Smoking Cessation Program for Caregivers Who Smoke

Overseen By Brian Williams, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must be taking: Nicotine replacement

Must not be taking: Bupropion, Varenicline

Disqualifiers: Pregnancy, Recent myocardial infarction, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smoking cessation program can help caregivers of hospitalized children reduce or quit smoking. Participants will complete a survey about their smoking habits, receive a 20-minute counseling session, and use nicotine patches and mini-lozenges (types of Nicotine Replacement Therapy) for two weeks. The goal is to determine if caregivers find this program helpful and if it should be implemented more widely in hospitals. This trial suits caregivers who smoke at least five cigarettes a day and have a child staying in the hospital for more than 24 hours. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients, offering caregivers a proven method to quit smoking.

Do I have to stop taking my current medications?

The trial requires you to stop using any current smoking cessation medications like nicotine replacement therapy (NRT), bupropion, or varenicline.

What is the safety track record for these treatments?

Previous studies have shown that nicotine replacement therapies (NRTs), such as patches and lozenges, are safe and well-tolerated by adults who smoke. Research indicates that these products help manage cravings and withdrawal symptoms by providing a nicotine effect similar to what smokers are accustomed to. The Centers for Disease Control and Prevention (CDC) states that NRTs are safe and effective for helping people quit smoking. The FDA has approved these products, which can double the chances of successfully quitting smoking. Using a patch along with lozenges often proves more effective than using the patch alone. These findings suggest that the treatment offered in this trial is generally safe for participants. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the nicotine replacement product being studied because it specifically targets caregivers of hospitalized children, a group that may have unique stressors influencing their smoking habits. Unlike standard nicotine replacement therapies, such as patches or gum, this approach is tailored to provide support within a high-stress caregiving environment, potentially increasing its effectiveness. The focus on this specific group could lead to better cessation outcomes by addressing their particular needs and challenges, which are often overlooked by more generalized smoking cessation programs.

What evidence suggests that this smoking cessation program is effective for caregivers?

Research has shown that nicotine replacement products, such as patches and lozenges, can significantly aid in quitting smoking. In this trial, caregivers of hospitalized children will have access to these products. They provide a controlled amount of nicotine to ease cravings and withdrawal symptoms, making it easier to reduce or stop smoking. Studies suggest that using these products can more than double the chances of successfully quitting smoking. Additionally, combining nicotine replacement with counseling has proven effective, even for those not initially planning to quit. Overall, nicotine replacement therapy is a proven method for quitting smoking and can be a helpful part of a plan to stop smoking. ^{1 6 7 8 9}

Who Is on the Research Team?

Brian Williams, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for caregivers over 18 who smoke at least 5 cigarettes a day and have a child admitted to the hospital for more than 24 hours. They must be the primary caregiver, not pregnant or breastfeeding, willing to use birth control, and able to commit to the study's duration without needing an interpreter.

Inclusion Criteria

Someone in my household smokes.

My child will be in the hospital for more than a day.

I am the main person taking care of my hospitalized child.

Exclusion Criteria

Caregiver's child is being cared for by study physician (Dr. Brian Williams)

You had a bad reaction to the nicotine patch or mini-lozenge in the past that made it impossible for you to keep using it.

I need an interpreter for communication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Counseling and Treatment

Participants complete a survey, undergo a 20-minute counseling session, and receive a 2-week supply of nicotine patches and mini-lozenges

2 weeks

1 visit (in-person)

Post-Intervention Follow-up

Participants are contacted within 24 hours of discharge to complete a post-intervention survey assessing NRT use and smoking behavior during hospitalization

1 week

Follow-up

Participants are contacted 2 weeks after discharge to complete a follow-up survey assessing smoking status, NRT use, and interest in ongoing treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Replacement Product

Trial Overview

The study tests if caregivers will engage in a smoking cessation program during their child's hospital stay. It includes completing surveys, undergoing counseling sessions, and using nicotine patches and lozenges for two weeks.

How Is the Trial Designed?

Group I: Caregivers of hospitalized children Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

A study analyzing data from 10,860 users over 269,837 days found that the combination of azelastine-fluticasone resulted in significantly lower allergy symptoms compared to other treatments, while oral corticosteroids were associated with higher symptoms.

Allergen immunotherapy (AIT) was linked to a reduction in allergy symptoms, particularly when compared to no treatment, highlighting its potential effectiveness in managing allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of rhinitis treatments using MASK-air® data and considering the minimal important difference. Sousa-Pinto, B., Schünemann, HJ., Sá-Sousa, A., et al.[2023]

Nicotine replacement therapy (NRT) has been shown to be effective in treating tobacco addiction, with various forms (gum, patch, nasal spray, etc.) demonstrating efficacy rates between 1.5 to 3.6 based on usage conditions and application methods across approximately 132 clinical trials.

