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临床试验/NCT02905656
NCT02905656已完成不适用

Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit (PACE)

University of Virginia1 个研究点 分布在 1 个国家目标入组 903 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
903
试验地点
1
主要终点
Point Prevalence Tobacco Abstinence

研究概览

简要总结

To our knowledge, no study has evaluated the independent effects of motivational interviewing and rate reduction, individually versus in combination, for motivating smokers who are not ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence. Given the disseminability and the fact that findings can be readily translated into the network of tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ, following methods that we have previously implemented and evaluated (HL-123978, CA-127964); (2) To randomize 828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources (control group); (b) motivational interviewing format recommended by the Clinical Practice Guidelines; (c) behavioral and pharmacologic rate reduction, and (d) both motivational interviewing and behavioral and pharmacologic rate reduction. This design allows us to evaluate the independent and additive effects of motivational interviewing and rate reduction on quit attempts and smoking cessation.

We plan to evaluate the efficacy of the intervention utilizing point prevalence at the 12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper concluded that point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials. Prolonged abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the 12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction, tobacco dependence, intentions, motivation, and confidence to quit, and intervention adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested as important treatment mediators.

详细描述

On the Society for Research in Nicotine and Tobacco definition of a cessation induction trial, which is a treatment that promotes cessation among all smokers, including those not ready to quit.1 One implication of this design is that success is based on percent abstinent at a given point in time and do not tie a follow-up to a determined quit date (since smokers not ready to quit often don't typically set formal quit dates).

Investigators research led to a four condition treatment design as the main independent variable of interest. Participants will be randomly assigned to four treatment conditions: (1) Brief advice; (2) motivational interviewing; (3) rate reduction; and (4) combination of motivational interviewing and rate reduction. All four intervention conditions will receive three sessions once a week, ideally, but can extend to a 6 week time period, each approximately 30 minutes in length, provided over a period of 4 to 6 weeks, depending on the participant's circumstances. Upon the completion of the main components, Booster sessions will be administered in 2-month increments throughout the intervention period (2 month, 4 month, & 6 month follow-up) in conjunction with study assessments. The window for the Booster sessions will be as indicated above 2M, 4M, and 6M after enrollment, but we will continue to try and reach them to complete the booster session for 4 weeks. For example, 2 month booster window opens at 8 weeks after enrollment and we will try to complete that 2 month booster within 4 weeks. Twelve months after randomization, prolonged abstinence will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

  • Able to understand English
  • For the past 12 months, has smoked 5 or more cigarettes a day
  • 18 years or older
  • Planning on Quitting smoking someday
  • Access to a telephone
  • Willing and able to use NRT in the form of gum
  • Not currently using chantix or wellbutrin

排除标准

  • Planning to quit smoking cigarettes in the next 30 days
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  • Currently using chantix or wellbutrin
  • Diagnosed with an unstable heart condition

研究组 & 干预措施

Brief Advice

Placebo Comparator

Participants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity.

干预措施: Brief Advice (Behavioral)

Motivational Interviewing (MI)

Experimental

Motivational interviewing (MI) is a collaborative conversation style for strengthening a person's own motivation and commitment to change. MI attempts to avoid a confrontational style and, instead, guides participants toward choosing to make a change in their behavior.

干预措施: Motivational Interviewing (Behavioral)

Rate Reduction (RR)

Experimental

Participants will be informed of the strong medical evidence of systematic reductions in smoking behavior can lead to long-term smoking cessation. This condition will receive Nicotine Replacement Therapy in the form of gum.

干预措施: Rate Reduction (Behavioral)

Rate Reduction (RR)

Experimental

Participants will be informed of the strong medical evidence of systematic reductions in smoking behavior can lead to long-term smoking cessation. This condition will receive Nicotine Replacement Therapy in the form of gum.

干预措施: Pharmacological (Drug)

MI + RR

Experimental

In this intervention, participants receive both the skills based rate reduction intervention and the more motivationally based MI intervention. This condition will receive Nicotine Replacement Therapy in the form of gum.

干预措施: Pharmacological (Drug)

MI + RR

Experimental

In this intervention, participants receive both the skills based rate reduction intervention and the more motivationally based MI intervention. This condition will receive Nicotine Replacement Therapy in the form of gum.

干预措施: MI+RR (Behavioral)

结局指标

主要结局

Point Prevalence Tobacco Abstinence

时间窗: 12 months from randomization

Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.

次要结局

  • Prolonged Tobacco Abstinence(12 months from randomization)

研究者

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

Robert Klesges

Professor, Public Health Sciences

University of Virginia

研究点 (1)

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