickly in recent years.

There is a need for more research on tobacco cessation interventions specifically for cancer patients, and clinicians are encouraged to use the Five A's approach to support these patients in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? Brandon, TH.[2007]

Health professionals can significantly improve patient outcomes related to tobacco use by implementing ten practical recommendations that enhance the delivery of tobacco interventions in clinical settings.

These recommendations focus on integrating tobacco treatment into routine clinical workflows, emphasizing the importance of evidence-based treatments, and ensuring that every patient encounter is an opportunity for intervention, ultimately aiming to reduce social disparities among tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. Woods, SS., Jaén, CR.[2010]

This pilot study involves 60 COPD patients and compares the effectiveness of standard smoking cessation care (counseling and nicotine replacement therapy) with counseling plus electronic cigarettes (EC) over 12 weeks, aiming to identify barriers and facilitators to EC use.

The study seeks to assess the feasibility and acceptability of EC as a harm reduction strategy, with the potential to help COPD patients reduce their cigarette consumption or quit smoking altogether, addressing a significant health need for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial. Stevens, ER., Lei, L., Cleland, CM., et al.[2022]

A significant majority of smokers and recent ex-smokers in the UK (57.3% for e-cigarettes and 63.4% for nicotine replacement therapy) perceive these alternatives as less harmful than traditional smoking, indicating a general awareness of their reduced risk.

However, misconceptions persist, particularly among those who have never vaped and those with inaccurate knowledge about nicotine, leading to concerns about e-cigarettes related to research gaps, regulation, and chemical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm perceptions of e-cigarettes and other nicotine products in a UK sample. Wilson, S., Partos, T., McNeill, A., et al.[2023]

In a study of 109 patients who struggled to quit smoking using e-cigarettes, only 5.5% managed to quit temporarily, highlighting the challenges of e-cigarette dependence.

However, after receiving pharmacological treatment and behavioral/cognitive training, 43.1% of participants successfully quit smoking, indicating that these interventions can significantly improve cessation rates for those who did not succeed with e-cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Behavioral and Pharmacological Smoking Cessation Treatment in Patients with Failed Attempt at Quitting with E-cigarettes. Duru Çetinkaya, P., Turan, A., Deniz, PP.[2021]

The study developed and validated 21 brief measures to assess various e-cigarette risk perceptions, including absolute health risks and risks compared to cigarettes and nicotine replacement therapy, based on a survey of 1,642 participants.

These measures demonstrated reliability and validity, showing that higher risk perceptions were linked to lower current e-cigarette use and greater intentions to quit, making them useful tools for public health research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Validating Measures of Absolute and Relative E-Cigarette Product Risk Perceptions: Single Items Can Be Surprisingly Comprehensive. O'Brien, EK., Baig, SA., Persoskie, A.[2022]

A meta-analysis of 18 studies involving 3756 papers found no significant difference in the rates of adverse events (AEs) like cough, oral irritation, and nausea between nicotine electronic cigarettes (ECs) and nicotine replacement therapies (NRTs).

The similar incidence of AEs suggests that the preference for nicotine ECs over NRTs is not driven by differences in adverse effects, indicating a need for further research to explore other factors influencing user choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. Anandan, AS., Leung, J., Chan, GCK., et al.[2023]

In a study involving 127 dual users of e-cigarettes, nicotine delivery was found to significantly reduce cravings for smoking, highlighting its role in the efficacy of e-cigarettes for smoking cessation.

Interestingly, participants using an altered sensorimotor apparatus reported greater craving reduction than those using normal e-cigarettes, suggesting that the sensory experience of vaping may be less critical for experienced users than previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinct influences of nicotine and sensorimotor stimuli on reducing cravings to smoke and vape among dual users. Palmer, AM., Sawyer, LE., Brandon, TH.[2022]

Many smokers overestimate the health risks of nicotine, believing it to be a major cause of smoking-related diseases, which affects their attitudes towards nicotine replacement therapy (NRT) and e-cigarettes.

Intervention messages aimed at correcting nicotine misperceptions successfully reduced the perceived harm of nicotine and significantly lowered the intention to use e-cigarettes, but did not impact attitudes towards NRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dilemma of Correcting Nicotine Misperceptions: Nicotine Replacement Therapy versus Electronic Cigarettes. Shi, R., Feldman, R., Liu, J., et al.[2022]

In a study of 35 adult daily smokers, the availability of e-cigarettes led to a significant 37% reduction in daily cigarette consumption, regardless of the nicotine content in the e-cigarettes.

Nicotine-containing e-cigarette cartridges resulted in greater usage and reduced cravings compared to non-nicotine cartridges, suggesting that while e-cigarettes can help reduce smoking, higher nicotine levels may enhance their appeal and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Short-Term Uptake of Electronic Cigarettes: Effects of Nicotine, Subjective Effects, and Simulated Demand. Tucker, MR., Laugesen, M., Bullen, C., et al.[2019]

In a study of 726 young adults, those who exclusively used e-cigarettes felt more confident about quitting compared to those who used both e-cigarettes and other tobacco products, indicating different motivations and perceptions about quitting.

Participants identified social influences, stress, and withdrawal symptoms as major barriers to quitting, highlighting the need for tailored cessation interventions that address these challenges and improve risk perceptions about tobacco use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette cessation interest and quit attempts among young adults reporting exclusive e-cigarette use or dual use with other tobacco products: How can we reach them? Le, D., Ciceron, AC., Romm, KF., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatments for smokers. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Current approaches to the management of smoking cessation. [2018]

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

Smoking cessation products and programs. [2007]

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

Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Harm perceptions of e-cigarettes and other nicotine products in a UK sample. [2023]

8. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of Behavioral and Pharmacological Smoking Cessation Treatment in Patients with Failed Attempt at Quitting with E-cigarettes. [2021]

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

Developing and Validating Measures of Absolute and Relative E-Cigarette Product Risk Perceptions: Single Items Can Be Surprisingly Comprehensive. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Distinct influences of nicotine and sensorimotor stimuli on reducing cravings to smoke and vape among dual users. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The Dilemma of Correcting Nicotine Misperceptions: Nicotine Replacement Therapy versus Electronic Cigarettes. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Predicting Short-Term Uptake of Electronic Cigarettes: Effects of Nicotine, Subjective Effects, and Simulated Demand. [2019]

14. Greece pubmed.ncbi.nlm.nih.gov

E-cigarette cessation interest and quit attempts among young adults reporting exclusive e-cigarette use or dual use with other tobacco products: How can we reach them? [2023]