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NCT05154669PHASE3RecruitingAccepts Healthy Volunteers

Integrating Financial Coaching and Smoking Cessation Coaching

NYU Langone Health

Start Date

12/8/2022

Completion Date

12/1/2029

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.

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.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * 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 Criteria * 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.

Interventions

OTHER

Financial counseling

DRUG

Nicotine Replacement Therapy Agent - Patches

DRUG

Nicotine Replacement Therapy Agent - Lozenges

DRUG

Nicotine Replacement Therapy Agent - Gum

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Conditions

Smoking

Locations

NYU Langone Health

New York, New York 10016

United States