Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Smoking Abstinence
研究概览
简要总结
The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.
详细描述
Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites.
Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others.
Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.
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
- 是
入选标准
- •African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening
排除标准
- •Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
研究组 & 干预措施
Counseling
Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.
干预措施: Smoking Cessation Counseling (Behavioral)
Counseling Plus NRT
Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.
干预措施: Nicotine Replacement Therapy (Drug)
Counseling Plus NRT
Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.
干预措施: Smoking Cessation Counseling (Behavioral)
结局指标
主要结局
Smoking Abstinence
时间窗: Week 12
Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.
次要结局
- Smoking Abstinence(Week 26)
- Concentration of Urinary Cotinine(Weeks 0, 26)
- Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)(Weeks 0, 12)
- Total Days Abstinent(Week 0-26)
- Cigarettes Used(Weeks 0-26)