SmokingPhase 3NCT05154669
Integrating Financial Coaching and Smoking Cessation Coaching
A Phase 3 study testing Financial counseling, Nicotine Replacement Therapy Agent - Patches and Nicotine Replacement Therapy Agent - Lozenges in people with Smoking, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Financial counseling, Nicotine Replacement Therapy Agent - Patches and Nicotine Replacement Therapy Agent - Lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 1 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Erin Rogers, DrPH, 646-501-2544, erin.rogers@nyulangone.org
Erin Rogers, DrPH
About this study
Official title: Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Financial counseling, Nicotine Replacement Therapy Agent - Patches, Nicotine Replacement Therapy Agent - Lozenges, Nicotine Replacement Therapy Agent - Gum
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial counselingOther
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 - PatchesDrug
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 - LozengesDrug
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 - GumDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Financial counseling; Drug: Nicotine Replacement Therapy Agent - Patches; Drug: Nicotine Replacement Therapy Agent - Lozenges; Drug: Nicotine Replacement Therapy Agent - Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Change in quit attempts
Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months
Measured: 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
Measured: 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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start8 Dec 2022
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erin Rogers, DrPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154669
- Sponsor's protocol ID
- 21-00986
- Other IDs
- 1R01CA252483-01A1
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05154669
- Acronym / sponsor ID
- 21-00986
- Conditions
- Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Smoking Cessation Coaching | Active comparator | Drug: Nicotine Replacement Therapy Agent - Patches, Drug: Nicotine Replacement Therapy Agent - Lozenges, Drug: Nicotine Replacement Therapy Agent - GumParticipants 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). |
| Integrated Financial-Smoking Cessation Coaching | Experimental | Other: Financial counseling, Drug: Nicotine Replacement Therapy Agent - Patches, Drug: Nicotine Replacement Therapy Agent - Lozenges, Drug: Nicotine Replacement Therapy Agent - GumThe 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial counselingThe 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. | Other | Integrated Financial-Smoking Cessation Coaching |
| Nicotine Replacement Therapy Agent - Patches24 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 | Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching |
| Nicotine Replacement Therapy Agent - LozengesGeneral 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 | Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching |
| Nicotine Replacement Therapy Agent - GumProvides 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 | Drug | Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching |
Primary outcome
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,
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.
3 secondary outcomes
Change in quit attempts
Time frame: 6 and 12 months
Change in self-reported abstinence from cigarettes
Time frame: 6 and 12 months
Change in self-reported use of electronic nicotine delivery systems use
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Rogers, DrPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Financial counseling, Nicotine Replacement Therapy Agent - Patches and Nicotine Replacement Therapy Agent - Lozenges in people with Smoking, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Rogers, DrPH (646-501-2544, erin.rogers@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.