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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand reactions to different nicotine products by examining participants' thoughts and feelings. Participants will view images of product packaging with varying nicotine levels and claims, then complete specific tasks and questionnaires. The trial suits young adults who have never used tobacco but might in the future, or adults who currently use tobacco but haven't tried new nicotine products recently. As an unphased trial, this study offers a unique opportunity to contribute to important research on nicotine perception and usage.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments with low nicotine levels are usually easy for people to handle. Studies indicate that using cigarettes with very low nicotine can lower nicotine intake and might help people quit smoking. However, smokers might inhale more smoke to get their usual nicotine amount, which is an unintended effect.

In contrast, high nicotine levels pose several health risks. Nicotine increases the chances of heart and lung issues and can be addictive. It may also cause problems like irritability, anxiety, and trouble sleeping.

For products without a listed nicotine level, people often think they are less risky. However, the effects of nicotine, such as addiction and its impact on mental health, still apply. It's important to consider these factors when evaluating the safety of nicotine-related products. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of nicotine product claims on risky behaviors, a relatively uncharted area compared to traditional treatments like nicotine replacement therapies or prescription medications for smoking cessation. This study uniquely examines how different nicotine concentrations and source claims on product packaging affect behavior, which could shed light on how marketing influences consumer decisions. By understanding these psychological and behavioral responses, researchers aim to develop more effective public health strategies and regulations to reduce risky behaviors associated with nicotine use.

What evidence suggests that this trial's treatments could be effective?

This trial will explore how different nicotine concentrations and source claims affect behavior. Research has shown that using products with low nicotine levels can help reduce nicotine dependence and aid in quitting smoking. Studies have found that switching to cigarettes with very low nicotine can lower exposure to harmful chemicals and decrease nicotine addiction.

Participants in this trial will encounter various nicotine concentrations, including low and high levels, as well as products without displayed nicotine levels. High nicotine levels can enhance thinking skills in smokers but also increase the risk of addiction and mood problems, particularly in young people. While nicotine can boost brain activity related to decision-making, starting young can lead to lifelong addiction.

For products without clear nicotine levels, effects can vary. Some research suggests nicotine can aid focus and memory, but these benefits are less certain for non-smokers. Overall, nicotine's effects largely depend on the amount used and the individual. ^{6 7 8 9 10}

Who Is on the Research Team?

Darren Mays, MPH, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

Not susceptible non-users or current tobacco users

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6018192/

Cognitive Effects of Nicotine: Recent Progress - PubMed Central For example, compared to healthy controls, cigarette smokers have cognitive deficits in auditory–verbal and visuospatial learning, visuospatial memory, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3543069/

Short- and Long-Term Consequences of Nicotine Exposure ... Nicotine exposure during adolescence alters acetylcholine and glutamate receptor signaling in the prefrontal cortex, one of the last brain areas to mature.

3. cdc.gov cdc.gov/mmwr/volumes/72/wr/mm7244a1.htm

Tobacco Product Use Among U.S. Middle and High School Abstract. Tobacco product use during adolescence increases the risk for lifelong nicotine addiction and adverse health consequences.

4. nature.com nature.com/articles/s41380-025-03110-0

Adolescent nicotine exposure and persistent neurocircuitry ... Nicotine use, and particularly nicotine use during adolescence is associated with an increased risk of addiction and mood disorders in adulthood ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432818310118

Risky decision-making is associated with impulsive action ... Nicotine is an addictive psychostimulant shown to enhance both locomotion and evoked dopamine release in the nucleus accumbens [33]. Furthermore ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4363846/

Harmful effects of nicotine - PMC - PubMed Central - NIH Nicotine poses several health hazards. There is an increased risk of cardiovascular, respiratory, gastrointestinal disorders.

7. cdc.gov cdc.gov/tobacco/e-cigarettes/health-effects.html

Health Effects of Vaping | Smoking and Tobacco Use Nicotine addiction and withdrawal · Feeling irritable, jumpy, restless, or anxious · Feeling sad or down · Having trouble sleeping · Having a hard ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/diseases/21582-nicotine-poisoning

Nicotine Poisoning: Symptoms, Causes, Treatment & ... Poisoning is more common in children due to their smaller size. Symptoms include vomiting, rapid heart rate, unsteadiness and increased salivation.

9. health.state.mn.us health.state.mn.us/communities/tobacco/nicotine/index.html

Commercial Tobacco Use Nicotine and ... Brain development: Nicotine can damage brain growth, making it harder to focus and learn. · Addiction risk: Teens can become addicted quickly, ...

10. globalheartjournal.com globalheartjournal.com/articles/10.5334/gh.1292

When Poison is Addictive – a WHF Policy Brief Numerous studies have demonstrated that nicotine can harm multiple organs, including the respiratory and cardiovascular systems.