Take a Break + NRT for Smoking Cessation

(TABR Trial)

Overseen By Anna M Thorpe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Actively quitting, Prisoners, NRT contraindications, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Take a Break + NRT for Smoking Cessation?

Research shows that nicotine replacement therapy (NRT), which includes options like nicotine gum, lozenges, and patches, can nearly double the chances of quitting smoking. Providing NRT starter kits in primary care settings has been found to be a practical and effective way to help smokers quit. ^{1 2 3 4 5}

Is nicotine replacement therapy (NRT) safe for humans?

Nicotine replacement therapy (NRT) is generally considered safe for humans, although some people may experience symptoms of nicotine toxicity if they reach high nicotine levels. These symptoms can include nausea, dizziness, and increased heart rate, but they are usually mild and manageable. ^{2 3 6 7 8}

How is the Take a Break + NRT treatment different from other smoking cessation treatments?

The Take a Break + NRT treatment is unique because it combines a behavioral intervention ('Take a Break') with Nicotine Replacement Therapy (NRT), which includes options like nicotine gum, lozenges, patches, inhalers, and mouth spray. This combination aims to address both the physical addiction to nicotine and the behavioral aspects of smoking, potentially offering a more comprehensive approach to quitting smoking compared to using NRT alone. ^{7 9 10 11 12}

What is the purpose of this trial?

The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.

Research Team

Rajani Sadasivam, PhD

Principal Investigator

UMass Chan Medical School

Thomas K Houston, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for current smokers over 18 years old who speak English, are not ready to quit smoking but can read texts and have a text-enabled phone. It's not for prisoners, those unwilling to consent, actively quitting or planning to quit within a month, or with contraindications to nicotine replacement therapy.

Inclusion Criteria

Speaks English

Not yet ready to quit smoking

Current Smoker

Exclusion Criteria

Actively quitting smoking

Preparing to quit smoking within 30 days

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a novel program in rural counties using community paramedicine to engage lower-motivated smokers

4 years

Monthly visits for training and support

Treatment

Participants receive the Take a Break intervention with nicotine replacement therapy, including motivational text messages, challenge quizzes, and coping mini-games

6 months

Follow-up

Participants are monitored for smoking cessation and effectiveness of the intervention

6 months

Treatment Details

Interventions

• Community Paramedicine Standard Implementation Program
• Community Paramedicine Standard Plus Enhanced Implementation Program
• Take a Break plus Nicotine replacement therapy (NRT) Sampling
• The Comparison

Trial Overview The study tests new programs in rural areas aimed at increasing access to tobacco control services for smokers not yet ready to quit. It compares 'Take a Break' plus Nicotine Replacement Therapy sampling against standard community paramedicine programs with varying levels of implementation support.

Participant Groups

Group I: The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling Experimental Treatment 1 Intervention

Motivational text messages, challenge quizzes, goal-setting, coping mini-games, and recognition \& rewards. Nicotine lozenges will be given to all participants in both randomized groups.

Group II: The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program Experimental Treatment 1 Intervention

The Enhanced Program will include strategies described in the Standard Program plus training of local champions.

Group III: The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break Active Control 1 Intervention

Nicotine lozenges will be given to all participants in both randomized groups. The goal of the comparison group is to isolate the effect of the Take a Break experience.

Group IV: The Standard Program: Community Paramedicine Standard Implementation Program Active Control 1 Intervention

The standard program will include training, resources, and access to the e-refer tool.

Take a Break plus Nicotine replacement therapy (NRT) Sampling is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nicotine replacement therapy (NRT) for:

• Smoking cessation

Approved in European Union as Nicotine replacement therapy (NRT) for:

• Smoking cessation

Approved in Canada as Nicotine replacement therapy (NRT) for:

• Smoking cessation

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Findings from Research

A study involving 750 smokers and ex-smokers in Geneva led to the development of the Attitudes Toward Nicotine Replacement Therapy scale (ANRT-12), which effectively measures perceptions of the benefits and drawbacks of nicotine replacement therapy (NRT).

