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临床试验/NCT00861146
NCT00861146已完成2 期

Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Yale University3 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
151
试验地点
3
主要终点
Smoking Abstinence

研究概览

简要总结

The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.

详细描述

Objectives:

Most alcohol and drug treatment programs do not systematically address cigarette smoking during treatment. One obstacle is a concern that smoking cessation early in recovery might increase risk of alcohol relapse. This study followed patients enrolled in intensive outpatient alcohol treatment to compare the effects of a Concurrent Smoking Cessation (CSC) intervention to a Deferred Smoking Cessation (DSC) control group on process measures reflecting risk of alcohol relapse.

Research Design:

Participants were enrolled in intensive outpatient alcohol treatment and then randomized to CSC or DSC groups in a 2:1 ratio. The CSC group received smoking treatment concurrent with intensive alcohol treatment and the DSC group received smoking treatment three months after alcohol treatment. The smoking treatment protocol included behavioral counseling, contingency management with voucher rewards for verified smoking abstinence, and prescribed nicotine patch and gum. During a three-month period after the CSC target smoking quit date, both groups of subjects were asked to participate in a prospective daily monitoring procedure, calling into an Interactive Voice Response system once a day to complete self-report assessments of relapse risk factors. By comparing participants in the CSC group composed of many participants who have stopped smoking with the DSC group who are expected to continue smoking during this daily monitoring period, we will determine the impact of smoking cessation on alcohol relapse risk factors.

Methodology:

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
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

  • DSM-IV criteria for alcohol abuse or dependence
  • Age 18 or older
  • English speaking
  • Smoking 1 or more cigarettes/day
  • Male or female veterans eligible for VA healthcare
  • Female nonveterans also eligible

排除标准

  • Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
  • Weigh less than 100 lbs
  • Lack of interest in stopping smoking
  • Pregnant or lactating females or females not practicing acceptable form of contraception

结局指标

主要结局

Smoking Abstinence

时间窗: 2 weeks

7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

次要结局

  • Proportion of Days Heavy Drinking(follow-up weeks 9-12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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