Smoking Cessation Aids for Quitting Smoking

Overseen By Abbey G Wester, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Nicotine replacement

Disqualifiers: Heart attack, Stroke, Angina, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be willing and able to use nicotine replacement therapy (NRT) like patches or lozenges.

What data supports the effectiveness of the drug Nicotine lozenge for quitting smoking?

Research shows that nicotine replacement therapies, like nicotine lozenges and patches, can help people quit smoking by reducing withdrawal symptoms. A study found that transdermal nicotine patches improve smoking cessation outcomes, and another study confirmed that nicotine lozenges are effective in treating nicotine dependence. ^{1 2 3 4 5}

Is nicotine replacement therapy safe for humans?

Research indicates that nicotine replacement therapies, like nicotine patches and lozenges, are generally safe for humans. A study on over-the-counter nicotine patches found no serious adverse events, suggesting they are safe when used as directed. ^{1 2 3 6 7}

How is the smoking cessation treatment with nicotine lozenge, patch, QuitAid, and SmokefreeTXT different from other treatments?

This treatment is unique because it combines multiple approaches: nicotine lozenges and patches for physical cravings, QuitAid for medication management, and SmokefreeTXT for behavioral support through text messages, offering a comprehensive strategy to help people quit smoking. ^{2 3 8 9 10}

Research Team

Melissa A Little, PhD,MPH

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for adult patients at participating health centers who smoke more than 5 cigarettes daily, own a cell phone, and are willing to use nicotine patches or lozenges. They must not be pregnant nor plan pregnancy within six months and have no recent severe heart issues.

Inclusion Criteria

Patient at participating Federally Qualified Health Center

Reports smoking ≥5 cigarettes per day for the past 6 months

I am willing to use nicotine replacement therapy like patches or lozenges.

Exclusion Criteria

I cannot use nicotine replacement therapy due to recent heart issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Quit Sessions

Participants not ready to quit receive 2 pre-quit sessions focused on rate reduction

2 weeks

2 visits (in-person)

Treatment

Participants receive QuitAid, a texting intervention, and up to 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge

8 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for smoking cessation effectiveness and adherence to the intervention

12 weeks

4 visits (in-person) at 2, 4, 8, and 12 weeks

Treatment Details

Interventions

• Nicotine lozenge
• Nicotine Replacement Therapy Patch
• QuitAid
• SmokefreeTXT

Trial Overview The study tests the feasibility of a pharmacist-led smoking cessation program using QuitAid tools, Nicotine Replacement Therapy Patch, lozenges, and SmokefreeTXT in low-income community health centers.

Participant Groups

Group I: QuitAid + SmokefreeTXT + NRT (Patch + Lozenge) Experimental Treatment 4 Interventions

Participants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.

Group II: SmokefreeTXT + NRT (Patch + Lozenge) Active Control 3 Interventions

Participants will receive a texting intervention to help quit smoking and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.

Nicotine lozenge is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Nicorette Lozenge for:

• Smoking cessation

Approved in Canada as Nicotrol Lozenge for:

• Smoking cessation

Approved in European Union as Nicorette Lozenge for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Findings from Research

In a study of 642 smokers, transdermal nicotine showed a trend towards higher quit rates compared to nicotine lozenges, with 24.3% quitting at the end of treatment versus 18.7% for lozenges.

Smokers who preferred transdermal nicotine and did not use nicotine to manage emotional distress had better success rates, suggesting that individual preferences and reasons for smoking can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. Schnoll, RA., Martinez, E., Tatum, KL., et al.[2022]

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]

The study involved 509 participants and assessed the effectiveness of telephone support alongside a single-session group orientation smoking cessation program with nicotine patches, but found no significant differences in abstinence rates between groups.

Overall, the smoking cessation program achieved a 22% abstinence rate at 6 months and 21% at 1 year, indicating that while the program was effective, additional telephone support did not enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone support as an adjunct to transdermal nicotine in smoking cessation. Lando, HA., Rolnick, S., Klevan, D., et al.[2019]

In a study involving 2,054 smokers from a Veterans Affairs Medical Center, various smoking cessation interventions were tested over 30 months, showing that stage-matched manuals alone achieved a cessation rate of 20.3%.

Adding nicotine replacement therapy (NRT) and other expert or automated counseling methods did not significantly improve cessation rates compared to the manuals alone, indicating that the effectiveness of these additional interventions may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. Velicer, WF., Friedman, RH., Fava, JL., et al.[2019]

In a study involving 63 smokers, both snus and Zonnic were preferred over nicotine gum, showing greater effectiveness in reducing smoking urges and causing fewer side effects.

Participants experienced significant reductions in smoking (33% for gum, 37% for snus, and 42% for Zonnic), indicating that snus and Zonnic could be promising alternatives for nicotine replacement therapy, warranting further research on their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. Caldwell, B., Burgess, C., Crane, J.[2022]

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 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]

Computer-based smoking cessation programs are effective and can be delivered on a large scale at a low cost, making them accessible to many smokers.

These programs work best when combined with pharmacotherapy and can serve as a helpful addition to counseling provided by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. Etter, JF.[2017]

Assisted smoking cessation programs that combine behavioral interventions with pharmacologic methods, particularly nicotine replacement therapies like gum and patches, are the most effective for helping female smokers quit.

There is controversy surrounding the use of nicotine replacement therapies in pregnant or nursing women, highlighting the need for targeted approaches for high-risk populations, including women with young children and those from low socioeconomic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation techniques. Lando, HA., Gritz, ER.[2017]

A study involving 324 smokers showed that high-dose nicotine patches (35 mg) significantly reduced withdrawal symptoms and cravings during smoking cessation, using real-time assessments with electronic diaries.

The active nicotine patches not only decreased withdrawal severity but also completely eliminated some symptoms related to deprivation, such as changes in mood and concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of abstinence-induced withdrawal and craving using high-dose nicotine replacement therapy. Shiffman, S., Ferguson, SG., Gwaltney, CJ., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Telephone support as an adjunct to transdermal nicotine in smoking cessation. [2019]

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

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. [2019]

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

Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. [2022]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. [2017]

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

Smoking cessation techniques. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

Reduction of abstinence-induced withdrawal and craving using high-dose nicotine replacement therapy. [2019]