QuitAid for Quitting Smoking

Overseen By Leslie Gladney, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Pregnancy, Breastfeeding, Heart attack, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4-8 weeks

768 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia. The main questions it aims to answer are: * Is QuitAid, alone or combined with other quitting tobacco treatments, effective? * What makes QuitAid easy or hard to carry out? Is it cost effective? Is it easy to maintain? Treatment: All participants will be given at least 4 weeks of the nicotine patch. Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below). These groups will be compared to each other to see which combination works best to help them quit smoking. * Smokefree TXT - a texting program that helps people quit smoking * Tobacco quitline - 4 phone sessions to help people quit smoking * 8 weeks of NRT (nicotine replacement therapy in the form of nicotine patches or nicotine patches and lozenge) medication instead of 4 weeks * QuitAid - An MTM program given by the patient's pharmacist. This is a quitting smoking coaching program * Nicotine patch AND nicotine lozenge instead of just nicotine patches

Do I have to stop taking my current medications for the QuitAid trial?

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

Is QuitAid (nicotine replacement therapy) safe for humans?

Research indicates that nicotine replacement therapies, like nicotine lozenges and patches, are generally safe for humans. A study on over-the-counter nicotine patches found no serious adverse events, and another study on transdermal nicotine systems did not report significant safety concerns. ^{1 2 3 4 5}

How is the QuitAid treatment for quitting smoking different from other treatments?

QuitAid combines nicotine replacement therapies like lozenges and patches with support programs such as Smokefree TXT and Tobacco Quitline, offering a comprehensive approach that includes both medication and behavioral support, which may enhance the chances of successfully quitting smoking compared to using nicotine replacement alone. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment QuitAid for Quitting Smoking?

Research shows that nicotine replacement therapies, like patches and lozenges, can help people quit smoking. Studies have found that using these therapies, sometimes combined with telephone support, can improve the chances of successfully quitting smoking. ^{1 3 9 10 11}

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 smokers from rural areas in Virginia, Tennessee, Kentucky, and North Carolina who smoke at least 5 cigarettes daily for the past 6 months. Participants must be willing to quit within the next month, own a cell phone, and use nicotine replacement therapy (NRT). Pregnant individuals or those planning pregnancy are excluded.

Inclusion Criteria

I am willing to use nicotine replacement therapy via patch or lozenge.

Must not be pregnant or planning to be pregnant in the next 6 months

I am willing to commit to quitting smoking within the next 30 days.

Exclusion Criteria

Pregnant women (self-reported), breastfeeding, planning to become pregnant during the next 6 months

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

Treatment

Participants receive various combinations of nicotine replacement therapy, QuitAid, SmokefreeTXT, and Quitline interventions

4-8 weeks

Follow-up

Participants are monitored for quit attempts and tobacco abstinence

6 months

Follow-ups at 1, 2, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine lozenge
• Nicotine Lozenge
• Nicotine Replacement Therapy Patch
• QuitAid
• Smokefree TXT
• Tobacco Quitline

Trial Overview The study tests QuitAid—a pharmacist-led coaching program—to see if it helps people stop smoking when used alone or with other treatments like Smokefree TXT messages, Tobacco Quitline calls, and NRT patches or lozenges. Participants will receive different combinations of these treatments randomly to find out which is most effective.

How Is the Trial Designed?

Group I: QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Group II: QuitAid, 8 weeks, Patch, SmokeFree Txt Experimental Treatment 3 Interventions

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

Group III: QuitAid, 8 weeks, Patch, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention

Group IV: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine Experimental Treatment 5 Interventions

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

Group V: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt Experimental Treatment 4 Interventions

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

Group VI: QuitAid, 8 weeks, Patch + Lozenge, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention

Group VII: QuitAid, 8 weeks, Patch + Lozenge Experimental Treatment 3 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.

Group VIII: QuitAid, 8 weeks, Patch Experimental Treatment 2 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Group IX: QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Group X: QuitAid, 4 weeks, Patch, SmokeFree Txt Experimental Treatment 3 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.

Group XI: QuitAid, 4 weeks, Patch, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention

Group XII: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine Experimental Treatment 5 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Group XIII: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt Experimental Treatment 4 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.

