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NCT Number: NCT05154669

Integrating Financial Coaching and Smoking Cessation Coaching

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Erin Rogers, DrPH

CONTACT

[email protected]

646-501-2544

Erin Rogers, DrPH

PRINCIPAL_INVESTIGATOR

About this study

The study is a two-arm, parallel-group RCT. The study will recruit and randomize 900 low-income smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling. Both groups will receive 8 weeks of nicotine replacement therapy. The study will survey participants at baseline, 6 months, and 12 months to assess outcomes and mechanisms, and biochemically verify self-reported abstinence at 12 months (our primary outcome). The study will assess and compare the costs and cost-per-quit in the two treatment arms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Financial counseling

Other

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

Drug

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

Drug

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

Drug

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 outcomes

  1. Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)

    Time frame: 12 months

    The study will collect salivary cotinine from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a saliva collection kit supplied by Salimetrics Inc. Participants will be classified as negative for salivary cotinine if their concentration is <10ng/ml,

  2. Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration)

    Time frame: 12 months

    The study will collect exhaled CO from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a coVita Co monitor that provides an immediate CO concentration reading in single parts per million (ppm). Participants will be classified as negative for exhaled CO if their concentration is <8 ppm.

Secondary outcomes

  1. Change in quit attempts

    Time frame: 6 and 12 months

    Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months

  2. Change in self-reported abstinence from cigarettes

    Time frame: 6 and 12 months

    Measured with self-reported abstinence from cigarettes at 6 months and at 12 months

  3. Change in self-reported use of electronic nicotine delivery systems use

    Time frame: 6 and 12 months

    Measured with self-reported use of electronic nicotine delivery systems use at 6 months and at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Rogers, DrPH

CONTACT

[email protected]

646-501-2544

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Dec 13, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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