Tobacco and Socioeconomic Disadvantage

Overview

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

Full Title of Study: “Addressing Tobacco Use Among Those At Socioeconomic Disadvantage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2018

Detailed Description

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.

Interventions

  • Behavioral: Motivational Interviewing
    • 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.
  • Drug: Nicotine Replacement Therapy Sampling
    • 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.
  • Behavioral: Referral Only
    • Participants are provided with a written referral for tobacco dependence treatment.

Arms, Groups and Cohorts

  • Experimental: Motivational Interviewing
    • 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
  • Active Comparator: Nicotine Replacement Therapy Sampling
    • 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.
  • Other: Referral Only
    • Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Self-reported Cigarettes Per Day
    • Time Frame: 30 days
    • Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm
  • Importance, Confidence, & Readiness Questionnaire
    • Time Frame: 30 days
    • 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)
  • Readiness to Quit Ladder
    • Time Frame: 30 days
    • “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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc L. Steinberg, Ph.D., Associate Professor – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Marc L Steinberg, Ph.D., Principal Investigator, Rutgers Robert Wood Johnson Medical School

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