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?

This trial tests different methods to help people quit smoking, focusing on a program called QuitAid. Pharmacists lead QuitAid, which can be used alone or with other treatments, such as nicotine replacement therapy patches or special quit-smoking texts. The trial aims to determine which approach is most effective and easiest to use long-term. Eligible participants are smokers from rural areas in Virginia, Tennessee, Kentucky, and North Carolina who smoke at least five cigarettes a day and are ready to quit within 30 days. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance smoking cessation methods for many.

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

Previous studies have shown that nicotine replacement therapy (NRT), including nicotine patches and lozenges, is generally safe. However, some users of nicotine patches have reported skin irritation, which occurs more frequently than in non-users. Nicotine lozenges have also been well tolerated, with research indicating their general safety.

The QuitAid program, involving pharmacist-managed medication, has been tested for its effectiveness in helping people quit smoking. Although detailed safety data is unavailable, pharmacist-led support is considered helpful and easily accessible for smoking cessation.

The Smokefree TXT program, which sends supportive text messages, and the Tobacco Quitline, offering phone support, have both been found safe in similar programs. These services provide additional help without major safety concerns.

Overall, the treatments in the QuitAid trial have been well studied and are usually safe, with mild skin irritation from the nicotine patch being the most common side effect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the QuitAid protocol for quitting smoking because it combines traditional nicotine replacement therapies with innovative support strategies. Unlike standard options like nicotine patches or lozenges alone, QuitAid integrates medication therapy management by pharmacists, personalized text messaging support, and access to a Quitline for added behavioral support. This multi-faceted approach not only addresses the physical addiction to nicotine but also offers comprehensive emotional and psychological support, potentially leading to higher success rates in quitting smoking.

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

Research has shown that nicotine replacement therapy (NRT) can double the chances of quitting smoking. In this trial, participants may receive treatments such as the nicotine patch and lozenge, which significantly increase quit rates, especially for heavy smokers. Studies suggest that using these tools together helps more people remain smoke-free for longer. Participants may also receive support from the Smokefree TXT program, which sends motivational text messages to aid quitting, and Quitlines, which provide phone support and have improved success rates when combined with medication. QuitAid, another option in this trial, is a pharmacist-led program offering personalized guidance, though its effectiveness is still under study. ^{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 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

Must be able to read, speak, and understand English

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

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 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]

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 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 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]

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]

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]

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 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 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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/211489

Efficacy of a Nicotine Lozenge for Smoking Cessation The odds of being abstinent after 6 weeks of treatment were 2.1 to 3.7 times greater among those receiving the active lozenge (2- and 4-mg doses ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3174063/

A Comparison of the Nicotine Lozenge and Nicotine Gum ... At 8 weeks, successful quitters in the lozenge group gained 3.0 ± 6.3 lbs compared to the gum group which gained 8.4 ± 9.2 lbs with t= −2.4, p= 0.02, but this ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00985985

Efficacy and Safety Study of Nicotine Mint Lozenge (2mg ... Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels. From baseline to Week 6. Secondary Outcome Measures ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12038945/

Efficacy of a nicotine lozenge for smoking cessation Results: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547204001278

The effectiveness of nicotine patch and nicotine lozenge in ... Nicotine patch and lozenge significantly increased 6-month continuous abstinence quit rates in both very heavy (≥40 cigarettes per day) and highly dependent ( ...

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9GLAXC_NICORETTE_LOZ_MINI_MINT_2MG_20_BX.pdf

SAFETY DATA SHEET Not available. NICOTINE (CAS 54-11-5) Can be absorbed through the skin. General ventilation normally adequate. Personal protection equipment ...

7. haleonhealthpartner.com haleonhealthpartner.com/en-us/respiratory-health/brands/nicotine-replacement-therapy/nicorette-lozenges/safety-information/

Nicorette Lozenges Safety Information The Nicorette Lozenge was found to be well tolerated1​​ Safety was evaluated in a randomized, double-blind, placebo-controlled clinical trial over 52 weeks.

8. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=991704ed-781a-489b-8b56-0b558e8fc385

Label: NICORETTE- nicotine polacrilex lozenge - DailyMed Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it ...

9. nicorette.com nicorette.com/shop/lozenge/classic-lozenge/?srsltid=AfmBOop0zFct7skmqKkZ50wAJCWD77vUKu7iqBPkvRJvWIGhrl9mWmRl

Nicorette ® Classic Lozenge Mint Solid lozenges that slowly dissolve in your mouth with a hint of cool mint flavor, releasing therapeutic nicotine. A great choice to help ease cravings anytime.

10. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/n/nicorettecooldrops.pdf

Data Sheet NICORETTE® Cooldrops Lozenge should be used with caution in patients with moderate to severe hepatic impairment as the clearance of nicotine or its metabolites ...