Nicotine Product Claims for Risky Behaviors

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Age < 18 or > 65, ONPs use, others

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

Compensation: Varies

Number of Visits: 1

450 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for reducing risky behaviors associated with nicotine use?

Research on very low nicotine content (VLNC) cigarettes shows that smokers using these cigarettes had lower cigarette use and dependence compared to those using regular cigarettes. This suggests that reducing nicotine content can help decrease smoking-related risky behaviors. ^{1 2 3 4 5}

Is there any safety data available for nicotine products used in clinical trials?

The studies suggest that smokers adjust their behavior based on the nicotine yield of cigarettes, which affects their exposure to nicotine and carbon monoxide. This indicates that while nicotine intake can vary, the safety of nicotine products may depend on individual smoking behaviors and the type of product used. ^{1 3 6 7 8}

How does this treatment differ from other treatments for risky behaviors related to nicotine use?

This treatment is unique because it focuses on the claims of nicotine products and their impact on risky behaviors, rather than just the nicotine content itself. It considers the behavioral regulation and compensation that smokers exhibit, which is not typically addressed in standard nicotine addiction treatments. ^{1 3 9 10 11}

Research Team

Darren Mays, MPH, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 18-65 who either use tobacco products or are young adults (18-24) at risk of starting. Tobacco users must have used combustible, non-combustible, or both types of tobacco regularly for the past 6 months. Non-users should be open to using tobacco but haven't started yet. All participants must be able to visit the lab in person.

Inclusion Criteria

I am a tobacco user aged 18-65 and have never used oral nicotine products.

I have been using tobacco products regularly for at least 6 months.

I am 18-24, never used oral nicotine products, and might try smoking or chewing tobacco.

Exclusion Criteria

Unwilling or unable to complete an in-person lab visit

I am younger than 18 or older than 65.

Not susceptible non-users or current tobacco users

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Session

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental session

1-2 weeks

Treatment Details

Interventions

• 3x3 between-subjects experimental exposure

Trial Overview The study is examining how claims about nicotine products influence their appeal and perceptions among young adult non-users susceptible to smoking and adult smokers. It's a controlled experiment where participants are exposed to different product claims in a lab setting.

Participant Groups

Group I: Nicotine Concentration: None Displayed; Nicotine Source Claim 3 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group II: Nicotine Concentration: None Displayed; Nicotine Source Claim 2 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group III: Nicotine Concentration: None Displayed; Nicotine Source Claim 1 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group IV: Nicotine Concentration: Low; Nicotine Source Claim 3 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group V: Nicotine Concentration: Low; Nicotine Source Claim 2 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group VI: Nicotine Concentration: Low; Nicotine Source Claim 1 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group VII: Nicotine Concentration: High; Nicotine Source Claim 3 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group VIII: Nicotine Concentration: High; Nicotine Source Claim 2 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Group IX: Nicotine Concentration: High; Nicotine Source Claim 1 Experimental Treatment 1 Intervention

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

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

In a study of 865 smokers, it was found that the actual nicotine intake per cigarette was lower than what Federal Trade Commission (FTC) standards suggested, indicating that FTC nicotine yields are not reliable predictors of actual nicotine consumption.

The research showed that smokers adjust their behavior based on the nicotine yield of the cigarettes they smoke, leading to significant variations in individual smoking habits, which suggests that a simpler classification of cigarettes into broad categories would be more useful for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analytical cigarette yields as predictors of smoke bioavailability. Gori, GB., Lynch, CJ.[2019]

Randomized clinical trials of very low nicotine content (VLNC) cigarettes showed that participants using VLNC had significantly lower cigarette use, dependence, and exposure to harmful substances compared to those using normal nicotine cigarettes.

The analysis of these trials using causal inference methods, which account for non-adherence to treatment, provides important insights into the potential regulatory effects of implementing a nicotine standard for cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Estimating Causal Effects for Evaluating a Nicotine Standard for Cigarettes. Koopmeiners, JS., Vock, DM., Boatman, JA., et al.[2023]

Smokers who switched to ultra-low yield cigarettes (0.1 mg nicotine) showed significantly lower levels of cotinine and carbon monoxide after 5 days compared to those smoking high-yield cigarettes, indicating reduced biological exposure to harmful smoke constituents.

Despite the lower yields, smokers compensated by smoking more cigarettes and taking larger, more frequent puffs, suggesting that lower-yield cigarettes may not effectively reduce overall tobacco consumption or exposure to harmful substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette brand-switching: effects on smoke exposure and smoking behavior. Zacny, JP., Stitzer, ML.[2022]

New nicotine delivery systems, including a nasal spray and inhaler, have been shown to effectively reduce cravings and withdrawal symptoms, leading to improved cessation rates compared to placebo.

Nicotine replacement therapies like patches and gum are now available over-the-counter, and new safety data suggest they pose little additional risk for high-risk groups such as adolescents, pregnant women, and individuals with serious cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in approaches to smoking cessation. Jorenby, DE.[2019]

In a study of 1,484 adults, the absence of modified risk tobacco product (MRTP) claims led to a higher likelihood of trying tobacco products, lower concerns about serious diseases, and perceptions of lower addictiveness, particularly for low-nicotine products.