Despite NRT's proven effectiveness in doubling quit rates, the study revealed that many smokers and ex-smokers hold negative attitudes towards it, with only 16% believing it helps people quit smoking, indicating a need for better education and awareness about NRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. Etter, JF., Perneger, TV.[2022]

In a study involving 1245 adult smokers across 22 primary care clinics, providing a 2-week starter kit of nicotine replacement therapy (NRT) significantly increased smoking abstinence rates at 6 months (12% vs. 8%) compared to standard care alone.

The NRT sampling not only boosted the use of nicotine replacement products (65% vs. 25%) but also led to a higher rate of quit attempts in the first month (24% vs. 18%), demonstrating its effectiveness in supporting smokers to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial. Carpenter, MJ., Wahlquist, AE., Dahne, J., et al.[2023]

Nicotinell lozenges, particularly the 1 mg formulation, have been shown to be bioequivalent to 2 mg nicotine gum, providing effective nicotine delivery for smoking cessation, with significant short-term efficacy demonstrated in over 900 smokers.

The lozenges have an excellent safety profile, with only mild and reversible adverse events reported, making them a safe option for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). Dautzenberg, B., Nides, M., Kienzler, JL., et al.[2023]

The ongoing trial is testing the effectiveness of adding nicotine replacement therapy (NRT) sampling to standard care for smokers in primary care settings, aiming to improve smoking cessation rates.

With 22 clinics involved and a diverse patient population, the study will assess the impact of NRT on quit attempts and treatment uptake over six months, potentially enhancing the effectiveness of brief interventions in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial. Dahne, J., Wahlquist, AE., Boatright, AS., et al.[2023]

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., 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]

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 review of 28 clinical trials involving 7,120 participants, only 10.5% experienced a significant increase in cotinine levels (>50% above baseline) while using nicotine replacement therapy (NRT), indicating that high nicotine exposure is relatively uncommon.

Adverse events related to nicotine overdose, such as nausea, vomiting, and palpitations, were reported infrequently (0.2% to 0.5% of subjects), supporting the overall safety of NRT for smoking cessation or reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Tonstad, S., Gustavsson, G., Kruse, E., et al.[2018]

Nicotine replacement therapy (NRT) significantly increases the chances of quitting smoking by 50% to 60%, based on a systematic review of 136 studies involving 64,640 participants, demonstrating its effectiveness across various forms like gum, patches, and sprays.

While NRT can cause minor side effects such as skin irritation and mouth discomfort, serious adverse events are extremely rare, indicating that NRT is a safe option for those trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy versus control for smoking cessation. Hartmann-Boyce, J., Chepkin, SC., Ye, W., et al.[2022]

Nicotine replacement therapy (NRT) significantly increases the chances of quitting smoking, with a risk ratio of 1.58 compared to placebo, based on a review of 132 trials involving over 40,000 participants.

All forms of NRT (gum, patches, nasal spray, inhalers, and tablets) are effective, with the highest effectiveness seen in nicotine inhalers and nasal sprays, and combining different forms of NRT can enhance quitting success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy for smoking cessation. Stead, LF., Perera, R., Bullen, C., et al.[2023]

Nicotine replacement therapy (NRT) significantly increases the chances of quitting smoking, with an odds ratio of 1.72 compared to control, and is effective across various forms including gum, patches, and nasal sprays, regardless of the level of additional support provided.

While all forms of NRT are effective, the study suggests that bupropion may be more effective than NRT alone or in combination, indicating that alternative pharmacotherapies could enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy for smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2018]

In a study involving 100 smokers, the combination of a nicotine inhaler and fluoxetine did not significantly improve smoking cessation rates compared to a nicotine inhaler and placebo, with sustained abstinence rates being similar across both groups.

Fluoxetine may be beneficial for smokers with higher depression scores, as it appeared to increase abstinence rates in this subgroup, suggesting that antidepressants could help specific populations when quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of fluoxetine combined with nicotine inhalers in smoking cessation--a randomized trial. Blondal, T., Gudmundsson, LJ., Tomasson, K., et al.[2019]

References

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

Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]

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

Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial. [2023]

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

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy versus control for smoking cessation. [2022]

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

Nicotine replacement therapy for smoking cessation. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy for smoking cessation. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The effects of fluoxetine combined with nicotine inhalers in smoking cessation--a randomized trial. [2019]