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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help low-income smokers quit, focusing on those not actively seeking help. The study examines a combination of treatments, including nicotine patches, lozenges, and a text messaging program (SmokefreeTXT), delivered through Federally Qualified Health Centers. Participants will either receive a full package with additional pharmacist support or just the text messaging and nicotine replacements. Smokers who have been smoking at least 5 cigarettes a day for the past 6 months and are patients at these health centers might be suitable if they are ready to try nicotine patches or lozenges. As an unphased trial, this study provides a unique opportunity to explore innovative methods for quitting smoking.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this smoking cessation trial are generally safe and well-tolerated. QuitAid, a program run by pharmacists, has demonstrated promising results. Serious side effects were rare, occurring in less than 1.5% of participants, and less than 3% discontinued treatment because of them.

The SmokefreeTXT program, which sends supportive text messages, is considered very safe. Since it focuses on support through messages rather than medication, serious side effects are unlikely.

Nicotine replacement therapies (NRT) like lozenges and patches are also safe. Common side effects of the nicotine lozenge include dizziness, headaches, and mouth irritation, which are usually mild. The nicotine patch may cause skin irritation and sometimes headaches or nausea, but these effects are typically manageable.

Overall, these treatments have been widely used and are considered safe for helping people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking cessation because they combine multiple support methods that could enhance quitting success. Unlike standard treatments that typically focus on one method, these options combine the use of Nicotine Replacement Therapy (NRT) with innovative support tools. The first treatment arm includes QuitAid, which provides personalized medication management by a pharmacist, alongside SmokefreeTXT, a supportive texting intervention. This multi-faceted approach aims to provide comprehensive support, addressing both the physical and behavioral aspects of quitting smoking. The second treatment arm focuses on SmokefreeTXT paired with NRT, aiming to leverage digital support to reinforce nicotine replacement strategies. By integrating these methods, researchers hope to improve quit rates and offer a more robust support system for individuals looking to quit smoking.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research has shown that nicotine replacement therapies (NRT), such as patches and lozenges, are generally safe and assist people in quitting smoking. These treatments provide a small, controlled amount of nicotine to the body, reducing withdrawal symptoms when smoking ceases. In this trial, one group of participants will receive QuitAid, a pharmacist-run program, along with SmokefreeTXT and NRT. Early results suggest that QuitAid can enhance quitting success by managing medication and supporting adherence to treatment. Another group will receive SmokefreeTXT and NRT without QuitAid. SmokefreeTXT, a texting service, aids by sending motivational messages and tips. Together, these tools aim to help smokers quit more effectively, particularly in underserved communities. ^{6 7 8 9 10}

Who Is on the Research Team?

Melissa A Little, PhD,MPH

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. quitaid.org quitaid.org/info/

Study Information Smokers will participate in a smoking cessation program that includes the use of nicotine replacement therapy (NRT) in the form of the patch and/or lozenge.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05660525

Leveraging Community Pharmacists to Optimize Smoking ... Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form ...

3. withpower.com withpower.com/trial/phase-smoking-cessation-2-2023-f20ed

QuitAid for Quitting Smoking Research indicates that nicotine replacement therapies, like nicotine lozenges and patches, are generally safe for humans. A study on over-the-counter ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05660525/leveraging-community-pharmacists-to-optimize-smoking-cessation-services-for-rural-smokers-in-appalachia

Leveraging Community Pharmacists to Optimize Smoking ... Aim 1 of this project will evaluate the effectiveness of QuitAid and standard, evidence-based tobacco treatments on cessation within an MTM ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06161675/

Trial | NCT06161675 Participants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2917405/

Adverse events associated with nicotine replacement therapy ... Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains.

7. mayoclinic.org mayoclinic.org/drugs-supplements/nicotine-transdermal-route/description/drg-20068808

Nicotine (transdermal route) - Side effects & dosage Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and patches contain ...

8. medlineplus.gov medlineplus.gov/druginfo/meds/a601084.html

Nicotine Transdermal Patch: MedlinePlus Drug Information Nicotine Transdermal Patch: learn about side effects, dosage, special precautions, and more on MedlinePlus.

9. my.clevelandclinic.org my.clevelandclinic.org/health/drugs/19145-nicotine-patches

Nicotine Patch: How to Use & Side Effects A nicotine patch helps you quit smoking by reducing cravings for nicotine. Nicotine is an addictive substance in tobacco.

10. goodrx.com goodrx.com/health-topic/nicotine/nicotine-patch-side-effects?srsltid=AfmBOorkrl_sP-5et_WeqEDTk0whkq4PrQxW6ZV9k3J3Riwu2hSdObKY

8 Nicotine Patch Side Effects and How to Manage Them 8 Nicotine Patch Side Effects To Know About · 1. Skin irritation · 2. Headaches · 3. Nausea · 4. Trouble sleeping · 5. Vivid dreams · 6. High blood ...