NCT03187730

Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

Completed Phase 4 Results posted Last updated 18 June 2021

What this trial tests

Phase 4 trial testing Integrated Smoking Cessation and Financial Counseling in Smoking Cessation in 410 participants. Completed in 30 April 2021.

Timeline

22 September 2017

Primary endpoint
30 April 2019

30 April 2021

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	410
Start date	22 September 2017
Primary completion	30 April 2019
Estimated completion	30 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Integrated Smoking Cessation and Financial Counseling
• Waitlist Integrated Smoking Cessation and Financial Counseling
• Nicotine Replacement Therapy (NRT) (nicotine-replacement-therapy-nrt) — full drug profile →

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) Primary · 6 Months

Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm

Group	Value	95% CI
Intervention Arm	27
Waitlist Control	13

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 11/208 (5%)

Deaths: 3/208

Waitlist Control

Serious: 5/202 (2%)

Deaths: 1/202

Serious adverse events (1 terms)

Reaction	System	Intervention Arm	Waitlist Control
Hospitaliztion	General disorders	—	—

Most-reported serious reactions: Hospitaliztion.

Data from ClinicalTrials.gov NCT03187730 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial.
   Rogers ES, Rosen MI, Elbel B, Wang B, et al · · 2022 · cited 12× · PMID 35018561 · DOI 10.1007/s11606-021-07209-2
2. Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use.
   Tempchin J, Vargas E, Sherman S, Rogers E. · · 2023 · cited 1× · PMID 35932394 · DOI 10.1007/s11121-022-01416-x
3. Banking Status as a Moderator of Outcomes in a Randomized Controlled Trial Targeting Financial Stress and Smoking.
   Rogers ES, Wysota CN, Sherman SE. · · 2025 · PMID 41331201 · DOI 10.1007/s11606-025-10064-0