Group XIV: QuitAid, 4 weeks, Patch + Lozenge, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention

Group XV: QuitAid, 4 weeks, Patch + Lozenge Experimental Treatment 3 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.

Group XVI: QuitAid, 4 weeks, Patch Experimental Treatment 2 Interventions

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Group XVII: 8 weeks, Patch, SmokeFree Txt, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Group XVIII: 8 weeks, Patch, SmokeFree Txt Experimental Treatment 2 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Group XIX: 8 weeks, Patch, QuitLine Experimental Treatment 2 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Group XX: 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Group XXI: 8 weeks, Patch + Lozenge, SmokeFree Txt Experimental Treatment 3 Interventions

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

Group XXII: 8 weeks, Patch + Lozenge, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Group XXIII: 8 weeks, Patch + Lozenge Experimental Treatment 2 Interventions

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Group XXIV: 8 weeks, Patch Experimental Treatment 1 Intervention

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Group XXV: 4 weeks, Patch, SmokeFree Txt, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Group XXVI: 4 weeks, Patch, SmokeFree Txt Experimental Treatment 2 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Group XXVII: 4 weeks, Patch, QuitLine Experimental Treatment 2 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Group XXVIII: 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine Experimental Treatment 4 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Group XXIX: 4 weeks, Patch + Lozenge, SmokeFree Txt Experimental Treatment 3 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.

Group XXX: 4 weeks, Patch + Lozenge, QuitLine Experimental Treatment 3 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Group XXXI: 4 weeks, Patch + Lozenge Experimental Treatment 2 Interventions

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Group XXXII: 4 weeks, Patch Experimental Treatment 1 Intervention

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

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

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 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]

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 randomized trial involving 509 smokers, combining a nicotine patch with telephone support did not significantly improve smoking cessation rates, with only 20% of participants remaining smoke-free after 12 months across all groups.

Despite the lack of impact from the telephone support, 92% of participants found the orientation session helpful, indicating that while the intervention may not have been effective, the educational component was valued.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy in a group model HMO. Rolnick, SJ., Klevan, D., Cherney, L., et al.[2016]

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 study of 186 participants, only 1.6% showed delayed contact sensitization to the nicotine transdermal system, indicating a low risk of allergic reactions.

The transdermal nicotine system was well tolerated, with less than 3% of applications causing nonallergic skin irritation, and all reactions resolved without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) Jordan, WP.[2015]

In a randomized controlled trial involving 854 smokers, adding telephone counselling to nicotine replacement therapy (NRT) significantly improved smoking cessation rates, with 28-day continuous abstinence at 3 months being 31.6% for the counselling group compared to 25.1% for NRT alone.

At 6 months, the counselling group also showed higher 90-day continuous abstinence rates (26.7% vs. 18.6%), demonstrating that telephone counselling effectively enhances the efficacy of NRT in helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. Macleod, ZR., Charles, MA., Arnaldi, VC., et al.[2020]

Participants who chose varenicline (3,116 individuals) for tobacco cessation had higher abstinence rates at both 3 months (22%) and 6 months (17%) compared to those using nicotine replacement therapy (NRT) (13% at 3 months and 11% at 6 months), indicating that varenicline may be more effective in supporting quitting.

The study found that factors such as increasing age, having health insurance, and the number of counseling sessions were associated with higher rates of abstinence, particularly at 3 months, suggesting that these factors could enhance the effectiveness of quitline services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

The Committed Quitters Program (CQP) significantly improved quit rates among smokers who actively used the program materials, with 38.8% abstinence at 6 weeks and 18.2% at 12 weeks, compared to 30.7% and 11.1% in the standard User's Guide (UG) group.

Overall abstinence rates did not differ significantly between the CQP and UG groups, indicating that the effectiveness of CQP is particularly notable among those who engage with the tailored materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. Shiffman, S., Paty, JA., Rohay, JM., et al.[2019]

Citations

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

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

2. 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]

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

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

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

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

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

Nicotine replacement therapy in a group model HMO. [2016]

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

Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) [2015]

9. Australia pubmed.ncbi.nlm.nih.gov

Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. [2020]

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

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

11. Ireland pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]