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Behavioural Intervention

Tobacco Cessation Programs for Quitting Smoking

Phase 4

Waitlist Available

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 week 28

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment

Secondary outcome measures

Counseling adherence

Retention

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%

Depression

21%

Agitation

21%

Headache

14%

Allergies

14%

Heartburn

14%

Cold

14%

Back Pain

Cellulitis

Sinusitis

Stomach Pain

Panic

Angina

Aggression

Palpitations

Rash

Confusion

Dizziness

Fatigue

Leg Spasms

Increased Blood Pressure

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

FDNY World Trade Center Health ProgramUNKNOWN

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,761 Total Patients Enrolled

Shadi Nahvi, MD, MSPrincipal InvestigatorAlbert Einstein College of Medicine

1 Previous Clinical Trials

243 Total Patients Enrolled

Media Library

Enhanced Care (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05997225 — Phase 4

Tobacco Use Research Study Groups: Standard Treatment, Enhanced Treatment

Tobacco Use Clinical Trial 2023: Enhanced Care Highlights & Side Effects. Trial Name: NCT05997225 — Phase 4

Enhanced Care (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997225 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Enhanced Treatment?

"Enhanced Treatment has received a safety rating of 3 due to its status as an approved Phase 4 trial."

Answered by AI

Is enrollment open for this investigation?

"According to the clinicaltrials.gov platform, this trial is no longer recruiting patients; it was initially published on November 1st 2023 and updated lastly on August 10th 2023. Nevertheless, there are over a hundred other studies that need volunteers at present."

Answered by AI