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临床试验/NCT03620708
NCT03620708已完成4 期

Addressing Tobacco Use Among Those At Socioeconomic Disadvantage

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
58
试验地点
1
主要终点
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The individual conducting the outcomes assessment is blind to study condition.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Motivational Interviewing

Experimental

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

干预措施: Motivational Interviewing (Behavioral)

Nicotine Replacement Therapy Sampling

Active Comparator

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.

干预措施: Nicotine Replacement Therapy Sampling (Drug)

Referral Only

Other

Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.

干预措施: Referral Only (Behavioral)

结局指标

主要结局

Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'

时间窗: 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'

时间窗: 30 days

Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment

次要结局

  • Importance, Confidence, & Readiness Questionnaire(30 days)
  • Self-reported Cigarettes Per Day(30 days)
  • Readiness to Quit Ladder(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc L. Steinberg, Ph.D.

Associate Professor

Rutgers, The State University of New Jersey

研究点 (1)

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