NRT is generally safe and available over-the-counter, except for the nicotine nasal spray, and its effectiveness can be improved by ensuring the right form, dosage, and adherence to treatment guidelines for individual users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking cessation with nicotine replacement therapy (NRT) - a scientific update]. Mulzer, KH., Lichtenschopf, A., Homeier, I., et al.[2021]

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

In a study involving 142 women with cardiovascular disease, only 9% to 22% reported using nicotine replacement therapy (NRT) during follow-up, indicating a low utilization rate despite its recommendation in a nurse-managed smoking cessation program.

The findings suggest a need for further research to address misconceptions about NRT among women, as nurses can play a crucial role in educating patients to help prevent smoking relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Initiative for Nonsmoking (WINS V): under-use of nicotine replacement therapy. Mahrer-Imhof, R., Froelicher, ES., Li, WW., et al.[2019]

Ragweed sublingual immunotherapy tablets (SLIT-T) significantly reduced allergy symptoms in Canadian subjects, with a 26% reduction in total combined score (TCS) for the 6 Amb a 1-U dose and a 40% reduction for the 12 Amb a 1-U dose during peak ragweed season.

The treatment was well tolerated, with mostly mild to moderate adverse events and no serious allergic reactions, indicating a favorable safety profile for this new form of immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Kim, H., Waserman, S., Hébert, J., et al.[2020]

A study analyzing 98 reported adverse reactions to sublingual immunotherapy (SLIT) drugs in Japan found that 97.7% of cases showed recovery or improvement, indicating a generally favorable safety profile.

The most common adverse event was anaphylaxis (42.6%), particularly in pediatric and adolescent patients, highlighting the need for careful monitoring during the initial treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Sublingual Immunotherapy: A Secondary Analysis of Post-marketing Adverse Events Reports Using a Japanese Public Database. Kaneda, Y., Kaneda, U., Namba, M., et al.[2023]

Nicotine replacement therapy (NRT) significantly increases the chances of quitting smoking by 50% to 60%, based on a systematic review of 136 studies involving 64,640 participants, demonstrating its effectiveness across various forms like gum, patches, and sprays.

While NRT can cause minor side effects such as skin irritation and mouth discomfort, serious adverse events are extremely rare, indicating that NRT is a safe option for those trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy versus control for smoking cessation. Hartmann-Boyce, J., Chepkin, SC., Ye, W., et al.[2022]

Nicotine replacement therapy (NRT) significantly increases the chances of quitting smoking, with an odds ratio of 1.72 compared to control, and is effective across various forms including gum, patches, and nasal sprays, regardless of the level of additional support provided.

While all forms of NRT are effective, the study suggests that bupropion may be more effective than NRT alone or in combination, indicating that alternative pharmacotherapies could enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy for smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2018]

Nicotine replacement therapy (NRT) is an effective strategy for habitual smokers with nicotine dependence who are trying to quit smoking.

NRT provides a helpful measure by delivering controlled doses of nicotine to reduce withdrawal symptoms and cravings, making it easier for individuals to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy]. Handa, S.[2015]

Recent updates indicate that allergen-specific immunotherapy (ASIT), particularly sublingual immunotherapy (SLIT), is generally safe, with no reported deaths from subcutaneous immunotherapy or SLIT in the last two years.

However, systemic reactions can still occur, often due to administration errors, highlighting the importance of understanding patient-specific risk factors and adhering to new Clinical Practice Guidelines to enhance safety in ASIT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for systemic reactions to allergen immunotherapy. Iglesias-Cadarso, A., Hernández-Weigand, P.[2011]

The study found that three prototype 4-mg nicotine lozenges produced in India were bioequivalent to the globally marketed Nicorette® 4-mg lozenge, indicating they can effectively deliver similar levels of nicotine to the bloodstream.

All prototype lozenges were well tolerated and had safety profiles comparable to the reference product, suggesting they are a safe alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . Sukhija, M., Srivastava, R., Kaushik, A.[2018]

In a study of 84,667 patients in a smoking cessation program, it was found that the prescribed doses of nicotine replacement therapy (NRT) did not increase adequately with the number of cigarettes smoked per day, leading to potential under-treatment.

Patients who received initial NRT doses below 2 mg per cigarette per day had poorer cessation outcomes, suggesting that higher doses may be necessary for heavy smokers to improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. Veldhuizen, S., Behal, A., Zawertailo, L., et al.[2023]

In a study of 1563 children and adolescents undergoing allergen immunotherapy (AIT), only 1.53% experienced systemic reactions (SRs), indicating that AIT is generally safe in a real-life pediatric setting.

Risk factors for SRs included being polysensitized to pollen, using grass pollen extracts, and administering natural extracts instead of allergoids, with respiratory and skin symptoms being the most common reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): A paediatric assessment. Rodríguez Del Río, P., Vidal, C., Just, J., et al.[2022]

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There is evidence that concurrent use of the patch and an immediate-release NRT (e.g., inhaler, gum or lozenge) is more effective than the patch alone (Bohadana ...