Smoking Cessation Program for Quitting Smoking

Overseen By Alejandra Casas, BS

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

Trial Summary

What is the purpose of this trial?

The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.

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 data supports the effectiveness of the treatment for smoking cessation?

Research shows that nicotine replacement products like nicotine gum and lozenges can help people quit smoking by reducing withdrawal symptoms. A study found that using nicotine polacrilex gum with behavioral support had a success rate of 40% to 47% after one year. ^{1 2 3 4 5}

Is the smoking cessation treatment generally safe for humans?

Research indicates that nicotine replacement therapies like the nicotine patch and lozenge are generally safe for humans, even for those with coronary artery disease, though they may have some potential for skin irritation (contact sensitization) when used as a patch. ^{4 6 7 8 9}

How is Nicoderm C-Q Gum different from other smoking cessation drugs?

Nicoderm C-Q Gum is a nicotine replacement therapy that provides nicotine through chewing gum, which can be more flexible and immediate in addressing cravings compared to slower-acting options like patches. It is often used alongside behavioral support to improve success rates in quitting smoking. ^{2 5 10 11 12}

Research Team

Taghrid Asfar, MD

Principal Investigator

[e-mail]

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: 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.

Group II: Intensive Behavioral Counseling Group Experimental Treatment 2 Interventions

Participants will receive four behavioral counseling sessions and be followed up for 12 months.

Group III: Brief Behavioral Counseling Group Experimental Treatment 3 Interventions

Participants will receive one brief behavioral counseling session and be followed up for 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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

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]

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]

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]

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]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Effect of nicotine polyestex gum on smoking cessation and quality of life. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Stop-smoking program using nicotine reduction therapy and behavior modification for heavy smokers. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Physiologic effects of nicotine polacrilex. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine lozenge for smoking cessation. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Nicotine-replacement products in smoking cessation: a review. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of the nicotine patch for relief of craving and withdrawal 7-10 weeks after cessation. [2019]

8. United States 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]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Using nicotine replacement therapy in treating nicotine addiction in adolescents. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Establishing smoking cessation programs in dental offices. [2019]