RecruitingPhase 3NCT05154669

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


Sponsor

NYU Langone Health

Enrollment

488 participants

Start Date

Dec 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria8

  • 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.

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Interventions

OTHERFinancial 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.

DRUGNicotine 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.

DRUGNicotine 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

DRUGNicotine 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


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05154669


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