QuitAid 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

Disqualifiers: Pregnancy, Breastfeeding, Heart attack, others

No Placebo Group

Trial Summary

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.

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 2 3 4 5}

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 3 6 7 8}

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 9 10 11}

Research Team

Melissa A Little, PhD,MPH

Principal Investigator

University of Virginia

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Nicotine lozenge (Nicotine Replacement Therapy)
• Nicotine Lozenge (Nicotine Replacement Therapy)
• Nicotine Replacement Therapy Patch (Nicotine Replacement Therapy)
• QuitAid (Behavioural Intervention)
• Smokefree TXT (Behavioural Intervention)
• Tobacco Quitline (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Nicotrol 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

Trials

802

Patients Recruited

1,342,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

References

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]