Financial Incentives + NRT for Smoking Cessation

Overseen By Diann Gaalema, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Dementia, Active malignancy, Vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

50 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 4 11 12 13}

Eligibility 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.

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

Treatment Details

Interventions

• Financial Incentives
• Nicotine Replacement Therapy

Trial Overview 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.

Participant Groups

Group I: Intervention: Financial incentives and nicotine replacement therapy intervention Experimental Treatment 1 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 Care Active Control 1 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

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Findings from Research

A meta-analysis of 53 randomized controlled trials involving 17,703 subjects found that nicotine-replacement therapy (NRT) significantly increases the odds of smoking abstinence, with an overall odds ratio of 1.71 compared to control groups.

Different forms of NRT showed varying effectiveness, with inhaled nicotine being the most effective (odds ratio of 3.05), while the effectiveness was largely independent of the level of nicotine dependence and the intensity of additional support provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

Nicotinell lozenges, particularly the 1 mg formulation, have been shown to be bioequivalent to 2 mg nicotine gum, providing effective nicotine delivery for smoking cessation, with significant short-term efficacy demonstrated in over 900 smokers.

The lozenges have an excellent safety profile, with only mild and reversible adverse events reported, making them a safe option for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). Dautzenberg, B., Nides, M., Kienzler, JL., et al.[2023]

Nicotine replacement therapies (NRTs) significantly increase the chances of quitting smoking, with an overall odds ratio of 1.71 based on a review of 53 trials involving 17,703 patients.

Among different NRT forms, the transdermal patch and inhaled nicotine showed the highest effectiveness, with odds ratios of 2.07 and 3.05 respectively, indicating that these methods may be particularly beneficial for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

The recent FDA approval of a nicotine nasal spray enhances options for smoking cessation, allowing clinicians to tailor therapy based on individual patient needs.

The article provides guidance on the proper use, dosing, and management of side effects of the nicotine nasal spray, highlighting its role alongside other therapies like gum, patches, and bupropion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of nicotine nasal spray in smoking cessation. Montalto, NJ., Garrett, SD.[2015]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

The study found that three prototype 4-mg nicotine lozenges produced in India were bioequivalent to the globally marketed Nicorette® 4-mg lozenge, indicating they can effectively deliver similar levels of nicotine to the bloodstream.

All prototype lozenges were well tolerated and had safety profiles comparable to the reference product, suggesting they are a safe alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . Sukhija, M., Srivastava, R., Kaushik, A.[2018]

In a study of 248 smokers, those using nicotine nasal spray had a significantly higher success rate in quitting smoking for 12 months (27%) compared to those using a placebo (15%), indicating its efficacy as a smoking cessation aid.

While the nicotine nasal spray was effective, it was associated with more mild to moderate side effects compared to the placebo, suggesting that while it helps with quitting, users should be aware of potential discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study. Hjalmarson, A., Franzon, M., Westin, A., et al.[2015]

Nicotine replacement therapy (NRT) has evolved significantly over the past decade, with new delivery methods like mouth sprays, films, and electronic cigarettes showing promise in aiding smoking cessation and harm reduction.

The article reviews the efficacy and tolerability of these novel NRT products, highlighting their advantages and disadvantages compared to traditional NRT forms, which can help inform users about their options for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Shahab, L., Brose, LS., West, R.[2022]

In a review of 28 clinical trials involving 7,120 participants, only 10.5% experienced a significant increase in cotinine levels (>50% above baseline) while using nicotine replacement therapy (NRT), indicating that high nicotine exposure is relatively uncommon.

Adverse events related to nicotine overdose, such as nausea, vomiting, and palpitations, were reported infrequently (0.2% to 0.5% of subjects), supporting the overall safety of NRT for smoking cessation or reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Tonstad, S., Gustavsson, G., Kruse, E., et al.[2018]

A study involving 5200 Medicaid smokers showed that financial incentives significantly increased re-engagement in quitline services, with a dose-response effect observed; higher incentives led to higher re-engagement rates.

Mailed letters were more effective than phone calls for re-engagement, and the likelihood of re-engaging decreased as time since initial enrollment increased, highlighting the importance of timely interventions for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-engagement of Low-Income Smokers in Quitline Services: Effects of Incentives and Method of Contact. Cummins, SE., Kirby, CA., Wong, S., et al.[2023]

Financial incentives for healthcare professionals can enhance the recording of patients' smoking status and increase the provision of smoking cessation advice, as shown in a systematic review of 18 studies.

However, the evidence is mixed regarding whether these financial incentives actually lead to significant reductions in smoking rates or improved long-term abstinence, indicating that more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of providing financial incentives to healthcare professionals for smoking cessation activities: systematic review. Hamilton, FL., Greaves, F., Majeed, A., et al.[2018]

A study involving 430 adult smokers in the UK found that higher cash incentives for smoking cessation programs significantly increased participants' willingness to enroll, with a preference for consistent cash rewards and weekly sessions in healthcare settings.

While higher-income smokers preferred larger incentives, their willingness to enroll did not differ from lower-income smokers, suggesting that program design is crucial for maximizing participation across different income levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of Financial Incentive Programs for Smoking Cessation: A Discrete Choice Experiment. Breen, RJ., Palmer, MA., Frandsen, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. [2019]

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

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]

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

The effectiveness of nicotine replacement therapies in smoking cessation. [2019]

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

Utilization of nicotine nasal spray in smoking cessation. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]

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

Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study. [2015]

9. New Zealand pubmed.ncbi.nlm.nih.gov

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]

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

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Re-engagement of Low-Income Smokers in Quitline Services: Effects of Incentives and Method of Contact. [2023]

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

Effectiveness of providing financial incentives to healthcare professionals for smoking cessation activities: systematic review. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Design of Financial Incentive Programs for Smoking Cessation: A Discrete Choice Experiment. [2022]