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临床试验/NCT04501016
NCT04501016尚未招募2 期

A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Iowa City Veterans Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Tobacco cessation

研究概览

简要总结

Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.

详细描述

Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
  • Be willing to make a quit attempt in the next 30 days
  • Able to provide informed consent
  • Have access to a telephone
  • Have a stable residence,

排除标准

  • Planning to move within the next 6 months
  • Terminal illness
  • Unstable psychiatric disorder (e.g., acute psychosis)

研究组 & 干预措施

Tailored Intervention

Experimental

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

干预措施: Tailored behavioral counseling (Behavioral)

Tailored Intervention

Experimental

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

干预措施: Tobacco cessation pharmacotherapy (Drug)

结局指标

主要结局

Tobacco cessation

时间窗: 6 months

7-day point prevalence tobacco cessation

次要结局

  • Tobacco cessation(3 months)
  • Salivary cotinine levels (in ng/ml)(6 months)

研究者

发起方
Iowa City Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Mark Vander Weg

Core Investigator

Iowa City Veterans Affairs Medical Center

研究点 (1)

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