Financial Incentives + NRT for Smoking Cessation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Vermont Medical Center
Disqualifiers: Dementia, Active malignancy, Vascular disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and does not mention changes to other medications.
What data supports the effectiveness of the treatment Financial Incentives + NRT for Smoking Cessation?
Research shows that nicotine replacement therapies (NRT), like gum, patches, and inhalers, can significantly increase the chances of quitting smoking. A meta-analysis found that using NRT increased the likelihood of quitting by 71% compared to not using it, and combining different forms of NRT may be even more effective.
12345Is nicotine replacement therapy (NRT) safe for humans?
Nicotine replacement therapy (NRT) is generally considered safe for humans, although some people may experience side effects or symptoms of nicotine toxicity, especially if they achieve high nicotine levels. Studies have shown that while NRT can help with smoking cessation, users should be aware of potential adverse effects and consult with healthcare providers if they have concerns.
678910How does the treatment of financial incentives plus NRT for smoking cessation differ from other treatments?
This treatment is unique because it combines financial incentives with nicotine replacement therapy (NRT) to encourage smoking cessation, particularly targeting low-income smokers. Financial incentives are used to motivate smokers to engage with quitline services, while NRT helps reduce withdrawal symptoms by providing a controlled dose of nicotine without the harmful effects of smoking.
14111213Eligibility Criteria
This trial is for adult smokers hospitalized due to a heart attack or heart surgery, living within 30 miles of UVMMC. Participants should be current cigarette users who have smoked more than 5 cigarettes per day in the past 3 months. Those with severe dementia, active cancer (except certain skin/prostate cancers), major exercise-limiting diseases, non-English speakers, or regular users of non-combusted tobacco are not eligible.Inclusion Criteria
I am over 18 and live within 30 miles of UVMMC.
I was hospitalized for a heart attack or heart surgery.
I currently smoke more than 5 cigarettes a day.
Exclusion Criteria
I have severe dementia or Alzheimer's disease.
I have cancer, but it's not low-grade prostate cancer or non-melanoma skin cancer.
I have a condition that limits my ability to exercise.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive financial incentives and nicotine replacement therapy to promote smoking cessation, starting in-hospital and continuing remotely after discharge
3 months
Remote monitoring and support
Follow-up
Participants are monitored for smoking status, anxiety, quality of life, depression, and physical function
12 months
Participant Groups
The study is testing if financial rewards and nicotine replacement therapy can help cardiac patients quit smoking after being hospitalized for a serious heart event. The goal is to see if these methods increase adherence to quitting smoking compared to usual care without incentives.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: Financial incentives and nicotine replacement therapy interventionExperimental Treatment1 Intervention
an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence
Group II: Control: Usual CareActive Control1 Intervention
will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Vermont Medical CenterBurlington, VT
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Who Is Running the Clinical Trial?
University of Vermont Medical CenterLead Sponsor
References
Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. [2019]Nicotine-replacement therapy (NRT) by gum, transdermal patch, intranasal spray, or inhalation is expensive but how effective is it? We have done a meta-analysis of controlled trials to see how effects on abstinence rates are influenced by the clinical setting, the level of nicotine dependency, the dosage of NRT, and the intensity of additional advice and support offered. Published or unpublished randomised controlled trials of NRT that have assessed abstinence at least 6 months after the start of NRT were identified and 53 trials (42 gum, 9 patch, 1 intranasal spray, 1 inhaler), with data from 17,703 subjects, were included in the analyses. Use of NRT increased the odds ratio (OR) of abstinence to 1.71 (95% confidence interval 1.56-1.87) compared with those allocated to the control interventions. The ORs for the different forms of NRT were 1.61 for gum, 2.07 for transdermal patch, 2.92 for nasal spray, and 3.05 for inhaled nicotine. These odds were non-significantly higher in subjects with higher levels of nicotine dependence but they were largely independent of the intensity of additional support provided or the setting in which NRT was offered. We conclude that the currently available forms of NRT are effective therapies to aid smoking cessation.
Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]Nicotine replacement therapy is an effective treatment for nicotine-dependent smokers. However, cessation rates are modest, and preliminary studies suggest that combination therapy may be superior. We compared the efficacy of the nicotine inhaler plus nicotine patch vs nicotine inhaler plus placebo patch for smoking cessation.
Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]The use of nicotine replacement therapy (NRT) can almost double the chances of success for smokers to quit. Nevertheless, there is still a considerable number of cessation attempts that are made without any treatment. This novel oral formulation, (lozenge containing nicotine bitartrate dihydrate) has been developed to enlarge the offer for efficient smoking cessation drug therapies, assuming that increasing treatment options will bring more smokers to find the support they personally need to stop smoking.
The effectiveness of nicotine replacement therapies in smoking cessation. [2019]To determine the effectiveness of nicotine replacement therapies (NRTs) (including gum, transdermal patch, intranasal spray, and inhaled preparations) in facilitating smoking cessation, and to determine whether the effect was influenced by the clinical setting in which the smoker was recruited and treated, the level of nicotine dependency, the dosage of NRT used, or the intensity of additional advice and support offered to the smoker.
Utilization of nicotine nasal spray in smoking cessation. [2015]It is widely accepted that nicotine replacement therapy can help patients to quit smoking. Recent approval by the US Food and Drug Administration of a nicotine nasal spray gives clinicians greater flexibility in choosing the best replacement therapy for a particular patient. Four types of smoking cessation therapy are currently available (gum, patch, nasal spray, and bupropion). These differ with respect to their onset and duration of action, adverse effects, and cost. This article focuses on which patients may benefit most from the use of nicotine nasal spray. Instructions for proper administration and dosing of the nicotine nasal spray are discussed as well as how to taper it appropriately, and how to avoid--and manage--adverse effects. Additionally, the cost of the nicotine nasal spray is reviewed and compared with over-the-counter products and bupropion. Resources for behavioral support are provided as well.
Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]Nicotine replacement therapy (NRT) increases quit rates and is increasingly distributed through quitlines, but no systematic data are available on adverse effects and safety among quitline NRT users.
Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]Nicotine replacement therapy (NRT) increases the probability of smoking cessation. This study was conducted to determine if three prototype 4-mg nicotine lozenges produced locally in India were bioequivalent to a globally marketed reference product, Nicorette® 4-mg nicotine lozenge.
Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study. [2015]Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the nicotine gum or nicotine patch owing to side effects. In addition, the absorption of nicotine from these formulas is slow compared with smoking. A nicotine nasal spray delivers nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the nicotine nasal spray for smoking cessation.
Novel delivery systems for nicotine replacement therapy as an aid to smoking cessation and for harm reduction: rationale, and evidence for advantages over existing systems. [2022]Nicotine replacement therapy (NRT) has been used in the treatment of tobacco dependence for over three decades. Whilst the choice of NRT was limited early on, in the last ten years there has been substantial increase in the number of nicotine delivery devices that have become available. This article briefly summarises existing forms of NRT, evidence of their efficacy and use, and reviews the rationale for the development of novel products delivering nicotine via buccal, transdermal or pulmonary routes (including nicotine mouth spray, nicotine films, advanced nicotine inhalers and electronic cigarettes). It presents available evidence on the efficacy, tolerability and abuse potential of these products, with a focus on their advantages as well as disadvantages compared with established forms of NRT for use as an aid to both smoking cessation as well as harm reduction.
Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. [2018]Nicotine replacement therapy (NRT) aids smoking reduction and cessation. Although NRT is effective and safe, some smokers may achieve high nicotine levels. The purpose of this study was to determine the incidence and severity of nicotine-related adverse events in subjects with levels of cotinine, a metabolite of nicotine, that increased by >50% compared with baseline smoking in controlled clinical trials of NRT.
Re-engagement of Low-Income Smokers in Quitline Services: Effects of Incentives and Method of Contact. [2023]Financial incentives have been shown to improve recruitment of low-income smokers into tobacco quitline services and to improve cessation outcomes. The present study evaluated their use to re-engage low-income smokers who had already used a quitline.
Effectiveness of providing financial incentives to healthcare professionals for smoking cessation activities: systematic review. [2018]Financial incentives are seen as one approach to encourage more systematic use of smoking cessation interventions by healthcare professionals. A systematic review was conducted to examine the evidence for this.
Design of Financial Incentive Programs for Smoking Cessation: A Discrete Choice Experiment. [2022]Financial incentive programs promote smoking cessation. However, the incentive amount which should be provided-and how this may interact with other program characteristics-is unknown. The objective of this study was to evaluate the influence of the design of incentive programs for smoking cessation on current smokers' perceptions of programs and willingness to enroll.