Smoking Cessation Program for Quitting Smoking
Recruiting in Palo Alto (17 mi)
Overseen byTaghrid 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?
Is the smoking cessation treatment generally safe for humans?
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.25101112
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
See 11 more
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 OverviewThe 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
3Treatment groups
Experimental Treatment
Group I: Tobacco Quit-line (TQL) GroupExperimental Treatment1 Intervention
Participants will be referred to the TQL and will be followed up for up to 12 months.
Group II: Intensive Behavioral Counseling GroupExperimental Treatment2 Interventions
Participants will receive four behavioral counseling sessions and be followed up for 12 months.
Group III: Brief Behavioral Counseling GroupExperimental Treatment3 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Don Soffer Clinical Research CenterMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
Florida Department of HealthCollaborator
References
Effect of nicotine polyestex gum on smoking cessation and quality of life. [2017]To determine the effectiveness and safety of the novel nicotine polyestex gum for smoking cessation, along with its impact on the quality of life (QOL).
Stop-smoking program using nicotine reduction therapy and behavior modification for heavy smokers. [2019]One hundred eighteen volunteers were studied in a hospital-based smoking cessation program in which nicotine polacrilex (Nicorette) was used as an adjunct to behavioral modification (group support). The "success" rate of 40% to 47% at 1 year was chemically verified. The regimen for using the nicotine polacrilex was "within labeling" but decidedly different from the regimen used in most smoking cessation programs involving this product.
Physiologic effects of nicotine polacrilex. [2019]Nicotine is the pharmacologically active agent in tobacco responsible for the maintenance of cigarette smoking behavior. Paradoxically, nicotine also offers the most promise in the successful treatment of cigarette smoking when it is delivered to the central nervous system in a safer and more manageable form. By transferring the physiologic dependence from nicotine contained in tobacco to nicotine bound in a polacrilex, the behavioral aspects associated with cigarette smoking can be removed with a minimal amount of discomfort or risk of relapse. Nicotine bound to a polacrilex and administered as a chewing gum is currently the replacement of choice since many of the systemic effects of nicotine delivered via this route are similar to the effects of nicotine delivered in cigarette smoke without the accompanying exposure to carbon monoxide and tar. Factors such as administered dose, schedule of dosing, and rate and vigor of chew, however, can significantly alter the desired effects. This paper provides a summary of the physiologic changes which may affect the effectiveness of nicotine gum as a pharmacologic adjunct in the treatment of tobacco dependence.
Efficacy of a nicotine lozenge for smoking cessation. [2022]Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation.
Nicotine-replacement products in smoking cessation: a review. [2018]Smoking cessation programmes have gained greater prominence in Singapore in the face of growing desire among smokers to stop smoking. There exists a whole plethora of different methods which are employed in smoking cessation; this reflects the fact that smoking is a compulsive habit which is difficult to stop. Most attempts at smoking cessation fail, and the failure is largely attributable to the addictive properties of nicotine, which causes a withdrawal syndrome when the body is deprived of it. A host of medications have been used in the past in an attempt to alleviate this withdrawal syndrome. Of these products, perhaps the most promising are the nicotine-replacement products. These products consist of nicotine which is delivered through contrasting delivery systems viz polacrilex gum, transdermal patches, nasal sprays and inhalers. A review of recent clinical trials assessing the efficacy of the nicotine gum and the transdermal nicotine patch was conducted. Of the two products, the transdermal nicotine patch seems to have superior pharmacokinetics and fewer side-effects, and may well be the product of choice.
Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) [2015]Transdermal nicotine therapy has shown promise as a smoking cessation aid, but questions about its contact sensitization potential and long-term topical safety have been raised. The purpose of this study was to determine the contact sensitization potential of one nicotine transdermal system (Nicoderm, Marion Merrell Dow Inc, Kansas City, Mo, and ALZA Corporation, Palo Alto, Calif) in a population who were allowed to continue smoking.
Efficacy of the nicotine patch for relief of craving and withdrawal 7-10 weeks after cessation. [2019]The objective of this study was to test the efficacy of the nicotine patch for relief of craving and withdrawal beyond 6 weeks (during weeks 7-10), among heavy, dependent smokers, using a multicenter, randomized, double-blind, placebo-controlled trial. The subjects were 421 nicotine-dependent smokers who had quit smoking with the NicoDerm CQ nicotine patch, recruited from among enrollees in the NicoDerm CQ Committed Quitters behavioral program. Following 6 weeks of 21-mg active patch use, participants who had not relapsed were randomized to receive either active or placebo patches for an additional 4 weeks with tapering (14-mg patch in weeks 7-8 and 7-mg patch in weeks 9-10). Craving and withdrawal symptoms were assessed daily by phone interview during weeks 7-10 following cessation. The active patch group reported significantly lower craving and withdrawal, and higher positive mood scores in weeks 7-8 (p
Nicotine replacement therapy for patients with coronary artery disease. Working Group for the Study of Transdermal Nicotine in Patients with Coronary artery disease. [2023]Because nicotine can cause adverse cardiovascular effects, we assessed the safety of transdermal nicotine for smoking cessation in patients with coronary artery disease.
Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. [2019]This randomized, crossover study compared the nicotine and cotinine pharmacokinetic parameters and plasma concentration profiles of two different nicotine transdermal products: Nicoderm (Alza, Palo Alto, CA; and Marion Merrell Dow, Kansas City, MO) and Habitrol (Basel Pharmaceuticals, Summit, NJ). The two treatments were randomly assigned to each of 24 male smokers and worn for 24 hours each day for 5 days, with a 6-day washout between treatments. Plasma nicotine and cotinine concentrations were measured on day 1 and day 5 of each treatment. Mean delivered dose differed significantly between products, and the two products were not bioequivalent. The Nicoderm system provided higher mean plasma nicotine concentrations, particularly during the first 8 hours after system application. The mean steady state Cmax, AUC, and degree of fluctuation (DF) values were significantly greater for the Nicoderm system than for Habitrol. The mean nicotine tmax value for the Nicoderm system was significantly shorter (P
Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. [2019]Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS was tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at weeks 2, 3, 6 and at 3 months, 6 months and 1 year. Continuous abstinence analyses (CO
Using nicotine replacement therapy in treating nicotine addiction in adolescents. [2018]Cigarette smoking is the greatest cause of preventable death and disability in the United States. More than 3,000 children in the United States begin smoking each day. Smokers experience withdrawal symptoms that can be ameliorated by pharmacological interventions. These interventions include Zyban (Bupropion HCl), Nicorette gum, Habitrol patch, Nicoderm patch, Nicotrol inhaler, and Nicotrol NS spray, along with their generic counterparts. This article reviews each of these agents, the time course of nicotine withdrawal symptoms, and the Fagerstrom Tolerance Questionnaire and presents a framework for assisting the nicotine-addicted student in smoking cessation.
Establishing smoking cessation programs in dental offices. [2019]Cigarette smoking is the leading cause of preventable death and disease in the United States. Because dental personnel treat millions of patients who are cigarette smokers, they have a unique opportunity to help persons quit the smoking habit. Effectively designed, office-based programs should involve all or most dental team members and contain the following components: a procedure that identifies smokers and records changes in their smoking status, a personal evaluation of each smoker's motivation to quit, an assessment of the degree of nicotine dependence experienced by potential quitters, the prescription of nicotine polacrilex therapy for appropriate candidates, personalized counseling commensurate with each patient's level of quitting readiness and, an effective system that ensures consistent patient follow-up and support.