Promotion Factors + Mitigation Strategies for Smoking Behavior

Overseen By Warren Bickel, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Tobacco cessation, Nicotine metabolism

Disqualifiers: Pregnancy, Serious health condition, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different strategies influence tobacco-buying behaviors among users. Specifically, it examines both legal and illegal purchases by those who either smoke cigarettes exclusively or use both cigarettes and nicotine vaping products. Participants should have stable smoking habits, smoking at least 10 cigarettes daily, and either avoid regular vaping or use vapes multiple times a week. Those interested in joining should not plan to quit or change their tobacco use during the study.

As an unphased trial, this study offers participants a unique opportunity to contribute to understanding tobacco use behaviors without the pressure of treatment changes.

Will I have to stop taking my current medications?

If you are taking a tobacco cessation medication or a medication that affects nicotine metabolism, motivation, or reinforcement, you cannot participate in this trial.

What prior data suggests that these mitigation strategies and promotion factors are safe for tobacco users?

Research shows that methods to help people quit smoking, such as counseling and nicotine replacement therapies (NRTs), are generally safe and well-tolerated. Studies have found that these methods effectively control cravings and reduce withdrawal symptoms without major safety issues. For instance, NRTs deliver a small, steady amount of nicotine to ease withdrawal and are widely used and considered safe. Common side effects might include mild skin irritation from patches or slight throat irritation from lozenges, but serious problems are rare.

Promotion strategies often involve educational programs or media messages that influence smoking behavior. Research suggests these strategies are safe because they focus on communication rather than physical treatments. They aim to change smoking habits by raising awareness and are generally considered safe.

Overall, evidence supports the safety of both the methods to help quit smoking and the promotion strategies used in this study for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a combination of promotion factors and mitigation strategies to address smoking behavior, a fresh approach compared to traditional methods like nicotine replacement therapy or prescription medications. Unlike typical treatments that often focus solely on nicotine reduction, this trial considers both the physiological and behavioral aspects of smoking. By targeting dual users of cigarettes and nicotine vaping products as well as exclusive cigarette smokers, the trial hopes to uncover insights into how different strategies can influence smoking habits and potentially lead to more effective interventions. This comprehensive approach could lead to more personalized and successful quit-smoking programs in the future.

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

This trial will explore different strategies to help individuals quit smoking. Research has shown that combining methods effectively aids smoking cessation. Counseling and medication work well together, making it easier to stop smoking. Support from family encourages participants to attempt quitting more often and smoke less. Health programs that include education and rewards also effectively assist people in quitting. Overall, a mix of support and educational activities increases the chances of successfully quitting smoking. Participants in this trial will be divided into two groups: dual cigarette/nicotine vaping product users and exclusive cigarette smokers, each exposed to various conditions to assess the effectiveness of these strategies. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who smoke at least 10 cigarettes daily or use both cigarettes and nicotine vapor products (NVPs). Participants must not be planning to quit smoking, move away, take tobacco cessation meds, or have serious health issues. Pregnant or lactating individuals are excluded.

Inclusion Criteria

Provide informed consent

Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)

Stable tobacco use patterns for at least two months

Exclusion Criteria

Have plans to move out of the area

Being pregnant or lactating

I do not have any serious or unstable health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Phase

Participants are exposed to various conditions in the Illegal Experimental Tobacco Marketplace (iETM) to study promotion and mitigation factors affecting tobacco purchases

8 weeks

Follow-up

Participants are monitored for changes in purchasing behavior and response to intervention conditions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitigation strategies
• Promotion factors

Trial Overview The study examines how certain factors encourage legal and illegal tobacco purchases and the effectiveness of strategies designed to reduce these purchases among different types of tobacco users.

How Is the Trial Designed?

Group I: Experimental: Exclusive cigarette smokers Experimental Treatment 2 Interventions

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Group II: Experimental: Dual cigarette/ nicotine vaping product users Experimental Treatment 2 Interventions

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

The effectiveness of smoking cessation programs is strongly linked to the positive reinforcement smokers receive for abstaining from smoking, suggesting that encouragement plays a crucial role in their success.

The outlined program is designed to be efficient for physicians, requiring minimal time commitment while providing a self-sustaining support system for smokers who wish to quit, making it a rewarding experience for both parties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation strategies and evaluation. Kottke, TE., Solberg, LI., Brekke, ML., et al.[2019]

A literature review of 50 studies identified both nonpreventable factors (like sociodemographics) and preventable factors (such as forgetfulness) that contribute to nonadherence to smoking cessation medications, highlighting the complexity of adherence issues.

The review emphasizes the need for standardized definitions and objective measures of adherence, as well as more research focused on vulnerable populations, to improve the effectiveness of smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pharmacological Smoking Cessation Interventions: A Literature Review and Synthesis of Correlates and Barriers. Pacek, LR., McClernon, FJ., Bosworth, HB.[2023]

Physicians play a vital role in reducing smoking rates through both individual counseling and broader public health initiatives, which together enhance the effectiveness of smoking cessation efforts.

By providing brief clinical counseling and referring patients to established quit programs, physicians can significantly support their smoking patients in their journey to quit, addressing the challenges posed by the addictive nature of tobacco.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: a practical guide for the physician. Fisher, EB., Rost, K.[2017]

The paper outlines 19 distinct approaches to tobacco harm reduction, categorizing them based on 11 dimensions such as objectives, mechanisms, and expected risks, which helps clarify the diverse strategies available.

