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临床试验/NCT01550029
NCT01550029Unknown不适用

Targeted Intervention for Bipolar Smokers

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年7月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Prolonged Abstinence from Smoking
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

详细描述

All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.

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
否

入选标准

  • •Participants who are motivated to quit smoking
  • •Male or female
  • •18 years of age or older
  • •Diagnosed with bipolar disorder according to DSM-IV criteria
  • •Stable on medication with no significant changes in the last 3 months before enrollment.
  • •Smoking 10 cigarettes/day for the past 90 days

排除标准

  • •Healthy volunteers
  • •Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
  • •Not being and being treated with medication for the bipolar disorder

结局指标

主要结局

Prolonged Abstinence from Smoking

时间窗: Last four weeks of treatment period

Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.

次要结局

  • Prevalence of Abstinence from Smoking(Last 7 days of treatment period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Targeted Intervention for Bipolar Smokers | 临床试验