Health TrialsbyHealthPanel

Integrating Financial Coaching and Smoking Cessation Coaching

ConditionSmoking
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

people who know a current past study participant (to avoid intervention contamination)

allergy to nicotine patch

pregnancy or intention to become pregnant over the next 12 months

breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Financial counseling

    Other intervention

    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.

  • Nicotine Replacement Therapy Agent - Patches

    Drug

    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.

  • Nicotine Replacement Therapy Agent - Lozenges

    Drug

    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

  • Nicotine Replacement Therapy Agent - Gum

    Drug

    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

Treatment groups

602 Participants
are divided into 2 treatment groups
Group A: Standard Smoking Cessation CoachingActive comparator 3 interventions
Group B: Integrated Financial-Smoking Cessation CoachingExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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,

Time frame
12 months
2

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.

Time frame
12 months

Secondary outcomes

1

Change in quit attempts

Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months

Time frame
6 and 12 months
2

Change in self-reported abstinence from cigarettes

Measured with self-reported abstinence from cigarettes at 6 months and at 12 months

Time frame
6 and 12 months
3

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

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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