Smoking Cessation Program for Quitting Smoking

Overseen By Roxana de Dios Despaux, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Disqualifiers: Current cigarette smoker

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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

608 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective program to help construction workers quit smoking by comparing different methods in terms of effectiveness, cost, and ease of use. Participants may receive support from a tobacco quit-line, brief counseling, or a combination of these with nicotine gum (Nicoderm C-Q Gum), depending on their group. The trial focuses on construction workers who have smoked at least five cigarettes daily for the past year and are ready to attempt quitting in the next 30 days. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

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 is the safety track record for these treatments?

Research shows that Nicoderm C-Q gum is generally safe. Studies have found that this nicotine replacement therapy (NRT) does not cause serious side effects or heart problems. For example, a large study with 3,094 participants found no connection between the gum and any major health issues.

The behavioral counseling used in the trial is also effective and safe. Brief counseling helps people quit smoking by providing strategies to manage cravings and avoid triggers. More intensive counseling, which includes additional sessions and support, improves the chances of quitting smoking when combined with NRT.

Overall, both Nicoderm C-Q gum and the counseling methods in this trial have been well-tolerated in past studies, with no major safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the combination of behavioral counseling with Nicoderm C-Q Gum, a form of nicotine replacement therapy, in innovative ways. Unlike traditional methods that might rely solely on counseling or nicotine patches, this trial offers a structured approach with multiple follow-ups and a tailored gum dosage based on smoking habits. This trial is particularly noteworthy because it tests how combining different types of support—like quit-line referrals, intensive counseling, and personalized nicotine gum—can improve long-term quitting success. By investigating these combinations, researchers hope to uncover more effective strategies for helping people quit smoking for good.

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

Research has shown that Nicoderm C-Q Gum, which participants in this trial may receive, can help people quit smoking. Studies indicate that nicotine replacement therapies (NRT), such as this gum, increase the likelihood of quitting. One study found that using NRT products significantly boosts the chances of quitting, with success rates ranging from 20% to 24% for different NRT types. Participants in this trial may also receive counseling support, which enhances the likelihood of quitting. Both short and detailed counseling sessions have proven effective by encouraging more quit attempts and reducing cigarette use. Combining Nicoderm C-Q Gum with counseling provides a strong method for quitting smoking. ^{3 6 7 8 9}

Who Is on the Research Team?

Taghrid Asfar, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for construction sector leaders and safety managers over 18, involved in decision-making or willing to deliver smoking cessation treatment. It's also for workers who smoke at least 5 cigarettes daily, are ready to quit soon, and plan to stay with the company. Safety managers can't be current smokers.

Inclusion Criteria

Be a safety manager

No plans to leave the company within the next year

Bilingual

Exclusion Criteria

Safety Managers: Current cigarette smoker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three groups: Tobacco Quit-line, Brief Behavioral Counseling, or Intensive Behavioral Counseling, and receive respective interventions

12 months

Follow-up

Participants are monitored for effectiveness, cost-effectiveness, and implementation outcomes

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Counseling
• Intensive Behavioral Counseling
• Nicoderm C-Q Gum
• Tobacco Quit-line

Trial Overview

The study tests different smoking cessation methods: intensive behavioral counseling, a tobacco quit-line service, brief counseling sessions, and Nicoderm C-Q Gum. The goal is to find the most effective program for helping construction workers quit smoking.

How Is the Trial Designed?

Group I: Phase 2 Group B: Second Brief Behavioral Counseling Group Experimental Treatment 3 Interventions

Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.

Group II: Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group Experimental Treatment 4 Interventions

Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.

Group III: Phase 2 Group A: Second Tobacco Quit-line (TQL) Group Experimental Treatment 1 Intervention

Participants from Group A who did not quit smoking at the 3-month follow-up may receive a second referral to the TQL and will be followed up for up to 12 months.

Group IV: Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group Experimental Treatment 3 Interventions

Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.

Group V: Phase 1 Group B: Brief Behavioral Counseling Group Experimental Treatment 3 Interventions

Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.

Group VI: Phase 1 Group A: Tobacco Quit-line (TQL) Group Experimental Treatment 1 Intervention

Participants will be referred to the TQL and will be followed up for up to 12 months.

Nicoderm C-Q Gum is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nicoderm CQ for:

• Smoking cessation

Approved in European Union as Nicoderm CQ for:

• Smoking cessation

Approved in Canada as Nicoderm CQ for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Published Research Related to This Trial

Nicotine-replacement products, particularly transdermal nicotine patches, are effective in alleviating withdrawal symptoms during smoking cessation, making them a promising option for smokers trying to quit.

A review of recent clinical trials indicates that transdermal patches have superior pharmacokinetics and fewer side effects compared to nicotine gum, suggesting they may be the preferred method for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine-replacement products in smoking cessation: a review. Alsagoff, F., Lee, HP.[2018]

In a study involving 118 volunteers in a smoking cessation program, the use of nicotine polacrilex (Nicorette) alongside behavioral support achieved a success rate of 40% to 47% for quitting smoking after one year, with results verified through chemical testing.

