Tobacco and Socioeconomic Disadvantage

Study Overview
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Brief Summary
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Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.

Detailed Description
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The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.

Official Title
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Addressing Tobacco Use Among Those At Socioeconomic Disadvantage

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Drug: Nicotine Replacement Therapy Sampling
* Behavioral: Referral Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be between the age of 19 and 65 Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading >5) Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, Elijah's Promise) Participants must be able to speak and read English. Exclusion Criteria: Participants may not be taking FDA approved smoking cessation or anti-psychotic medications Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days) Participants may not report pending legal issues with potential to result in incarceration. Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial in which participants are randomized to one of three groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line | Behavioral: Motivational Interviewing<br>* Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.<br>|
| Active Comparator: Nicotine Replacement Therapy Sampling<br>Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. | Drug: Nicotine Replacement Therapy Sampling<br>* Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.<br>* Other names: Nicotine Replacement Therapy;|
| Other: Referral Only<br>Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. | Behavioral: Referral Only<br>* Participants are provided with a written referral for tobacco dependence treatment.<br>* Other names: Referral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' | A self-described serious attempt to quit smoking cigarettes since the initial study appointment, measured by the Quitting Preparation and Actions Questionnaire. | 30 days | 
| Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' | Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Cigarettes Per Day | Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm | 30 days | 
| Importance, Confidence, & Readiness Questionnaire | Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, & Readiness Questionnaire (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit) | 30 days | 
| Readiness to Quit Ladder | Readiness to Quit Ladder (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, smoking, cigarette