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NCT05997225 · ClinicalTrials.gov registry record · Phase 4

Tobacco Cessation at FDNY

A Phase 4 study, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
Phase 4
Development phase
23
Enrollment target

NCT05997225: Completed Phase 4 study, sponsored by Albert Einstein College of Medicine.

NCT05997225 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05997225, a Phase 4 study, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
23 participants
Enrollment target

Study Summary

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.

Primary Outcome

Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms. The number of participants who attend the first visit with the tobacco treatment specialist will be tabulated and reported.

Interventions

  • OTHER opt out enrollment, tailored counseling, varenicline started prior to target quit date
  • OTHER opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2024-05-31
Est. Completion 2025-10-13
Phase Phase 4
Albert Einstein College of Medicine

175 total trials

What the finished NCT05997225 record still lists

NCT05997225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which opt out enrollment, tailored counseling, varenicline started prior to target quit date is the first listed.

NCT05997225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05997225 about?

NCT05997225 is a clinical study titled "Tobacco Cessation at FDNY". 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 propos...

What is the current status of trial NCT05997225?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2024-05-31. Estimated completion is 2025-10-13.

What interventions are being tested in trial NCT05997225?

The interventions under investigation include: opt out enrollment, tailored counseling, varenicline started prior to target quit date (OTHER), opt in enrollment, non-tailored counseling, varenicline started prior to target quit date (OTHER).

Who is sponsoring clinical trial NCT05997225?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05997225's enrollment target sits among peer trials

23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05997225, the US trial registry maintained by the National Library of Medicine. NCT05997225 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.