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OpenTrials
Completed

NCT Number: NCT03620708

Tobacco and Socioeconomic Disadvantage

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Nicotine replacement therapy sampling

Drug

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.

Other names: Nicotine Replacement Therapy

Referral Only

Behavioral

Participants are provided with a written referral for tobacco dependence treatment.

Other names: Referral

Primary outcomes

  1. 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."

  2. 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 outcomes

  1. Self-reported Cigarettes Per Day

    Time frame: 30 days

    Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Addressing Tobacco Use Among Those At Socioeconomic Disadvantage

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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