NCT05154669

Integrating Financial Coaching and Smoking Cessation Coaching

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	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.
DRUG	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.
DRUG	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
DRUG	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

Timeline

• Start date: 2022-12-08
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-12-13
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study