Participants viewed low-nicotine products, especially the JUUL e-cigarette without an MRTP claim, as less addictive and more likely to help with quitting smoking, highlighting the need for regulatory considerations regarding how MRTP claims affect consumer perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Modified Tobacco Risk Products with Claims and Nicotine Features on Perceptions among Racial and Ethnic Groups. DeAtley, T., Johnson, AC., Stone, MD., et al.[2023]

Habitual smokers consumed an average of 35 mg of nicotine from their usual cigarettes, while intake dropped to 26 mg when smoking high- or low-yield commercial cigarettes, indicating that smokers adjust their behavior to maintain nicotine levels.

Smokers obtained 60% more nicotine per cigarette than the Federal Trade Commission (FTC) yield predictions and smoked 25% more cigarettes per day, suggesting that current FTC yield measures may underestimate actual nicotine intake and associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine and carbon monoxide intake from high- and low-yield cigarettes. Benowitz, NL., Jacob, P.[2023]

A study involving 5478 college students in Texas found that exposure to electronic nicotine delivery system (ENDS) marketing significantly predicted increased ENDS use over time, indicating that marketing influences young adults' vaping behaviors.

Conversely, young adults who used ENDS were also more likely to report exposure to ENDS marketing in subsequent surveys, suggesting a bidirectional relationship between marketing exposure and ENDS use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional associations between young adults' reported exposure to e-cigarette marketing and e-cigarette use. Kreitzberg, DS., Pasch, KE., Marti, CN., et al.[2023]

A study involving 50 subjects found that over 60% of smokers using very low nicotine content (VLNC) cigarettes were noncompliant, often supplementing with regular cigarettes, which raises concerns about the effectiveness of nicotine reduction strategies.

Biomarker analysis using plasma cotinine levels provided a reliable method to assess compliance, highlighting the need for better monitoring in clinical trials to accurately evaluate the impact of reduced nicotine cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes. Benowitz, NL., Nardone, N., Hatsukami, DK., et al.[2022]

Users of high-nicotine/tar-yield cigarettes have a significantly greater risk of developing nicotine dependence compared to those who use lower-nicotine/tar-yield cigarettes, even after accounting for various sociodemographic factors.

This increased risk of dependence was consistent across different definitions of nicotine dependence and was observed in both adult and adolescent smokers, highlighting the need for further research on the implications of marketing and availability of these high-yield cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of High-Nicotine/Tar-Yield (Full-Flavor) Cigarettes and Risk for Nicotine Dependence in Nationally Representative Samples of US Smokers. Redner, R., White, TJ., Bunn, JY., et al.[2022]

In a review of tobacco advertisements from 1998 to 2002, only 1% were for new 'safe' cigarettes and nicotine delivery devices, indicating limited promotion of these products in popular media.

A survey of 113 small stores revealed that only 4.4% sold these reduced exposure products (PREPs), suggesting that the tobacco industry is not yet significantly marketing or distributing these potentially less harmful options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary investigation of the advertising and availability of PREPs, the new "safe" tobacco products. Hickman, N., Klonoff, EA., Landrine, H., et al.[2023]

In a study involving 169 smokers from vulnerable populations, the modified Cigarette Evaluation Questionnaire (mCEQ) effectively predicted preferences for higher nicotine content cigarettes, particularly through its Satisfaction and Enjoyment of Respiratory Tract Sensations subscales.

The Cigarette Purchase Task (CPT) also provided predictive insights, but its effectiveness varied by nicotine dose, especially among opioid-maintained individuals, highlighting the complexity of nicotine's reinforcing effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the utility of the modified cigarette evaluation questionnaire and cigarette purchase task for predicting acute relative reinforcing efficacy of cigarettes varying in nicotine content. Bergeria, CL., Heil, SH., Davis, DR., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Analytical cigarette yields as predictors of smoke bioavailability. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The Importance of Estimating Causal Effects for Evaluating a Nicotine Standard for Cigarettes. [2023]

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

Cigarette brand-switching: effects on smoke exposure and smoking behavior. [2022]

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

New developments in approaches to smoking cessation. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Modified Tobacco Risk Products with Claims and Nicotine Features on Perceptions among Racial and Ethnic Groups. [2023]

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

Nicotine and carbon monoxide intake from high- and low-yield cigarettes. [2023]

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

Bidirectional associations between young adults' reported exposure to e-cigarette marketing and e-cigarette use. [2023]

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

Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes. [2022]

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

Use of High-Nicotine/Tar-Yield (Full-Flavor) Cigarettes and Risk for Nicotine Dependence in Nationally Representative Samples of US Smokers. [2022]

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

Preliminary investigation of the advertising and availability of PREPs, the new "safe" tobacco products. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Evaluating the utility of the modified cigarette evaluation questionnaire and cigarette purchase task for predicting acute relative reinforcing efficacy of cigarettes varying in nicotine content. [2023]