Integrating Financial Coaching and Smoking Cessation Coaching

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Other: Financial counseling
* Drug: Nicotine Replacement Therapy Agent - Patches
* Drug: Nicotine Replacement Therapy Agent - Lozenges
* Drug: Nicotine Replacement Therapy Agent - Gum


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Smoking Cessation Coaching<br>Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). | Drug: Nicotine Replacement Therapy Agent - Patches<br>* 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.<br>Drug: Nicotine Replacement Therapy Agent - Lozenges<br>* 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<br>Drug: Nicotine Replacement Therapy Agent - Gum<br>* 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<br>|
| Experimental: Integrated Financial-Smoking Cessation Coaching<br>The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). | Other: Financial counseling<br>* 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.<br>Drug: Nicotine Replacement Therapy Agent - Patches<br>* 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.<br>Drug: Nicotine Replacement Therapy Agent - Lozenges<br>* 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<br>Drug: Nicotine Replacement Therapy Agent - Gum<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) | The study will collect salivary cotinine from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a saliva collection kit supplied by Salimetrics Inc. Participants will be classified as negative for salivary cotinine if their concentration is <10ng/ml, | 12 months | 
| Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration) | The study will collect exhaled CO from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a coVita Co monitor that provides an immediate CO concentration reading in single parts per million (ppm). Participants will be classified as negative for exhaled CO if their concentration is <8 ppm. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quit attempts | Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months | 6 and 12 months | 
| Change in self-reported abstinence from cigarettes | Measured with self-reported abstinence from cigarettes at 6 months and at 12 months | 6 and 12 months | 
| Change in self-reported use of electronic nicotine delivery systems use | Measured with self-reported use of electronic nicotine delivery systems use at 6 months and at 12 months | 6 and 12 months |