It also specifically analyzes nine applications of medicinal nicotine in smoking interventions, highlighting new methods for reducing tobacco-related harm and promoting clearer discussions in tobacco control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco harm reduction: conceptual structure and nomenclature for analysis and research. Shiffman, S., Gitchell, JG., Warner, KE., et al.[2022]

A study involving 292 young adult smokers in New Zealand found that plain cigarette packaging with large graphic health warnings significantly reduced the appeal of smoking and promoted cessation-related behaviors compared to branded packs.

Smokers were less likely to choose options with fewer branding elements or larger health warnings, indicating that plain packaging could effectively encourage quitting smoking by making cigarettes less attractive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dissuasive packaging on young adult smokers. Hoek, J., Wong, C., Gendall, P., et al.[2021]

A systematic review of 40 studies found no significant benefit of specific relapse prevention interventions for recent quitters, indicating that these strategies may not effectively reduce smoking relapse rates.

The evidence suggests that it may be more effective to concentrate on supporting initial quit attempts rather than investing in relapse prevention interventions, as current methods have not shown clear advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapse prevention interventions for smoking cessation. Hajek, P., Stead, LF., West, R., et al.[2018]

There is potential to reduce health risks for smokers by developing cigarettes that remove toxic components and lower overall smoke intake, which could lead to a decrease in disease incidence over time.

While these modified cigarettes may not taste the same as traditional ones, changing consumer perceptions and adding compensating flavors could encourage smokers to switch, ultimately aiming to reduce smoking-related health issues significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-risk cigarettes: a prescription. Gori, GB.[2023]

The health risks of smoking are influenced by the type of substance smoked, how often it is smoked, and the way it is consumed, highlighting the need for a comprehensive assessment in treatment.

A new approach called controlled smoking is suggested, which focuses on personalized goals and skill development to help reduce smoking risks, recognizing that different individuals may respond differently to smoking behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled smoking. Frederiksen, LW.[2017]

In a study involving 703 U.S. adult smokers, effects perceptions (how individuals believe the messages will impact their behavior) were found to be a significant mediator for the effectiveness of tobacco risk messages, influencing quit intentions and smoking-related behaviors.

Message perceptions (how persuasive the messages are perceived to be) did not show any independent effect on the outcomes, highlighting the importance of focusing on effects perceptions when designing tobacco risk messages for better behavioral impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Message perceptions and effects perceptions as proxies for behavioral impact in the context of anti-smoking messages. Baig, SA., Noar, SM., Gottfredson, NC., et al.[2021]

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]

The article outlines the use of behavioral science theory and formative research to create effective television and radio campaigns aimed at preventing adolescents from starting to smoke cigarettes.

It details the content and structure of the anti-smoking messages, as well as the planning and costs associated with implementing these campaigns on a national scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three mass media campaigns to prevent adolescent cigarette smoking. Bauman, KE., Brown, JD., Bryan, ES., et al.[2022]

In a study of 135 female smokers of reproductive age, gain-framed messages about the benefits of quitting smoking were rated significantly more effective than loss-framed messages focused on the risks of smoking, suggesting a more positive approach may motivate cessation.

The findings indicate that positively framed health messages can be a promising strategy to encourage smoking cessation among women, particularly during pregnancy, by enhancing their confidence in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framing pregnancy-related smoking cessation messages for women of reproductive age. Klein, EG., Macisco, J., Lazard, A., et al.[2023]

In a study involving 60 chronic smokers, exposure to different smoking-related cues (environmental and negative affect) significantly influenced their desire to smoke and how they smoked during a 20-minute observation period.

The findings suggest that both types of cues play a crucial role in maintaining smoking behavior, highlighting the importance of understanding cue reactivity in smoking addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to smoking-relevant cues: effects on desire to smoke and topographical components of smoking behavior. Payne, TJ., Schare, ML., Levis, DJ., et al.[2019]

In a survey of 471 students in grades 6-12, 36.1% showed susceptibility to smoking, with strong positive expectations about smoking (like enjoyment) significantly increasing this likelihood (OR = 29.4).

Negative expectations about smoking had a weaker impact on susceptibility, indicating that simply teaching about the risks of smoking may not effectively deter adolescents; instead, programs should focus on addressing the positive beliefs teens have about smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative outcome expectations of smoking: implications for prevention. Dalton, MA., Sargent, JD., Beach, ML., et al.[2017]

Integrating self-efficacy and response efficacy messages into the packaging of roll-your-own tobacco may lead to more positive emotional responses and beliefs about quitting compared to standard Quitline information, based on a study involving 785 participants.

This approach could serve as an effective micro-intervention at the point of decision-making for smokers, particularly benefiting those with high motivation to quit, thereby enhancing the impact of existing pictorial warning labels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roll-your-own smokers' reactions to cessation-efficacy messaging integrated into tobacco packaging design: a sequential mixed-methods study. Blank, ML., Hoek, J., Gendall, P.[2020]

Citations

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Effectiveness of family-based behavioral intervention for ... Parents receiving family-based behavioral interventions showed greater reductions in daily cigarette consumption, increased quit attempts, ...

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Smoking Cessation Interventions Clinical studies have demonstrated that combining pharmacotherapy with effective behavior strategies is significantly more effective than either approach alone.

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Evidence base and strategies for successful smoking ... There are at least three mechanisms by which NRTs can aid smoking cessation efforts; first, physical withdrawal symptoms may be reduced, NRTs may also reduce ...

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How to quit smoking: Top 3 efficient strategies from recent ... The cohort reported moderate-certainty evidence that counselling, cost-free cessation medicines, and tailored reading materials correlate with ...

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Interventions for Tobacco Smoking Cessation in Adults ... The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and FDA- ...