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临床试验/NCT05513872
NCT05513872招募中1 期

A Mechanistic Test of Treatment Strategies to Foster Practice Quitting

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2023年3月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
780
试验地点
2
主要终点
Any incidence of a quit attempt

研究概览

简要总结

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly.

One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Although a growing body of evidence supports the role of practice quitting in fostering permanent quit attempts and cessation, there is a significant knowledge gap regarding which treatment strategies should be used to engage smokers in practice quitting. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none.

详细描述

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly.

One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Practice quitting represents a useful treatment exercise, as it offers a point of focus for behavior change coaching and goal-setting, with or without a planned quit date. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none. Specific aims are to:

Aim 1: Evaluate hypothesized mechanisms of action for PQ counseling and NRT sampling on incidence of quit attempts by 6 months among current smokers who are not planning to quit in the next 30 days (N=780). We will test the mediational effect of each variable on the relationship between PQ-focused treatment and incidence of quit attempts.

Aim 2: Test both the individual and combined roles of PQ counseling and NRT sampling on incidence of quit attempts by 6 months. We hypothesize that PQ counseling combined with NRT sampling will produce the highest rates of quit attempts through an additive relationship between these two treatment components.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Eligible participants will be males and females who:
  • are 18 years or older
  • report current daily cigarette smoking (≥ 5 cigarettes per day)
  • are not planning to quit in the next 30 days
  • are not currently engaged in smoking cessation treatment
  • are motivated to quit or engage in a non-cessation goal (i.e., reduce smoking, learn more about treatment options, and/ or try out skills to change smoking) in the next 6 months
  • are English speaking
  • reside in the continental United States
  • have access to a smartphone that can be used to complete study procedures

排除标准

  • Participants will be excluded for daily vaping/ electronic cigarettes use (i.e., use for ≥ 25 days within past 30 days) and any FDA contraindications for NRT use if they:
  • are pregnant/breastfeeding
  • had recent cardiovascular trauma such as myocardial infarction
  • had a stroke within the past 3 months

研究组 & 干预措施

Condition #1

Experimental

NRT Sampling = On Behavioral Counseling = Practice Quitting

干预措施: Nicotine Replacement Therapy (NRT) Sampling (Drug)

Condition #2

Experimental

NRT Sampling = Off Behavioral Counseling = Practice Quitting

干预措施: Practice Quitting (PQ) Counseling (Behavioral)

Condition #3

Experimental

NRT sampling = On Behavioral counseling = Motivational Interviewing

干预措施: Nicotine Replacement Therapy (NRT) Sampling (Drug)

Condition #3

Experimental

NRT sampling = On Behavioral counseling = Motivational Interviewing

干预措施: Motivational Interviewing (MI) Counseling (Behavioral)

Condition #1

Experimental

NRT Sampling = On Behavioral Counseling = Practice Quitting

干预措施: Practice Quitting (PQ) Counseling (Behavioral)

Condition #4

Experimental

NRT sampling = Off Behavioral counseling = Motivational Interviewing

干预措施: Motivational Interviewing (MI) Counseling (Behavioral)

结局指标

主要结局

Any incidence of a quit attempt

时间窗: At 6-month follow-up assessment

Intentional abstinence of ≥ 24 hours between the end of treatment and the 6-month follow-up assessment

次要结局

  • Abstinence status at 1-month follow-up(At 1-month follow-up assessment)
  • Abstinence status at 3-month follow-up(At 3-month follow-up assessment)
  • Abstinence status at 6-month follow-up(At 6-month follow-up assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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