Integrating Financial Coaching and Smoking Cessation Coaching

Official title

Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial

Overview

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.

Interventions

• Other Financial 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.
• Drug Nicotine 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.
• Drug Nicotine 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 c
• Drug Nicotine 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

Primary outcome measures

• Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) [Time frame: 12 months]
• Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration) [Time frame: 12 months]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT05154669 · 21-00986 · 1R01CA252483-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