Tobacco Cessation at FDNY
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| ClinicalTrials.gov Identifier: NCT05997225 |
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Recruitment Status :
Not yet recruiting
First Posted : August 18, 2023
Last Update Posted : April 1, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tobacco Use Tobacco Smoking Tobacco Use Cessation | 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 | Phase 4 |
The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.
The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders participating in the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Preventing Lung Cancer Through Tobacco Cessation at FDNY |
| Estimated Study Start Date : | April 2024 |
| Estimated Primary Completion Date : | September 2025 |
| Estimated Study Completion Date : | September 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Enhanced Treatment
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. |
Other: opt out enrollment, tailored counseling, varenicline started prior to target quit date
Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants. |
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Active Comparator: Standard Treatment
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. |
Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results. |
- Enrollment [ Time Frame: 28 weeks ]Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms.
- Retention [ Time Frame: 28 weeks ]Number of participants retained to study end-date
- Varenicline adherence [ Time Frame: week 16 ]Assessed via electronic medication monitoring: pills taken / pills prescribed
- Counseling adherence [ Time Frame: week 28 ]Adherence with number of counseling visits attended as a continuous variable
- Tobacco abstinence [ Time Frame: end of treatment (16 weeks) ]7-day point prevalence abstinence biochemically verified by urine cotinine < 30 ng/mL
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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:
- use of varenicline in past 30 days
- psychiatric instability (exacerbations in prior 3 months; current suicidal ideation or attempt, psych hospitalizations in past year)
- seizures
- pregnancy or breast feeding.
- alcohol use disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997225
| Contact: Shadi Nahvi, MD, MS | 718 920 5379 | shadi.nahvi@einsteinmed.edu | |
| Contact: David Goldfarb, PhD | 718 403 4413 | david.goldfarb@fdny.nyc.gov |
| United States, New York | |
| FDNY World Trade Center Health Program | |
| Brooklyn, New York, United States, 11201 | |
| Contact: David Goldfarb, PhD 718-403-4413 | |
| Principal Investigator: | Shadi Nahvi, MD, MS | Albert Einstein College of Medicine |
| Responsible Party: | Albert Einstein College of Medicine |
| ClinicalTrials.gov Identifier: | NCT05997225 |
| Other Study ID Numbers: |
2023-14980 |
| First Posted: | August 18, 2023 Key Record Dates |
| Last Update Posted: | April 1, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Deidentified data set |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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World Trade Center Health Program occupational medicine tobacco cessation lifestyle medicine opt-out treatment |
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Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |