Financial Counseling + Nicotine Replacement for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen by Erin Rogers, DrPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Heart attack, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.

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 mainly focuses on smoking cessation and financial counseling.

What data supports the effectiveness of the treatment Financial Counseling + Nicotine Replacement for Smoking Cessation?

Research shows that nicotine replacement therapy (NRT), including gum, patches, and lozenges, increases the chances of quitting smoking. A meta-analysis found that using NRT significantly improves the likelihood of quitting compared to not using it. ^{1 2 3 4 5}

Is nicotine replacement therapy safe for humans?

Nicotine replacement therapy (NRT), including patches and lozenges, is generally considered safe for humans. Studies have shown that while some users may experience mild side effects, there are no serious adverse events reported when used as directed. ^{3 6 7 8 9}

How is the treatment of financial counseling combined with nicotine replacement therapy unique for smoking cessation?

This treatment is unique because it combines financial counseling with nicotine replacement therapy (NRT) using gum, lozenges, and patches, which may enhance adherence and success rates by addressing both the financial and physical aspects of quitting smoking. ^{2 10 11 12 13}

Research Team

Erin Rogers, DrPH

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for smokers over 18 living in New York City, earning below twice the federal poverty level, and smoking at least 5 cigarettes a day. They must speak English or Spanish, be able to consent, manage their own funds, and want help quitting smoking and managing finances. Pregnant women, recent heart attack patients, those with certain heart conditions or nicotine patch allergies can't join.

Inclusion Criteria

New York City resident

Able to provide informed consent

I am 18 years old or older.

Exclusion Criteria

People who know a current past study participant (to avoid intervention contamination)

I cannot use nicotine patches due to health reasons or pregnancy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 counseling sessions over approximately 8 weeks and 8 weeks of nicotine replacement therapy

8 weeks

5 visits (in-person or virtual)

Follow-up

Participants are monitored for smoking cessation outcomes and mechanisms at 6 and 12 months

12 months

2 visits (in-person or virtual) at 6 and 12 months

Treatment Details

Interventions

• Financial counseling (Behavioural Intervention)
• Nicotine Replacement Therapy Agent - Gum (Nicotine Replacement Therapy Agent)
• Nicotine Replacement Therapy Agent - Lozenges (Nicotine Replacement Therapy Agent)
• Nicotine Replacement Therapy Agent - Patches (Nicotine Replacement Therapy Agent)

Trial Overview The study compares two approaches: (1) Standard Smoking Cessation Counseling alone (Control group), versus (2) Integrated Financial-Smoking Cessation Counseling which combines financial advice with quit-smoking support (Intervention group). It's a randomized controlled trial involving 900 participants divided equally between both groups.

Participant Groups

Group I: Integrated Financial-Smoking Cessation Coaching Experimental Treatment 4 Interventions

The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).

Group II: Standard Smoking Cessation Coaching Active Control 3 Interventions

Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).

Nicotine Replacement Therapy Agent - Gum is already approved in Canada for the following indications:

Approved in Canada as Nicotine Gum for:

• Smoking cessation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

In a study of 72 smokers over 12 weeks, nicotine patches were found to be more effective than nicotine gum for smoking cessation, with higher quit rates and better adherence among participants.

Salivary cotinine levels, which were measured to assess nicotine intake, showed a significant reduction in the patch group compared to the gum group, indicating that patches may provide a more reliable method for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of the efficacy of nicotine chewing gum and nicotine patches as nicotine replacement therapy using salivary cotinine levels as a biochemical validation measure. Sivasankari, T., Sankaran, A., Murugappan, S., et al.[2023]

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]

Mucoadhesive nicotine tablets can effectively deliver nicotine in a controlled manner, helping individuals gradually reduce their dependence on smoking.

The best formulation for these tablets was found to be a mixture of Hydroxypropyl Methylcellulose (HPMC 50cps) and Carbopol 934, which provided optimal adhesiveness and a stable release rate of nicotine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulation of nicotine mucoadhesive tablet for smoking cessation and evaluation of its pharmaceuticals properties. Bahri-Najafi, R., Rezaei, Z., Peykanpour, M., et al.[2021]

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 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]

In a pharmacy-based study of 633 smokers using the OTC nicotine patch Nicotinell, 28% successfully quit smoking after 24 weeks, indicating the patch's effectiveness in promoting smoking cessation.

The study found no serious adverse events related to the nicotine patch, suggesting it is safe for use; however, only 62.9% of participants followed the recommended usage guidelines, highlighting a need for better compliance education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation. Hasford, J., Fagerstrom, KO., Haustein, KO.[2018]

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]

Nicotine is identified as the primary cause of tobacco dependence, acting through positive reinforcement by stimulating nicotinic receptors and causing withdrawal symptoms when not used, which complicates cessation efforts.

Nicotine replacement therapy effectively alleviates withdrawal symptoms, allowing smokers to focus on behavioral changes, and when combined with nonpharmacologic interventions, it significantly increases the chances of successful smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy. Thompson, GH., Hunter, DA.[2017]

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 introduction of nicotine replacement therapy (NRT) in Minnesota's QUITPLAN helpline led to a significant increase in call volume, from 2734 calls pre-NRT to 12,536 calls post-NRT, indicating heightened interest in smoking cessation support.

Enrollment in multisession counseling rose dramatically from 17.4% to 75.3% after NRT was made available, suggesting that providing NRT can effectively enhance participation in comprehensive smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to nicotine replacement therapy as part of a statewide tobacco telephone helpline. An, LC., Schillo, BA., Kavanaugh, A., et al.[2018]

In a study of 84,667 patients in a smoking cessation program, it was found that the prescribed doses of nicotine replacement therapy (NRT) did not increase adequately with the number of cigarettes smoked per day, leading to potential under-treatment.

Patients who received initial NRT doses below 2 mg per cigarette per day had poorer cessation outcomes, suggesting that higher doses may be necessary for heavy smokers to improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. Veldhuizen, S., Behal, A., Zawertailo, L., et al.[2023]

In a study of 357 smokers, those who achieved abstinence after two months of supportive smoking cessation counseling (SSCC) or nicotine replacement therapy (NRT) were significantly more likely to remain abstinent after one year, with an odds ratio of 19.4.

The initial two-month abstinence rates were 34% for the SSCC group and 52.1% for the NRT group, indicating that early success in quitting can predict long-term outcomes and may help tailor future treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two-month results are predictors of outcome in a smoking cessation program]. Barrueco, M., Torrecilla, M., Angel Maderuelo, J., et al.[2019]

References

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

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

2. India pubmed.ncbi.nlm.nih.gov

Comparative evaluation of the efficacy of nicotine chewing gum and nicotine patches as nicotine replacement therapy using salivary cotinine levels as a biochemical validation measure. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. India pubmed.ncbi.nlm.nih.gov

Formulation of nicotine mucoadhesive tablet for smoking cessation and evaluation of its pharmaceuticals properties. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

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

A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation. [2018]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Nicotine replacement therapy. [2017]

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

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

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

Access to nicotine replacement therapy as part of a statewide tobacco telephone helpline. [2018]

12. Ireland pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. [2023]

13. Spain pubmed.ncbi.nlm.nih.gov

[Two-month results are predictors of outcome in a smoking cessation program]. [2019]