Smoking Cessation Program for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Overseen by Taghrid Asfar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Miami

Disqualifiers: Current cigarette smoker

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

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

Trial 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 (Behavioural Intervention)
• Intensive Behavioral Counseling (Behavioural Intervention)
• Nicoderm C-Q Gum (Nicotine Replacement Therapy)
• Tobacco Quit-line (Behavioural Intervention)

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 Canada for the following indications:

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+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Findings from Research

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 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]

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]