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临床试验/NCT02360631
NCT02360631已完成4 期

Advancing Tobacco Use Treatment for African American Smokers

Lisa Sanderson Cox, PhD2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年7月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Number of Participants With Smoking Abstinence at Month 6

研究概览

简要总结

The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

详细描述

To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking >10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.

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
Double (Participant, Investigator)

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

  • Self-identified African American
  • Smokes ≥ 1 cigarette per day (cpd)
  • Smoke on ≥ 25 days of the past 30 days
  • Functioning telephone
  • Interested in quitting smoking
  • Interested in taking 3 months of varenicline
  • Willing to complete all study visits

排除标准

  • Renal impairment
  • Evidence or history of clinically significant allergic reactions to varenicline
  • A cardiovascular event in the past month
  • History of alcohol or drug dependence in the past year
  • Major depressive disorder in the last year requiring treatment
  • History of panic disorder, psychosis, bipolar disorder, or eating disorders
  • Use of tobacco products other than cigarettes in past 30 days
  • Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
  • Pregnant, contemplating getting pregnant, or breastfeeding
  • Plans to move from Kansas City during the treatment and follow-up phase
  • Another household member enrolled in the study
  • Evidence of current severe major depressive disorder or suicidal ideation

研究组 & 干预措施

Chantix (varenicline)

Experimental

Participants will receive 1mg pills to take twice a day for 12 weeks.

干预措施: Chantix (Drug)

Placebo

Placebo Comparator

Participants will receive a placebo pill to take twice a day for 12 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants With Smoking Abstinence at Month 6

时间窗: Month 6

Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit

次要结局

  • Number of Participants With Smoking Abstinence at Week 12(Week 12)
  • Number of Participants With Smoking Abstinence at Week 26(Week 26)

研究者

发起方
Lisa Sanderson Cox, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lisa Sanderson Cox, PhD

Research Associate Professor

University of Kansas Medical Center

研究点 (2)

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