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临床试验/NCT04297332
NCT04297332终止不适用

Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1
主要终点
Latency to relapse

研究概览

简要总结

This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.

详细描述

PRIMARY OBJECTIVE:

I. To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.

OUTLINE: Participants are randomized to 1 of 4 arms.

ARM I: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

ARM II: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
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

  • Smoke >= 8 cigarettes daily
  • Planning to quit in the next 14 days
  • No regular use of other tobacco products
  • Access to the internet
  • In possession of a smartphone with text messaging capabilities
  • In possession of an email address accessible at least every other day

排除标准

  • Unable or unwilling to provide consent
  • Unable to provide data to the research team after the quit date
  • Current use of bupropion or varenicline
  • Drinking >= 20 alcoholic drinks per week
  • Use of drugs of abuse in the past 30 days
  • Living in the same household as a participant already enrolled in this study

研究组 & 干预措施

Arm II (active EFT, control FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Informational Intervention (Other)

Arm I (active EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Behavioral Intervention (Behavioral)

Arm I (active EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Informational Intervention (Other)

Arm I (active EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Telephone-Based Intervention (Other)

Arm II (active EFT, control FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Behavioral Intervention (Behavioral)

Arm II (active EFT, control FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Nicotine Replacement (Drug)

Arm II (active EFT, control FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Telephone-Based Intervention (Other)

Arm III (control EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Behavioral Intervention (Behavioral)

Arm III (control EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Informational Intervention (Other)

Arm III (control EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Nicotine Replacement (Drug)

Arm III (control EFT, active FTP)

Experimental

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

干预措施: Telephone-Based Intervention (Other)

Arm IV (control EFT, control TFP)

Active Comparator

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

干预措施: Behavioral Intervention (Behavioral)

Arm IV (control EFT, control TFP)

Active Comparator

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

干预措施: Informational Intervention (Other)

Arm IV (control EFT, control TFP)

Active Comparator

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

干预措施: Nicotine Replacement (Drug)

Arm IV (control EFT, control TFP)

Active Comparator

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

干预措施: Telephone-Based Intervention (Other)

结局指标

主要结局

Latency to relapse

时间窗: Baseline, assessed up to 12 weeks

Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.

Change in Delay discounting rate

时间窗: Baseline, and 4 and 12 weeks after quit date

Assessed with the 5-Trial Adjusting Delay Discounting.

次要结局

  • Self-control(Up to 12 weeks)
  • Latency to first relapse(up to 12 weeks)
  • 7-day point prevalence abstinence rates(At 4 and 12 weeks after quit date)
  • Number of days abstinent(Up to 12 weeks)
  • Attentional, motor, and non-planning impulsiveness(Up to 12 weeks)
  • Behavioral inhibition and behavioral activation(Up to 12 weeks)
  • Ability to regulate behavior to achieve goals(Up to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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