Integrating Financial Coaching and Smoking Cessation Coaching

NCT05154669 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 21-009861R01CA252483-01A1
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  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,

  12 months

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

  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.

  12 months

Secondary Outcomes (3)

• Change in quit attempts

  6 and 12 months

• Change in self-reported abstinence from cigarettes

  6 and 12 months

• Change in self-reported use of electronic nicotine delivery systems use

  6 and 12 months

Study Arms (2)

Standard Smoking Cessation Coaching

ACTIVE COMPARATOR

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).

Drug: Nicotine Replacement Therapy Agent - Patches; Drug: Nicotine Replacement Therapy Agent - Lozenges; Drug: Nicotine Replacement Therapy Agent - Gum

Integrated Financial-Smoking Cessation Coaching

EXPERIMENTAL

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).

Other: Financial counseling; Drug: Nicotine Replacement Therapy Agent - Patches; Drug: Nicotine Replacement Therapy Agent - Lozenges; Drug: Nicotine Replacement Therapy Agent - Gum

Interventions

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.

Integrated Financial-Smoking Cessation Coaching

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.

Integrated Financial-Smoking Cessation Coaching; Standard Smoking Cessation Coaching

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

Integrated Financial-Smoking Cessation Coaching; Standard Smoking Cessation Coaching

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

Integrated Financial-Smoking Cessation Coaching; Standard Smoking Cessation Coaching

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Erin Rogers, DrPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Rogers, DrPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: December 8, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to ERIN.ROGERS@NYULANGONE.ORG. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)