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Recruiting Phase 3 NCT05154669

NCT05154669 Integrating Financial Coaching and Smoking Cessation Coaching

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Plain-language summary for patients
Clinical Trial Summary
NCT ID NCT05154669
Status Recruiting
Phase Phase 3
Sponsor NYU Langone Health
Condition Smoking
Study Type INTERVENTIONAL
Enrollment 602 participants
Start Date 2022-12-08
Primary Completion 2029-12-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 100 Years
Study Type INTERVENTIONAL
Interventions
Financial counselingNicotine Replacement Therapy Agent - PatchesNicotine Replacement Therapy Agent - Lozenges

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 602 participants in total. It began in 2022-12-08 with a primary completion date of 2029-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.

Eligibility Criteria

Inclusion Criteria: * age ≥18 years, * smokes ≥5 cigarettes per day, * interested in receiving smoking and financial counseling, * self-reported income below 200% of the current federal poverty level, * New York City resident, * speaks English or Spanish language (the interventions and measures have not been validated in other languages), * able to provide informed consent, and * does not have a representative who manages his/her funds. Exclusion Criteria * people who know a current past study participant (to avoid intervention contamination) * People who have a medical contraindication to using nicotine replacement therapy: * allergy to nicotine patch * pregnancy or intention to become pregnant over the next 12 months * breastfeeding * heart attack in the past 2 months * underlying arrhythmia * ongoing or worsening angina.

Contact & Investigator

Central Contact

Erin Rogers, DrPH

✉ erin.rogers@nyulangone.org

📞 646-501-2544

Principal Investigator

Erin Rogers, DrPH

PRINCIPAL INVESTIGATOR

NYU Langone Health

Frequently Asked Questions

Who can join the NCT05154669 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05154669 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 602 participants.

Is NCT05154669 currently recruiting?

Yes, NCT05154669 is actively recruiting participants. Contact the research team at erin.rogers@nyulangone.org for enrollment information.

Where is the NCT05154669 trial being conducted?

This trial is being conducted at New York, United States.

Who is sponsoring the NCT05154669 clinical trial?

NCT05154669 is sponsored by NYU Langone Health. The principal investigator is Erin Rogers, DrPH at NYU Langone Health. The trial plans to enroll 602 participants.

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