Helping African American Light Smokers Quit

帮助非洲裔美国轻度吸烟者戒烟

• 批准号: 6641091
• 负责人: Jasjit Singh Ahluwalia
• 金额: $ 61.93万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-21 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6641091
• 关键词: African American; clinical research; clinical trials; drug addiction; health education; human subject; human therapy evaluation; longitudinal human study; mental disorder prevention; nicotine; patient oriented research; placebos; psychotherapy; racial /ethnic difference; respiratory therapy; smoking; smoking cessation; substance abuse related behavior; tobacco abuse; tobacco abuse education; urban area

Cigarette smoking is the leading preventable cause of disease and death for all Americans. African Americans (AAs) continue to have a high prevalence of smoking, up to 50 percent among the urban poor. Enabling them to quit smoking is a national health priority. In the United States, smoking cessation efforts have focused primarily on heavy smokers and excluded light smokers (smoke s10 cigarettes per day). However, up to 50 percent of African American (AA) smokers are light smokers. Despite smoking fewer cigarettes a day, AAs extract more nicotine per cigarette smoked, and have higher tobacco- related morbidity and mortality. Using a nicotine inhaler may help smokers quit; however, it has not been studied among light smokers. Because light smokers constitute a large proportion of AA smokers, it is critical that cessation interventions, including pharmacological aids and counseling strategies, be developed to include AA light smokers. The primary aim of this study is to assess the efficacy of nicotine inhaler and motivational interviewing for smoking cessation among inner-city AA light smokers. This randomized, placebo-controlled study will be conducted at a community-based clinic, Swope Parkway Health Center, in Kansas City, Missouri. The primary outcome of the study is biochemically-verified 7-day point prevalence abstinence from cigarette at 6 months. Secondary outcomes include: 1) 7-day point prevalence abstinence at 12 weeks and 1 year; 2) continuous abstinence at 12 weeks, 6 months, and 1 year; 3) change in the number of cigarettes smoked; 4) differences among groups in the effect of MI counseling based on participants' level of motivation; and, 5) differences among groups in the effect of the inhaler based on number of cigarettes smoked. This study will use a factorial design (2X2) in which 756 (189 in each arm) light smokers will be randomly assigned to one of four study arms: Tx1, Tx2, Tx3, and Tx4. Participants in Tx1 will receive placebo inhaler plus four health education sessions; Tx2 will receive placebo inhaler plus four MI counseling sessions; Tx3 will receive active nicotine inhaler plus four health education sessions; and, Tx4 will receive active nicotine inhaler plus four MI counseling sessions. Inhaler treatment (active or placebo) will be for 12 weeks. Recruitment and retention will be enhanced by use of monetary reimbursement for transportation and for completing study assessments, provision of attractive intervention materials, and a community advisory board. Post-intervention focus groups of quitters and non-quitters will assess the project's intervention components. Ultimately, we envision that the intervention, if efficacious, would enhance our understanding of smoking cessation and nicotine dependence, and could be used as a pre-packaged intervention for AA light smokers.

吸烟是所有美国人的疾病和死亡的主要预防原因。 非洲裔美国人（AAS）在城市贫困人口中的吸烟率仍然高达50％。 使他们能够戒烟是国家健康的重点。 在美国，戒烟工作主要集中在浓烟和排除的轻型吸烟者（每天烟雾S10香烟）上。 但是，多达50％的非裔美国人（AA）吸烟者是吸烟者。 尽管每天抽烟少，但AAS烟却吸烟的尼古丁含量更高，并且具有较高的烟草与烟草相关的发病率和死亡率。 使用尼古丁吸入器可能会帮助吸烟者戒烟；但是，尚未在轻度吸烟者中进行研究。 由于吸烟者构成了AA吸烟者的很大一部分，因此必须开发出包括药理学辅助工具和咨询策略在内的戒烟干预措施，以包括AA烟民。 这项研究的主要目的是评估尼古丁吸入器和动机采访在城市中吸烟者中戒烟的功效。这项随机的安慰剂对照研究将在密苏里州堪萨斯城的Swope Parkway Health Center的社区诊所进行。 该研究的主要结果是在6个月时对香烟的生化验证的7天点戒酒。 次要结果包括：1）12周零1年的7天点场禁欲； 2）在12周，6个月和1年时连续节制； 3）更改抽烟的香烟数量； 4）基于参与者的动机水平，小组之间的差异； 5）基于吸入的吸入数量的吸入剂的影响，群体之间的差异。这项研究将使用阶乘设计（2x2），其中756（每只手臂中的189个）将被随机分配到四个研究臂之一：TX1，TX2，TX3和TX4。 TX1的参与者将接受安慰剂吸入器加四个健康教育课程； TX2将接受安慰剂吸入器加四个MI咨询会议； TX3将获得活跃的尼古丁吸入器加四个健康教育课程；而且，TX4将获得活跃的Nicotine吸入器以及四个MI咨询会议。 吸入器治疗（活动或安慰剂）将持续12周。招聘和保留将通过使用货币报销进行运输和完成研究评估，提供有吸引力的干预材料以及社区顾问委员会的增强。 干预后的焦点群体和非疑问将评估项目的干预组成部分。 最终，我们设想，如果有效的话，这将增强我们对戒烟和尼古丁依赖性的理解，并可以用作对AA轻型吸烟者的预包装干预措施。