Nurse Practitioner-Led Smoking Cessation Program for Smoking

(STOP-NPT3 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Quinn Pack, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Baystate Medical Center

Disqualifiers: Pregnancy, Suicidal ideation, Hospice, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Tobacco use remains the leading cause of death in the United States and contributes to more than 7 million hospitalizations annually. Being admitted to the hospital offers the perfect opportunity to support smoking cessation. Patients are motivated to quit because of their current illness and societal guidelines recommend clinicians should counsel patients and prescribe smoking cessation pharmacotherapy (SCP) to virtually all smokers. However, only 22% of patients are prescribed SCP while hospitalized, and only 1% are prescribed medications compatible with current guidelines. This failure is part of the reason 70-80% of hospitalized smokers eventually relapse. The relapse typically occurs within a few days of hospital discharge - well before outpatient follow-up can occur. The investigators aim to improve smoking cessation treatment and guideline adherence by utilizing the opportunity that hospitalization provides. The investigators have created a tobacco treatment team (T3) to overcome physicians' and patients' low use of current guideline smoking cessation medications. The team members are trained in tobacco treatment and will be led by a nurse practitioner (NPT3). The team will work together and 1) prescribe individually tailored and guideline-concordant SCP; 2) counsel and motivate patients to use SCP properly; and 3) manage a mobile phone-based text-messaging system to keep patients motivated and adherent to SCP. Our preliminary data suggest that such an approach is workable and acceptable to patients, physicians, and hospital administrators. The investigators will recruit 424 patients in the hospital who smoke with cardiopulmonary disease. These patients will be randomized to receive either usual care or personalized care with the NPT3 team. The investigators will compare rates of guideline-concordant SCP use at 1 week and exhaled carbon monoxide (eCO) verified smoking cessation at 6 months between patients randomized to the NPT3 team vs. usual care. The investigators will also measure the project's economic value from a hospital and payer perspective. Understanding the economic value will better inform hospital and insurance policies and sustainability. Finally, acceptability, generalizability, and sustainability measures will be assessed through qualitative interviews with patients, providers, and hospital leadership.

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.

What data supports the effectiveness of the drug varenicline tartrate for smoking cessation?

Research shows that varenicline tartrate, also known as Chantix or Champix, is effective in helping people quit smoking. Studies have found it to be more effective than other therapies and safe for use in real-world settings. ^{1 2 3 4 5}

Is the Nurse Practitioner-Led Smoking Cessation Program using varenicline safe for humans?

Varenicline, used in smoking cessation programs, has been associated with some safety concerns, including potential neuropsychiatric side effects like depression and suicidal thoughts, as well as interactions with alcohol. However, it has been shown to have an acceptable safety profile in several studies, meaning it is generally considered safe for use in humans with these considerations in mind. ^{1 2 6 7 8}

How is the Nurse Practitioner Tobacco Treatment Team (NPT3) treatment for smoking cessation different from other treatments?

The Nurse Practitioner Tobacco Treatment Team (NPT3) is unique because it is led by nurse practitioners who provide personalized support and counseling, which can enhance the effectiveness of the smoking cessation process compared to standard treatments that may not include this level of personalized care. ^{1 9 10 11 12}

Research Team

Quinn Pack, MD

Principal Investigator

Baystate Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Peter Banko

Baystate Medical Center

Chief Executive Officer

MBA from Stanford University

Dr. Yvonne Cheung

Baystate Medical Center

Chief Medical Officer since 2024

MD from Columbia University, MPH from Harvard School of Public Health, MBA from University of Massachusetts Amherst

University of Massachusetts Chan Medical School, Worcester

Collaborator

Trials

3

Recruited

850+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

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

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015]

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

Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation: a placebo-controlled, randomized study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

8. New Zealand 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. [2021]

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

Women's Initiative for Nonsmoking (WINS V): under-use of nicotine replacement therapy. [2019]

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

A model nurse practitioner-managed smoking cessation clinic. [2004]

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

Using the Rx for Change tobacco curriculum in advanced practice nursing education. [2019]

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

The nurse practitioners' role in smoking cessation. [2019]