Recruiting
Phase 3

Financial Coaching & Smoking Cessation

Sponsor:

NYU Langone Health

Code:

NCT05154669

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Financial counseling

Nicotine Replacement Therapy Agent - Patches

Nicotine Replacement Therapy Agent - Lozenges

Nicotine Replacement Therapy Agent - Gum

Study Details

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.

Conditions

Smoking

Study ID

NCT05154669

Start date

Dec 8, 2022

Status verified date

Apr, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

602 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Smoking Cessation Coaching

Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).

experimental: Integrated Financial-Smoking Cessation Coaching

The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).

Interventions

Financial counseling

The goals of the financial counseling will be to: (1) screen and refer participants to financial benefits and empowerment programs; (2) help participants create and maintain a household budget to meet short- and long-term goals; and (3) help participants link smoking cessation to their budgeting goals.

Nicotine Replacement Therapy Agent - Patches

24 hour dosing system that provides regular, measured nicotine to the bloodstream through the skin. Nicotine patches are available in 3 dosages: 21 mg, 14mg, and 7mg. Patches will be adjusted based on withdrawal symptoms, urges, and comfort. After 4-6 weeks of abstinence, taper ever 2-4 weeks in 7-14 mg steps as tolerated.

Nicotine Replacement Therapy Agent - Lozenges

General Info 24 hour dosing system that provides regular, measured nicotine to the bloodstream through the skin.

Provides regular, measured, amount of nicotine to the bloodstream through the mucous membranes of the mouth. As with the patch, the idea is to taper the amount of lozenges used until you no longer need it. Provides regular, measured, amount of nicotine to the bloodstream through the mucous membranes of the mouth. As with the patch and lozenge, the idea is to taper the amount of gum chewed until you no longer need it. Comes in 4mg or 2mg. Initial dosing is 1-2 lozenges every 1-2 hours (minimum of 9/day). Taper as tolerated

Nicotine Replacement Therapy Agent - Gum

Provides regular, measured, amount of nicotine to the bloodstream through the mucous membranes of the mouth. As with the patch and lozenge, the idea is to taper the amount of gum chewed until you no longer need it. Initial dosing is 1-2 pieces every 1-2 hours (10-12 pieces/day). Taper as tolerated

Primary outcome measure

  • Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) [ Time Frame: 12 months ]
  • Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Erin Rogers, DrPH

646-501-2544erin.rogers@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Erin Rogers, DrPH

646-501-2544erin.rogers@nyulangone.org

Principal Investigator:

Erin Rogers, DrPH

More Information

Sponsor

NYU Langone Health

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-04.