What side effects are associated with this type of intervention?

Common treatments for smoking cessation include nicotine replacement therapy (NRT), bupropion, varenicline, and behavioral interventions like cognitive-behavioral therapy (CBT) and motivational interviewing. NRT can cause side effects such as nasal irritation, burning, and taste disturbances. Bupropion may lead to insomnia, dry mouth, and potential cardiovascular issues. Varenicline is associated with nausea, vomiting, and in some cases, neuropsychiatric symptoms. Behavioral interventions generally have minimal physical side effects but may require significant time and effort from the patient.

What prior FDA approvals exist?

The FDA has approved several treatments for smoking cessation, including nicotine replacement therapy (NRT), bupropion, and varenicline. These pharmacological treatments are often used in conjunction with behavioral interventions such as motivational interviewing and cognitive-behavioral therapy. The Health Consequence Messages trial, which focuses on behavioral change through emotional and cognitive framing, aligns with these behavioral interventions to enhance smoking cessation efforts.

What other types of research exist?

Promising novel alternatives to health consequence messages for smoking cessation in 2024 include: 1) Mobile phone text messaging and app-based interventions, which have shown effectiveness in supporting smoking cessation. 2) Internet-based interventions, which provide accessible and scalable support for quitting smoking. 3) Social network interventions, such as those using platforms like Facebook and Twitter, which leverage peer support and community engagement. 4) Cognitive-behavioral therapy (CBT) approaches, which address the psychological aspects of addiction and can be delivered digitally or in person.

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Health Literacy Interventions for Smoking

N/A

Waitlist Available

Led By Lorna H. McNeill, MPH,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current smoker with a history of at least 5 cigarettes/day for the last year

Age 18 to 70 years

Must not have

Current use of nicotine replacement therapy or bupropion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining whether different types of messages emphasizing the health consequences of smoking, written at a 5th to 6th grade reading level, will have different effects on smokers with varying levels of health literacy.

Who is the study for?

This trial is for English-speaking smokers aged 18 to 70 who have smoked at least 5 cigarettes daily over the past year. They must have a home address, phone number, and not be using nicotine replacements or enrolled in cessation programs.

What is being tested?

The study tests how different types of messages about smoking risks affect smokers' intentions to quit and their attitudes towards smoking. It uses audio scripts with matching text that vary by emotionality (fact-based vs. emotional) and framing (benefits of quitting vs. costs of not quitting).

What are the potential side effects?

Since this trial involves listening to messages and answering questionnaires, there are no direct physical side effects associated with medical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I currently smoke at least 5 cigarettes a day and have been doing so for the last year.

Select...

I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using nicotine replacement therapy or bupropion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Factors that may influence how smokers understand smoking health risk informational messages.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Factual Loss-FramedExperimental Treatment2 Interventions

Smoking Risk Message - Factual Loss-Framed (FLF)

Group II: Factual Gain-FramedExperimental Treatment2 Interventions

Smoking Risk Message - Factual Gain-Framed (FGF)

Group III: Emotional Loss-FramedExperimental Treatment2 Interventions

Smoking Risk Message - Emotional Loss-Framed (ELF)

Group IV: Emotional Gain-FramedExperimental Treatment2 Interventions

Smoking Risk Message - Emotional Gain-Framed (EGF)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focus Group

2017

Completed Phase 1

~4710

Questionnaire

2014

Completed Phase 2

~19970

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for smoking cessation include behavioral interventions, pharmacotherapy, and combined approaches. Behavioral interventions, such as cognitive-behavioral therapy (CBT) and motivational interviewing (MI), work by altering the smoker's thought patterns and behaviors related to smoking. Emotional and cognitive framing, as studied in the Health Consequence Messages trial, uses fact-based and emotion-based messages to influence smokers' attitudes and intentions to quit. This approach matters because it can effectively target smokers' motivations and barriers, making the cessation process more personalized and potentially more successful. Pharmacotherapy, including nicotine replacement therapy (NRT) and medications like varenicline, helps reduce withdrawal symptoms and cravings, supporting the smoker's efforts to quit. Combining these methods often yields the best results, addressing both the psychological and physiological aspects of nicotine addiction.

Mindfulness-Based Smoking Cessation Delivered Through Telehealth and Text Messaging for Low-Income Smokers: Protocol for a Randomized Controlled Trial.Informing Tobacco Cessation Benefit Use Interventions for Unionized Blue-Collar Workers: A Mixed-Methods Reasoned Action Approach.Computer-tailored smoking cessation materials: a review and discussion.