Smoking
Conditions
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.
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
Sponsors
NYU Langone Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) | 12 months | 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, |
| Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quit attempts | 6 and 12 months | Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months |
| Change in self-reported abstinence from cigarettes | 6 and 12 months | Measured with self-reported abstinence from cigarettes at 6 months and at 12 months |
| Change in self-reported use of electronic nicotine delivery systems use | 6 and 12 months | Measured with self-reported use of electronic nicotine delivery systems use at 6 months and at 12 months |
Countries
United States
Contacts
CONTACTErin Rogers, DrPH
PRINCIPAL_INVESTIGATORErin Rogers, DrPH
NYU Langone Health
Outcome results
None listed