A Phase 3 interventional study of Financial counseling and Nicotine Replacement Therapy Agent - Patches in Smoking, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by NYU Langone Health · Phase 3, Interventional, and Treatment
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.
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.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's planned enrollment of 602 is above the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria
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
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
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.
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.
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
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
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,
Time frame: 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.
Time frame: 12 months
Change in quit attempts
Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months
Time frame: 6 and 12 months
Change in self-reported abstinence from cigarettes
Measured with self-reported abstinence from cigarettes at 6 months and at 12 months
Time frame: 6 and 12 months
Change in self-reported use of electronic nicotine delivery systems use
Measured with self-reported use of electronic nicotine delivery systems use at 6 months and at 12 months
Time frame: 6 and 12 months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap
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