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临床试验/NCT00469885
NCT00469885已完成2 期

Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2001年1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
已完成
入组人数
152
试验地点
2
主要终点
Number of cigarettes per day

研究概览

简要总结

This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.

详细描述

This study randomly assigns smokers who do not have a quit date set to either a smoking reduction grop or usual care group. The smoking reduction group receives behavioral counseling on smoking reduction and nicotine patch and/or gum to reduce the number of cigarettes smoked per day by at least 50%. The usual care group is given brief advice to quit smoking and referral to local cessation services. To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily). Participants complete questionnaires that measure mood, functional ability, smoking history, and motivation to quit smoking. Participants will be followed in this study for up to 24 months.

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

  • To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily).

排除标准

  • 未提供

研究组 & 干预措施

1

Other

Usual care

干预措施: Motivational counseling (Behavioral)

2

Other

Reduction

干预措施: Nicotine replacement (Drug)

结局指标

主要结局

Number of cigarettes per day

时间窗: 6 months

ASCVD health changes

时间窗: 6 months

Number of quit attempts

时间窗: 6 months

Days of abstinence from cigarettes

时间窗: 6 months

次要结局

  • Withdrawal symptoms(ongoing through 6 months)

研究者

申办方类型
Nih

研究点 (2)

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