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Behavioural Intervention

Tobacco Cessation Programs for Quitting Smoking

Phase 4

Recruiting

Led By Shadi Nahvi, MD, MS

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the 12-week post eot timepoint at 28 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare two tobacco cessation programs for high-risk smokers to see which one works best. It will look at their enrollment and quitting rates.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Varenicline may cause headaches, nausea, sleep disturbances (like insomnia or vivid dreams), mood swings including depression and irritability; rarely it can lead to more serious side effects like heart issues or severe skin reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the 12-week post eot timepoint at 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the 12-week post eot timepoint at 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the 12-week post eot timepoint at 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment

Secondary study objectives

Counseling adherence

Retention to Study End-Date

Tobacco Abstinence

+1 more

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Agitation

21%

Depression

21%

Headache

14%

Heartburn

14%

Allergies

14%

Cold

14%

Back Pain

Confusion

Aggression

Panic

Stomach Pain

Dizziness

Fatigue

Leg Spasms

Sinusitis

Angina

Increased Blood Pressure

Palpitations

Cellulitis

Rash

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced TreatmentExperimental Treatment1 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 TreatmentActive Control1 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.

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