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.
12345Is 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.
13678How 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.
1391011Eligibility 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.
+4 more
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
Participant Groups
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.
32Treatment groups
Experimental Treatment
Group I: QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment4 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 TxtExperimental Treatment3 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, QuitLineExperimental Treatment3 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, QuitLineExperimental Treatment5 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 TxtExperimental Treatment4 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, QuitLineExperimental Treatment4 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 + LozengeExperimental Treatment3 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, PatchExperimental Treatment2 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, QuitLineExperimental Treatment4 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 TxtExperimental Treatment3 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, QuitLineExperimental Treatment3 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, QuitLineExperimental Treatment5 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 TxtExperimental Treatment4 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, QuitLineExperimental Treatment4 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 + LozengeExperimental Treatment3 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, PatchExperimental Treatment2 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, QuitLineExperimental Treatment3 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 TxtExperimental Treatment2 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, QuitLineExperimental Treatment2 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, QuitLineExperimental Treatment4 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 TxtExperimental Treatment3 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, QuitLineExperimental Treatment3 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 + LozengeExperimental Treatment2 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
Group XXIV: 8 weeks, PatchExperimental Treatment1 Intervention
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
Group XXV: 4 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment3 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 TxtExperimental Treatment2 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, QuitLineExperimental Treatment2 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, QuitLineExperimental Treatment4 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 TxtExperimental Treatment3 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, QuitLineExperimental Treatment3 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 + LozengeExperimental Treatment2 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
Group XXXII: 4 weeks, PatchExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
References
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.
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.
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.
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.
Nicotine replacement therapy in a group model HMO. [2016]To examine patient response to a smoking cessation program that combined a nicotine replacement system (patch) with telephone support.
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.
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.
Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) [2015]Transdermal nicotine therapy has shown promise as a smoking cessation aid, but questions about its contact sensitization potential and long-term topical safety have been raised. The purpose of this study was to determine the contact sensitization potential of one nicotine transdermal system (Nicoderm, Marion Merrell Dow Inc, Kansas City, Mo, and ALZA Corporation, Palo Alto, Calif) in a population who were allowed to continue smoking.
Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. [2020]To investigate the effectiveness of telephone counselling as an adjunct to nicotine replacement therapy (NRT) by transdermal patch in smoking cessation.
Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]Telephone counseling through quitlines combined with cessation medication is an effective strategy to support tobacco cessation. This study assessed the characteristics of quitline enrollees selecting varenicline (Chantix) compared with nicotine replacement therapy (NRT) medication and evaluated the cessation outcomes (7-day point prevalence) among these enrollees at 3 and 6 months after program completion.
The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]The study evaluated the efficacy of the Committed Quitters Program (CQP), a computer-tailored set of printed behavioral support materials offered free to purchasers of NicoDerm CQ patches, as a supplement to the nicotine patch and the standard brief User's Guide (UG) and audiotape. Callers to the CQP enrollment were randomized to either CQP (n=1854) or just the UG (n=1829). Abstinence and use of program materials were assessed by telephone interview at 6 and 12 weeks (the latter falling 2 weeks after patch use was to be discontinued). Considering all respondents, abstinence rates did not differ significantly between the UG and CQP groups. As expected, among those who reported they used their assigned materials (80.1% of the sample) smokers who received CQP demonstrated higher quit rates at both 6 weeks (38.8% v. 30.7%) and 12 weeks (18.2% v. 11.1%), compared to the UG group. Among those who used it, the Committed Quitters Program proved to be an effective behavioral treatment, improving quit rates over nicotine replacement therapy and a brief untailored written guide and audiotape.