Tobacco Cessation Programs for Quitting Smoking

Overseen By David Goldfarb, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Albert Einstein College of Medicine

Must be taking: Varenicline

Must not be taking: Varenicline

Disqualifiers: Reduced renal function, Active cancer, 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

Compensation: Varies

Number of Visits: 31

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an Enhanced Care program can help smokers quit more effectively than usual methods. It compares two groups: one receives standard help to quit smoking, including the medication Varenicline (also known as Chantix or Champix), while the other receives a more personalized approach with tailored counseling and medication that starts before quitting. The trial focuses on high-risk smokers from the FDNY World Trade Center Health Program who have smoked for a long time or smoke heavily. Retired individuals enrolled in the FDNY program and currently smoking may be a good fit for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering an opportunity to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently using varenicline, you must stop at least 30 days before participating.

What is the safety track record for these treatments?

Research has shown that varenicline, a medication used in this trial, generally helps people quit smoking. However, some safety concerns exist. The FDA has noted that varenicline can cause side effects such as seizures, shaking, and possible interactions with alcohol. It may also increase the risk of certain heart problems in some individuals.

Despite these concerns, the FDA has approved varenicline for quitting smoking, indicating it is considered safe for most people when used as directed. Discuss personal risks with a healthcare provider, especially if existing health issues are present. Report any unusual symptoms while taking this medication. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for quitting smoking because they offer personalized and enhanced support options. The Enhanced Treatment arm stands out by using individually-tailored biofeedback linked to Chest CT and spirometry results, providing smokers with a more personalized understanding of their lung health. Unlike standard care, which typically involves opt-in counseling, the Enhanced Treatment uses an opt-out approach, potentially increasing participation rates. Both treatments incorporate varenicline, a medication shown to help people quit smoking, but the enhanced biofeedback and counseling methods aim to boost effectiveness beyond what traditional approaches offer.

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

Research has shown that personalized programs to help people stop smoking can be more effective than standard methods. One study found that these customized plans increase the chances of quitting. In this trial, participants in the Enhanced Treatment arm will receive personalized counseling combined with varenicline, which has been shown to help people quit smoking more effectively than a placebo. Studies indicate that varenicline helps people stay smoke-free for at least a year. Participants in the Standard Treatment arm will receive standard tobacco cessation counseling with varenicline. Combining personalized counseling with varenicline, as in the Enhanced Treatment arm, might increase the chances of quitting for good. ^{6 7 8 9 10}

Who Is on the Research Team?

David Goldfarb, PhD

Principal Investigator

FDNY

Shadi Nahvi, MD, MS

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for current smokers enrolled in the FDNY World Trade Center Health Program's lung cancer screening who have consented to research. It's not for those with recent psychiatric instability, pregnant or breastfeeding women, individuals with seizures, alcohol use disorders, or recent varenicline use.

Inclusion Criteria

Self-reported current smoker as of participants' most recent FDNY World Trade Center Health Program questionnaire

Enrolled in the FDNY World Trade Center Health Program Chest CT program

Previously provided informed consent to World Trade Center Health Program Research

Exclusion Criteria

I have not used varenicline in the last 30 days.

I have seizures.

Psychiatric instability (exacerbations in prior 3 months; current suicidal ideation or attempt, psych hospitalizations in past year)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Varenicline preloading regimen starting 4 weeks prior to target quit date

4 weeks

1 visit (in-person)

Treatment

Participants receive tobacco cessation counseling and varenicline treatment

12 weeks

Visits at baseline, weeks 2, 4, 8, 12, and 16

Follow-up

Participants are monitored for tobacco abstinence and retention post-treatment

12 weeks

Final assessment at 28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Care
• Standard Care
• Varenicline

Trial Overview

The study tests an Enhanced Care program against Standard Care at FDNY. Enhanced Care includes automatic enrollment and personalized counseling based on lung screening results plus early start of varenicline treatment. The goal is to see if this improves quit rates among high-risk smokers.

How Is the Trial Designed?

Group I: Enhanced Care Experimental Treatment 1 Intervention

Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date.

Group II: Standard Care Active Control 1 Intervention

Opt-in counseling enrollment. Standard tobacco cessation counseling. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

FDNY World Trade Center Health Program

Collaborator

Trials

1

Recruited

320+

National Institute for Occupational Safety and Health (NIOSH/CDC)

Collaborator

Trials

44

Recruited

50,000+

Published Research Related to This Trial

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 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 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 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 randomized controlled trial, varenicline (Chantix) demonstrated a higher abstinence rate from smoking after one year compared to both bupropion SR (Zyban) and a placebo, indicating its efficacy in treating tobacco dependence.

Despite its effectiveness, varenicline has been associated with serious neuropsychiatric side effects, highlighting the importance of discussing potential risks and benefits with patients considering this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). Rankin, KV., Jones, DL.[2015]

Varenicline, a medication used for smoking cessation, has been linked to serious cardiovascular events, including pulmonary thromboembolism (PTE), which may occur even in patients without pre-existing cardiovascular conditions.

A case report highlighted a probable association between varenicline and PTE, indicating that this adverse effect should be considered when prescribing the medication, especially since the patient had a low risk for such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking varenicline for smoking cessation: A rare cause of pulmonary thromboembolism with infarction. Lee, SH., Yun, SJ., Ryu, S., et al.[2017]

Varenicline (Champix) is a newly approved medication for smoking cessation that acts as a partial agonist of nicotinic receptors, offering a different mechanism of action compared to traditional therapies like nicotine replacement and bupropion.

Recent studies indicate that varenicline is effective in helping individuals quit smoking and may have advantages over existing treatments, although potential side effects are also discussed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug of the month. Varenicline (Champix)]. Vandemergel, X.[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]

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