The regimen for using nicotine polacrilex in this study was effective and adhered to labeling guidelines, although it differed significantly from typical protocols used in other smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stop-smoking program using nicotine reduction therapy and behavior modification for heavy smokers. Cooper, TM., Clayton, RR.[2019]

In a study involving 24 male smokers, the Nicoderm nicotine patch delivered significantly higher plasma nicotine concentrations compared to the Habitrol patch, especially in the first 8 hours after application.

Both patches had similar safety profiles, with no significant difference in the incidence of adverse events, but they were not bioequivalent, indicating that Nicoderm may provide a more effective nicotine delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. Gupta, SK., Okerholm, RA., Eller, M., et al.[2019]

In a clinical trial with 43 smokers, nicotine polyestex gum led to a significantly higher smoking cessation rate of 50% compared to only 9% for the placebo group after 3 months, indicating its effectiveness.

The gum was found to be safe, with adverse events occurring at similar rates to the placebo, and while both groups reported improved quality of life, there was no significant difference between them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nicotine polyestex gum on smoking cessation and quality of life. Rungruanghiranya, S., Ekpanyaskul, C., Hattapornsawan, Y., et al.[2017]

Nicotine gum, which binds nicotine to a polacrilex, is an effective method for treating tobacco dependence by transferring nicotine dependence from cigarettes to a safer form, reducing the risk of relapse.

The effectiveness of nicotine gum can be influenced by factors such as the dose, dosing schedule, and how vigorously it is chewed, highlighting the importance of proper administration for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic effects of nicotine polacrilex. Nemeth-Coslett, R.[2019]

Dental professionals can play a crucial role in helping patients quit smoking, as they frequently encounter smokers in their practice.

Effective smoking cessation programs in dental offices should include identifying smokers, assessing their motivation and nicotine dependence, prescribing nicotine replacement therapy when appropriate, providing personalized counseling, and ensuring follow-up support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing smoking cessation programs in dental offices. Cohen, SJ., Kelly, SA., Eason, AA.[2019]

In a 5-week study involving 156 patients with coronary artery disease, transdermal nicotine was found to be well tolerated, with no significant adverse cardiovascular effects reported, such as increased angina or arrhythmias.

Patients using transdermal nicotine achieved a smoking cessation rate of 36%, compared to 22% in the placebo group, indicating that transdermal nicotine is an effective aid for smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy for patients with coronary artery disease. Working Group for the Study of Transdermal Nicotine in Patients with Coronary artery disease. [2023]

Cigarette smoking is the leading cause of preventable death in the U.S., with over 3,000 children starting to smoke daily, highlighting the urgent need for effective smoking cessation strategies.

Pharmacological interventions, such as Zyban and various nicotine replacement therapies (like patches and gum), can help alleviate withdrawal symptoms and support individuals in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using nicotine replacement therapy in treating nicotine addiction in adolescents. Maharaj, K., Ternullo, S.[2018]

In a study involving 421 nicotine-dependent smokers, those who continued using the nicotine patch for an additional 4 weeks after the initial 6 weeks reported significantly lower cravings and withdrawal symptoms compared to those using a placebo patch.

The findings suggest that extending nicotine patch treatment to 10 weeks can be beneficial for some smokers in managing cravings and improving mood during the early stages of abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the nicotine patch for relief of craving and withdrawal 7-10 weeks after cessation. Shiffman, S., Khayrallah, M., Nowak, R.[2019]

A new nicotine nasal spray (NNS) significantly improved smoking cessation success rates compared to a placebo in a study of 255 smokers, with continuous abstinence rates showing marked differences at various intervals (e.g., 63% vs. 40% on day 5).

The NNS was found to be safe and well-tolerated, providing a faster-acting alternative to traditional nicotine replacement therapies, with side effects being common but manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. Schneider, NG., Olmstead, R., Mody, FV., et al.[2019]

In a study of 186 participants, only 1.6% showed delayed contact sensitization to the nicotine transdermal system, indicating a low risk of allergic reactions.

The transdermal nicotine system was well tolerated, with less than 3% of applications causing nonallergic skin irritation, and all reactions resolved without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) Jordan, WP.[2015]

In a clinical trial with 1818 smokers, the nicotine polacrilex lozenge demonstrated significant efficacy for smoking cessation, achieving 28-day abstinence rates of 46.0% for the 2-mg dose and 48.7% for the 4-mg dose compared to much lower rates in placebo groups.

The lozenge not only helped smokers quit but also reduced cravings and withdrawal symptoms, with most side effects being moderate and similar to those experienced with nicotine gum, indicating it is a safe option for both low- and high-dependence smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine lozenge for smoking cessation. Shiffman, S., Dresler, CM., Hajek, P., et al.[2022]

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