Integrating Financial Coaching and Smoking Cessation Coaching

NYU Langone Health

Status and phase: Enrolling; Phase 3

Conditions: Smoking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05154669

21-00986

1R01CA252483-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 488 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

488 participants in 2 patient groups

Standard Smoking Cessation Coaching

Active Comparator group

Description:

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).

Treatment:

Drug: Nicotine Replacement Therapy Agent - Lozenges

Drug: Nicotine Replacement Therapy Agent - Patches

Drug: Nicotine Replacement Therapy Agent - Gum

Integrated Financial-Smoking Cessation Coaching

Experimental group

Description:

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).

Treatment:

Drug: Nicotine Replacement Therapy Agent - Lozenges

Drug: Nicotine Replacement Therapy Agent - Patches

Drug: Nicotine Replacement Therapy Agent - Gum

Other: Financial counseling