Smoking CessationPhase 4NCT03187730
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
A Phase 4 study testing Integrated Smoking Cessation and Financial Counseling, Waitlist Integrated Smoking Cessation and Financial Counseling and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Integrated Smoking Cessation and Financial Counseling, Waitlist Integrated Smoking Cessation and Financial Counseling and Nicotine Replacement Therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokes ≥5 cigarettes per day
- Born outside the U.S.
- Interested in receiving smoking and financial counseling
- Self-reported income below 200% of the current federal poverty level for a given household composition
- New York City resident
- English or Spanish language
Show all 10Show fewer
- Able to provide informed consent, and
- Does not have a representative who manages his/her funds (to ensure the participant has the ability to manage household money). We will exclude participants who report being pregnant or breastfeeding (unable to receive NRT).
- Hospital staff participants:
- Must be current medical or non-medical provider or administrator at Bellevue Hospital or New York University Lutheran Medical Center
Who cannot join
- We will exclude participants who report being pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.
Read the detailed description
This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.
- Conditions
- Smoking Cessation
- Being tested
- Integrated Smoking Cessation and Financial Counseling, Waitlist Integrated Smoking Cessation and Financial Counseling, Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking Cassation, Immigrants, Economic Disparity
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Smoking Cessation and Financial CounselingBehavioural
Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Waitlist Integrated Smoking Cessation and Financial CounselingBehavioural
Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT)Drug
Participants in both arms will be eligible to receive a free four-week supply of NRT.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Not described Receives: Behavioral: Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT) |
| Waitlist Control | Placebo comparator | Not described Receives: Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)
Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start22 Sep 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Rogers, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187730
- Sponsor's protocol ID
- 16-02177
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2017
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rogers ES, Wysota CN, Sherman SE. Banking Status as a Moderator of Outcomes in a Randomized Controlled Trial Targeting Financial Stress and Smoking. J Gen Intern Med. 2025 Dec 2. doi: 10.1007/s11606-025-10064-0. Online ahead of print.
PubMed 41331201Tempchin J, Vargas E, Sherman S, Rogers E. Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use. Prev Sci. 2023 Apr;24(3):525-534. doi: 10.1007/s11121-022-01416-x. Epub 2022 Aug 6.
PubMed 35932394Rogers ES, Rosen MI, Elbel B, Wang B, Kyanko K, Vargas E, Wysota CN, Sherman SE. Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial. J Gen Intern Med. 2022 Sep;37(12):2973-2981. doi: 10.1007/s11606-021-07209-2. Epub 2022 Jan 11.
PubMed 35018561
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
- ClinicalTrials.gov ID
- NCT03187730
- Acronym / sponsor ID
- 16-02177
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cassation, Immigrants, Economic Disparity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.
Detailed description
This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Behavioral: Integrated Smoking Cessation and Financial Counseling, Drug: Nicotine Replacement Therapy (NRT) |
| Waitlist Control | Placebo comparator | Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling, Drug: Nicotine Replacement Therapy (NRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Smokes ≥5 cigarettes per day
- Born outside the U.S.
- Interested in receiving smoking and financial counseling
- Self-reported income below 200% of the current federal poverty level for a given household composition
- New York City resident
Key exclusion criteria (1 listed)
- We will exclude participants who report being pregnant or 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 |
|---|---|---|
| Integrated Smoking Cessation and Financial CounselingParticipants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction. | Behavioural | Intervention Arm |
| Waitlist Integrated Smoking Cessation and Financial CounselingControl participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction. | Behavioural | Waitlist Control |
| Nicotine Replacement Therapy (NRT)Participants in both arms will be eligible to receive a free four-week supply of NRT. | Drug | Intervention Arm, Waitlist Control |
Primary outcome
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)
Time frame: 6 Months
Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41331201Rogers ES, Wysota CN, Sherman SE. Banking Status as a Moderator of Outcomes in a Randomized Controlled Trial Targeting Financial Stress and Smoking. J Gen Intern Med. 2025 Dec 2. doi: 10.1007/s11606-025-10064-0. Online ahead of print.
- Derived from this study: PubMed 35932394Tempchin J, Vargas E, Sherman S, Rogers E. Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use. Prev Sci. 2023 Apr;24(3):525-534. doi: 10.1007/s11121-022-01416-x. Epub 2022 Aug 6.
- Derived from this study: PubMed 35018561Rogers ES, Rosen MI, Elbel B, Wang B, Kyanko K, Vargas E, Wysota CN, Sherman SE. Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial. J Gen Intern Med. 2022 Sep;37(12):2973-2981. doi: 10.1007/s11606-021-07209-2. Epub 2022 Jan 11.
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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. This study is not recruiting at the moment.
Erin Rogers 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 4 study testing Integrated Smoking Cessation and Financial Counseling, Waitlist Integrated Smoking Cessation and Financial Counseling and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, 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 10 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2021. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187730, which also lists 3 linked publications.
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 18 Jun 2021.