Smoking Cessation Aids for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Overseen by Melissa A Little, PhD,MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Virginia

Must be taking: Nicotine replacement

Disqualifiers: Heart attack, Stroke, Angina, others

No Placebo Group

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}

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 18 years old or older.

Exclusion Criteria

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

Trial 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 (Drug)
• Nicotine Replacement Therapy Patch (Drug)
• QuitAid (Behavioral Intervention)
• SmokefreeTXT (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia Charlottesville, VA

Who Is Running the Clinical Trial?

University of Virginia Lead Sponsor

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] Nicotine replacement therapies are efficacious for treating nicotine dependence. However, limited data exist on benefits of different NRTs and predictors of treatment outcome. This study compared the effectiveness of transdermal nicotine vs. nicotine lozenge for smoking cessation and identified predictors of treatment response.

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

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.

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

Telephone support as an adjunct to transdermal nicotine in smoking cessation. [2019] Transdermal nicotine patches have shown considerable promise in improving smoking cessation outcomes. The present study assessed telephone support as an adjunct to a managed care-based, single-session group orientation smoking cessation program with nicotine patch therapy.

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

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. [2019] Pharmacological interventions for smoking cessation are typically evaluated using volunteer samples (efficacy trials) but should also be evaluated in population-based trials (effectiveness trials). Nicotine replacement therapy (NRT) alone and in combination with behavioral interventions was evaluated on a population of smokers from a New England Veterans Affairs Medical Center. Telephone interviews were completed with 3,239 smokers, and 2,054 agreed to participate (64%). Participants were randomly assigned to one of four conditions: stage-matched manuals (MAN); NRT plus manuals (NRT + MAN); expert system plus NRT and manuals (EXP + NRT + MAN); and automated counseling plus NRT, manuals, and expert system (TEL + EXP + NRT + MAN). Assessments were completed at baseline, 10, 20, and 30 months. The point prevalence cessation rates at final follow-up (30 months) were MAN, 20.3%; NRT + MAN, 19.3%; EXP + NRT + MAN, 17.6%; and TEL + EXP + NRT + MAN, 19.9%. Stage-matched manuals provided cessation rates comparable with previous studies. The addition of NRT, expert system interventions, and automated telephone counseling failed to produce a further increase in intervention effectiveness.

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] Novel approaches to nicotine replacement therapy (NRT) are needed to improve the modest long-term quit rate of 10%. Snus (Swedish tobacco) and Zonnic (oral nicotine sachet) rapidly deliver nicotine via buccal absorption and have potential as NRTs. As a prelude to formal evaluation of either product as a smoking cessation therapy, it is necessary to determine their acceptability and the willingness of smokers to use them in populations with no history of access to oral tobacco products.

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] INTRODUCTION. Nicotine replacement therapies (NRT) are effective for smoking cessation. After having received over-the-counter (OTC) status in Germany, concerns grew about effectiveness, increased risks, especially of adverse cardiovascular reactions, and inappropriate use of NRT. Thus, a pharmacy-based cohort study was launched. OBJECTIVES. To assess effectiveness, safety and appropriateness of use of an OTC nicotine patch (Nicotinell, Novartis Ltd.). Every customer who bought an OTC Nicotinell patch was eligible. All data were collected by self-administered questionnaires at weeks 2, 4, 8, 12 and 24 after inclusion. Six hundred and thirty-three customers were admitted, median duration of smoking was 19 years. Of the participants, 6% smoked up to 10 cigarettes per day, 43.6% between 11 and 20, 34.3% between 21 and 30, and 16.1% more than 30 cigarettes. Twenty-four weeks later, 351 participants replied: 28% (177 of 633) had quit smoking completely. Considering replies only the proportion of complete responders raised to 50.4%. There were no serious adverse events reported; 62.9% complied with the directions for use and did not use the patch for more than 3 months. About 45% smoked simultaneously with NRT. Pharmacy-based cohort studies are feasible. This study indicates that the nicotine patch is effective and safe in an OTC setting. There is still room to improve compliance with the directions for use.

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

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.

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

Using new information technology to treat tobacco dependence. [2017] Smoking cessation programs that can be disseminated at a large scale and at a low cost are needed to decrease smoking-related mortality and morbidity. Research showed that several computer-based smoking cessation programs are effective, in particular when they are combined with pharmacotherapy. When available on the Internet, these programs can reach thousands of smokers at a low cost per participant. Some of these programs are designed to complement smoking cessation counseling given by physicians to their patients who smoke. They can be a useful adjunct to medical advice and should be prescribed in association with pharmacotherapy.

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

Smoking cessation techniques. [2017] A key responsibility for all health care professionals is to advise patients to quit smoking, which means being knowledgeable about smoking cessation programs and methods. This article considers both assisted and self-help methods of smoking cessation and their application to female smokers. The most effective assisted programs employ multiple interventions, primarily behavioral, but also pharmacologic, in the form of nicotine replacement. Smoking cessation products have not generally proven effective with the exception of nicotine polacrilex gum and the transdermal nicotine patch. Use of nicotine replacement, especially the patch, in smokers who are pregnant or nursing is controversial. In addition to pregnant women, those with young children and those of color and low socioeconomic status represent important high-risk target populations. Very little work has been done with female adolescents.

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

Reduction of abstinence-induced withdrawal and craving using high-dose nicotine replacement therapy. [2019] Decreasing withdrawal and craving during smoking cessation is a major aim of cessation medications. Prior studies have shown that Nicotine Replacement Therapy (NRT) decreases withdrawal symptom severity but have relied on retrospective reports and lacked robust measures of baseline symptoms or symptoms during unmedicated abstinence.