Preloading with Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts

摘要 在美国，吸烟在艾滋病毒感染者（PWH）中比一般人更普遍。 这与这一人群发病率和死亡率的增加有关。此外，艾滋病毒阳性 吸烟者患肺癌和其他与吸烟有关的癌症的比率增加。携带艾滋病病毒的吸烟者尤其 挑战组，经常报告尼古丁依赖的严重程度高，自我效能低， 戒烟，这两个因素都与戒烟效果不佳有关。建立更有效的吸烟 艾滋病毒感染者的戒烟方法，特别是那些解决自我效能低和严重 依赖性是公共卫生的优先事项。本研究项目的总体目标是检查可行性， 尼古丁替代疗法预负荷（NRT-P）在HIV阳性患者中的可接受性和初步疗效 吸烟者，谁是香烟依赖斗争，敦促吸烟（渴望）和低自我效能， 成功戒烟的障碍。将招募60名受试者进入为期12周的随机试验 study. 30名参与者（对照条件）将接受标准戒烟咨询（NRT-S）， 将在戒烟日（第4周）开始一个8周的尼古丁贴片和锭剂联合治疗疗程， 根据吸烟率推荐的指南。30名受试者（活动状态）将开始NRT贴片3 戒烟日期前10周，随后接受8周尼古丁贴片和锭剂联合治疗，开始时间为 退出日期。我们将检查戒烟前后的依赖性、吸烟冲动和戒烟自我效能 约会我们还将研究戒烟尝试和生物化学验证戒烟的差异 在第8周和第12周，对照和活性条件之间。这项研究将是第一次审查 使用NRT预加载的新型干预措施的可行性和初步疗效， 威尔斯亲王医院的戒烟结果。鉴于吸烟率高， 研究威尔斯亲王医院的相关发病率，制定有效的策略，以减低 吸烟在这个群体中是至关重要的。如果确定这种干预措施有效， 在艾滋病诊所传播。我们的研究将提供关于以下潜在益处的关键信息： 在高度依赖尼古丁且极易受尼古丁影响的人群中进行NRT预加载 与吸烟有关的发病率和死亡率。该项目的结果将为 未来R 01申请国家癌症研究所进行全面的随机临床试验。

ABSTRACT Cigarette smoking is more prevalent in persons with HIV (PWH) in the U.S. when compared with the general population and is linked to increased morbidity and mortality in this population. Furthermore, HIV-positive smokers have increased rates of lung and other smoking-related cancers. Smokers with HIV are a particularly challenging group, often reporting high severity of nicotine dependence and low rates of self-efficacy for quitting, both factors related to poor smoking cessation outcomes. Establishing more effective smoking cessation approaches for smokers with HIV, particularly those that address low self-efficacy and severe dependence, is a public health priority. The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 12-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge on quit date (week 4), consistent with recommended guideline based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge, initiated on quit date. We will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. We will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8 and 12. This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes in PWH. Given the high prevalence of smoking and the significant morbidity associated with it in PWH, the development of effective strategies to reduce the risks related to smoking in this group is critical. If determined to be effective, this intervention could be readily disseminated in HIV clinics. Our study will provide key information on the potential benefit of NRT preloading in a population that is highly dependent on nicotine and highly vulnerable to smoking-related morbidity and mortality. The results from this project will provide the foundation for a future R01 application to the National Cancer Institute to conduct a full-scale randomized clinical trial.