Nurse Practitioner-Led Smoking Cessation Program for Smoking

(STOP-NPT3 Trial)

Overseen By Karen L Riska, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baystate Medical Center

Disqualifiers: Pregnancy, Suicidal ideation, Hospice, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: During hospital stay

424 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better methods to help hospitalized patients quit smoking, particularly those with heart or lung issues. A special team led by a nurse practitioner provides personalized treatment and support, including medication and motivational counseling. The trial compares this approach, called the Nurse Practitioner Tobacco Treatment Team (NPT3), to usual care to determine which is more effective for long-term smoking cessation. Eligible participants include English-speaking patients admitted to Baystate Medical Center with heart-related issues like heart attacks or lung conditions like COPD who smoke. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and the use of smoking cessation pharmacotherapy (SCP), so it's best to discuss your current medications with the trial team.

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

Research has shown that varenicline, a medication often used to help people quit smoking, is generally safe. However, some studies have noted possible side effects, such as mood changes or unusual dreams. One study found varenicline to be as safe for smokers with HIV as for those without, although some people stopped using it due to these side effects.

Another study examined safety data and found slightly more psychiatric hospitalizations among varenicline users compared to those using nicotine replacement therapy (NRT), with 18 hospitalizations for varenicline users and 16 for NRT users. This suggests that while side effects can occur, they are not very common.

Overall, varenicline is usually well-tolerated, but awareness of these potential side effects is important. If concerns arise, especially regarding mood changes or other unusual symptoms while taking the medication, consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse Practitioner Tobacco Treatment Team (NPT3) because it offers a personalized care approach, unlike the standard options such as nicotine replacement therapies or prescription medications. The unique aspect of NPT3 is its focus on nurse practitioner-led interventions, which provide tailored support and guidance for individuals looking to quit smoking. This hands-on, personalized care could potentially lead to higher success rates in smoking cessation by addressing individual patient needs more effectively. Additionally, the involvement of nurse practitioners in delivering these treatments can enhance accessibility and provide continuous support, making the quitting process more manageable for participants.

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

Research shows that a team led by a nurse practitioner can help smokers quit more successfully. In this trial, participants will be randomized to receive either Enhanced Usual Care (EUC) or the Nurse Practitioner Tobacco Treatment Team (NPT3) intervention. Studies have found that medications like varenicline, also known as Chantix, effectively help people stop smoking. Specifically, varenicline has doubled the chances of quitting compared to other methods. This approach combines medication with counseling, enhancing its effectiveness. Personalized care and ongoing support, such as text messages, also motivate individuals to remain smoke-free. ^{1 3 6 7 8}

Who Is on the Research Team?

Quinn Pack, MD

Principal Investigator

Baystate Medical Center

Are You a Good Fit for This Trial?

This trial is for patients admitted to Baystate Medical Center in Springfield, MA with heart or lung diseases who smoke cigarettes. Participants must speak English and not be pregnant, nursing, planning hospice care, have a life expectancy under 6 months, current suicidal thoughts, or use daily smoked marijuana.

Inclusion Criteria

I have a history of heart or severe lung conditions treated at Baystate Medical Center.

I am admitted to Baystate Medical Center with a heart or lung condition.

You smoke cigarettes.

Exclusion Criteria

My doctors expect I have less than 6 months to live.

Pregnant or nursing women

You are currently thinking about hurting yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either enhanced usual care or personalized care with the Nurse Practitioner led Tobacco Treatment Team (NPT3) during hospitalization

During hospital stay

Inpatient care

Post-discharge Monitoring

Participants are monitored for smoking cessation medication adherence and smoking status through a mobile phone-based text-messaging system

6 months

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including smoking cessation outcomes and adverse events

Up to 3 years

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care (EUC)
• Nurse Practitioner Tobacco Treatment Team (NPT3)

Trial Overview The study tests if a Nurse Practitioner-led Tobacco Treatment Team (NPT3) can improve smoking cessation over Enhanced Usual Care (EUC) in hospitalized smokers with cardiopulmonary disease. It measures the use of smoking cessation pharmacotherapy and checks for non-smoking status at 1 week and after 6 months using breath analysis.

How Is the Trial Designed?

Group I: Personalized Care: Nurse Practitioner led Tobacco Treatment Team (NPT3) Experimental Treatment 1 Intervention

The investigators will administer the personalized care NPT3 intervention to randomized patients.

Group II: Enhanced usual care (EUC) Active Control 1 Intervention

The investigators will administer the enhanced usual care intervention to randomized patients.

Nurse Practitioner Tobacco Treatment Team (NPT3) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chantix for:

• Smoking cessation
• Dry eye disease

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

University of Massachusetts Chan Medical School, Worcester

Collaborator

Trials

3

Recruited

850+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

In a study involving 142 women with cardiovascular disease, only 9% to 22% reported using nicotine replacement therapy (NRT) during follow-up, indicating a low utilization rate despite its recommendation in a nurse-managed smoking cessation program.

