Treatment of Nicotine Dependence Among African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
研究概览
简要总结
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.
PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
详细描述
OBJECTIVES:
- Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers.
- Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence.
OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms.
- Arm I (standard care [SC]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date.
- Arm II (computer-delivered treatment [CDT]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date.
All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American
- •Age 21 to 65 years
- •Current Smoker (history of at least 5 cigarettes/day for the last year)
- •Motivated to quit within the next 14 days
- •Participants must provide a viable home address and functioning home telephone number
- •Can speak, read, write in English at a sixth-grade literacy level
- •Provide viable collateral contact information
- •Register "8" or more on a carbon monoxide breath test
排除标准
- •Contraindication for nicotine patch use
- •Active substance dependence (exclusive of nicotine dependence)
- •Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
- •Use of bupropion or nicotine products other than nicotine patches supplied by the study
- •Pregnancy or lactation
- •Any active illness that precludes full participation in the study protocol
- •Another household member enrolled in the study
研究组 & 干预措施
Standard Care Group
Written self-help materials, counseling, and 6-week nicotine patch supply
干预措施: Counseling intervention (Other)
Standard Care Group
Written self-help materials, counseling, and 6-week nicotine patch supply
干预措施: Nicotine patch (Drug)
Computer Treatment Group (CDT)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Smoking cessation intervention (Behavioral)
Computer Treatment Group (CDT)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Counseling intervention (Other)
Computer Treatment Group (CDT)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Nicotine patch (Drug)
CDT Pilot
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Smoking cessation intervention (Behavioral)
CDT Pilot
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Counseling intervention (Other)
CDT Pilot
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
时间窗: 6 months after treatment
Abstinence measures are collected at four post cessation follow-up visits. Point prevalence serving as the primary outcome measure. Primary outcome analyses will use data from all of the follow-up visits. SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings. The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications. The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits.
次要结局
- Contemplating smoking by Contemplation Ladder 6 months after treatment(6 months after treatment)