Clinical trial
Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial
Name
21-00986
Description
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.
Trial arms
Trial start
2022-12-08
Estimated PCD
2026-10-01
Trial end
2027-10-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Integrated Financial-Smoking Cessation Coaching
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.
Arms:
Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching
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 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
Arms:
Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching
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
Arms:
Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching
Size
121
Primary endpoint
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)
12 months
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 121, 'type': 'ESTIMATED'}}
Updated at
2023-10-26
1 organization
1 product
1 indication
Organization
NYU Langone HealthIndication
Tobacco use disorder