The findings suggest a need for further research to address misconceptions about NRT among women, as nurses can play a crucial role in educating patients to help prevent smoking relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Initiative for Nonsmoking (WINS V): under-use of nicotine replacement therapy. Mahrer-Imhof, R., Froelicher, ES., Li, WW., et al.[2019]

Most smokers desire to quit, highlighting the potential for effective intervention in smoking cessation.

Nurse practitioners can play a crucial role in helping individuals quit smoking by initiating both individual and group therapy programs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nurse practitioners' role in smoking cessation. Christman, C., Bingham, M.[2019]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

In a study of 139 long-term nicotine replacement therapy users, varenicline combined with counseling significantly improved the quit rate at 12 weeks (64.3% for varenicline vs. 40.6% for placebo), indicating its efficacy in helping users stop NRT.

Participants taking varenicline experienced lower withdrawal symptoms compared to those on placebo, suggesting that varenicline not only aids in quitting but also makes the process more comfortable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Tønnesen, P., Mikkelsen, K.[2015]

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]

In a real-world study involving 566 participants across four European countries, varenicline was found to be an effective smoking cessation aid, with a 64.6% quit rate by the end of the 12-week treatment period.

The safety profile of varenicline was acceptable, with the most common side effects being mild to moderate nausea (8.9%) and insomnia (2.9%), and only 3.4% of participants discontinued due to treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Boudrez, H., Gratziou, C., Messig, M., et al.[2015]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

An intensive nurse practitioner-managed smoking cessation clinic was established in a large teaching hospital, effectively utilizing both behavioral and pharmacologic therapies to achieve high cessation rates among patients.

The clinic's success demonstrates that experienced nurses can lead smoking cessation efforts, providing a model that can be replicated in various healthcare settings to combat smoking-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model nurse practitioner-managed smoking cessation clinic. Andrews, JO., Tingen, MS., Harper, RJ.[2004]

A pilot study at Georgetown University showed that a 6-hour training program for advanced practice nursing students significantly improved their knowledge and confidence in helping patients quit tobacco.

The 'Rx for Change' curriculum demonstrates the importance of targeted training for healthcare providers to effectively support tobacco cessation efforts among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Rx for Change tobacco curriculum in advanced practice nursing education. Kelley, FJ., Heath, J., Crowell, N.[2019]

In a 24-week study involving 333 participants from China, Singapore, and Thailand, varenicline was found to be significantly more effective than placebo for smoking cessation, with 50.3% of participants achieving 4-week continuous abstinence compared to 31.6% in the placebo group.

Varenicline was safe and well tolerated, showing no significant side effects, which supports its use as a viable option for helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation: a placebo-controlled, randomized study. Wang, C., Xiao, D., Chan, KP., et al.[2022]

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.

While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Kasliwal, R., Wilton, LV., Shakir, SA.[2021]

In a study of 392 adult patients with smoking-related illnesses, those who received varenicline tartrate plus Quitline-counselling had a significantly higher continuous smoking abstinence rate at 104 weeks (29.2%) compared to those who only received counselling (18.8%).

This research is the first to evaluate the long-term efficacy and safety of varenicline tartrate in an inpatient setting, demonstrating its effectiveness as a treatment for smokers admitted with tobacco-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial. Carson-Chahhoud, KV., Smith, BJ., Peters, MJ., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05733767

Smoking Cessation Pharmacotherapy-Nurse Practitioner ... The investigators have created a tobacco treatment team (T3) to overcome physicians' and patients' low use of current guideline smoking cessation medications.

2. withpower.com withpower.com/trial/phase-4-pulmonary-heart-disease-10-2022-25b6a

Nurse Practitioner-Led Smoking Cessation Program for Smoking What data supports the effectiveness of the drug varenicline tartrate for smoking cessation? Research shows that varenicline tartrate, also known as Chantix ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824380/

Varenicline for smoking cessation: a narrative review of ... Clinical trials have consistently demonstrated that varenicline is a safe and effective agent for smoking cessation.

4. bmjopen.bmj.com bmjopen.bmj.com/content/6/1/e009381

Effectiveness of varenicline and counselling for smoking ... Conclusions Varenicline prescription in the smoking cessation clinic appeared to be effective with doubling of quit rates in Chinese smokers in a real world ...

5. researchgate.net researchgate.net/publication/341037405_Two-year_efficacy_of_varenicline_tartrate_and_counselling_for_inpatient_smoking_cessation_STOP_study_A_randomized_controlled_clinical_trial

Two-year efficacy of varenicline tartrate and counselling for ... PDF | Introduction Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3242617/

Safety and Tolerability of Varenicline Tartrate (Champix®/ ... In summary, varenicline was as safe in HIV-infected smokers as in HIV-negative smokers, although AEs were common and occasionally resulted in drug cessation.

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-chantix-varenicline-and-risk-neuropsychiatric

Safety review update of Chantix (varenicline) and risk ... In the DoD study's propensity score matched samples, there were 18 psychiatric hospitalizations among Chantix users and 16 among NRT users. A ...

8. muschealth.org muschealth.org/health-professionals/progressnotes/2024/summer/smoking-cessation

First U.S. trial of varenicline for e-cigarette cessation shows ... The results showed a significant disparity between the placebo group and the group receiving the medication. “We had a 15% difference in quit rates, with those ...