Tobacco Cessation Programs for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Overseen by Shadi Nahvi, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.

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.

Is varenicline safe for humans?

Varenicline, used for quitting smoking, has been linked to some safety concerns, including serious mental health side effects like depression and suicidal thoughts, as well as potential heart-related issues. It's important to discuss these risks with a healthcare provider before starting the treatment. ^{1 2 3 4 5}

How is the drug varenicline unique for quitting smoking?

Varenicline is unique because it is a selective partial agonist of the nicotinic acetylcholine receptor, which helps reduce cravings and withdrawal symptoms while blocking the rewarding effects of nicotine. This mechanism makes it different from other smoking cessation aids like nicotine replacement therapy and bupropion. ^{2 4 6 7 8}

Research Team

Shadi Nahvi, MD, MS

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

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.

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

I have seizures.

Trial Timeline

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

Treatment Details

Interventions

• Enhanced Care (Behavioural Intervention)
• Standard Care (Behavioural Intervention)
• Varenicline (Other)

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.

Participant Groups

Group I: Enhanced Treatment 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 Treatment 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+

Dr. Philip Ozuah

Albert Einstein College of Medicine

Chief Medical Officer since 2019

MD from University of Ibadan, Nigeria

Dr. Yaron Tomer

Albert Einstein College of Medicine

Chief Executive Officer since 2021

MD from Sackler School of Medicine, Tel Aviv University

FDNY World Trade Center Health Program

Collaborator

Trials

1

Recruited

320+

Findings from Research

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]

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 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]

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]

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 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]

References

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

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

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

Treatment of nicotine dependence with Chantix (varenicline). [2015]

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

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

4. 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]

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

Taking varenicline for smoking cessation: A rare cause of pulmonary thromboembolism with infarction. [2017]

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

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

7. Australia pubmed.ncbi.nlm.nih.gov

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

8. Belgium pubmed.ncbi.nlm.nih.gov

[Drug of the month. Varenicline (Champix)]. [2015]