A Placebo Controlled Trial of Varenicline for Smoking among those with HIV/AIDS

描述（由申请人提供）：过去几十年来，在艾滋病毒/艾滋病的医疗方面取得了重大进展，这使得解决烟草使用问题成为这一人群中的一个关键健康问题。不幸的是，50-74%的艾滋病毒/艾滋病患者经常吸烟，这降低了对抗逆转录病毒药物（HAART）的病毒和免疫反应，增加了因HAART而加剧的心血管风险因素，并使艾滋病毒症状和生活质量（QOL）恶化。迄今为止，烟草控制研究人员对这一烟民亚群的研究还非常不足。艾滋病毒/艾滋病患者被排除在尼古丁依赖药物的大型临床试验之外，因为他们的诊断或因为同时发生的医学和精神状况可能影响对尼古丁依赖治疗的反应，并且仅对艾滋病毒/艾滋病患者进行了三次戒烟临床试验。因此，目前关于戒烟治疗的文献可能无法推广到患有艾滋病毒/艾滋病的吸烟者群体，包括用于治疗尼古丁依赖的药物的有效性和安全性，并且缺乏经验数据来为治疗艾滋病毒/艾滋病患者的尼古丁依赖提供建议。这使得美国公共卫生服务部门呼吁对这一吸烟者亚群的尼古丁依赖治疗进行系统评估，并将其作为关键优先事项。本研究将是首个随机安慰剂对照临床试验，使用伐尼克兰治疗艾滋病毒/艾滋病吸烟者的尼古丁依赖。伐尼克兰是一般吸烟者中治疗尼古丁依赖最有效的药物，可能对患有艾滋病毒/艾滋病的吸烟者特别有效，因为这些吸烟者会经历高度的心理困扰和认知障碍，而伐尼克兰可以减轻这些问题。该试验能够充分评估其有效性和安全性，可能有助于填补尼古丁依赖文献以及指导艾滋病毒/艾滋病患者临床护理的文献的关键空白。以310名被诊断为HIV/AIDS的吸烟者为样本，我们将探讨以下目的：1)比较12周的伐尼克兰治疗和行为咨询与12周的安慰剂治疗和行为咨询对治疗HIV/AIDS患者尼古丁依赖的影响；2)评估伐尼克兰治疗对生活质量的影响和与伐尼克兰相关的副作用；3)评估影响伐尼克兰治疗对戒烟率影响的情绪和认知表现的变化。我们还将探讨参与者相关变量作为伐尼克兰治疗对戒烟率影响的调节因子。总的来说，我们期望这项研究将提供必要的数据来指导使用varenicline治疗艾滋病毒/艾滋病患者的尼古丁依赖，从而有可能为减少这一服务不足的吸烟者社区的烟草相关发病率和死亡率提供有效的策略。

DESCRIPTION (provided by applicant): The significant progress made over the past several decades in the medical treatment of HIV/AIDS has made addressing tobacco use a critical health issue in this population. Unfortunately, 50-74% of individuals with HIV/AIDS are regular smokers which reduce viral and immunologic response to anti-retroviral medications (HAART), increases cardiovascular risk factors exacerbated by HAART, and worsens HIV symptoms and quality of life (QOL). To date, this sub-group of smokers has been critically under-studied by tobacco control researchers. Individuals with HIV/AIDS have been excluded from large clinical trials of nicotine dependence medications because of their diagnosis or because of co-occurring medical and psychiatric conditions which can affect response to treatments for nicotine dependence and only three smoking cessation clinical trials have been conducted with those with HIV/AIDS. As such, the current literature on smoking cessation treatments may not generalize to the population of smokers with HIV/AIDS, including both the efficacy and the safety of medications for use to treat nicotine dependence, and there is a paucity of empirical data on which to base recommendations for the treatment of nicotine dependence among those with HIV/AIDS. This has led the US Public Health Service to call for the systematic evaluation of nicotine dependence treatments for this sub-group of smokers as a critical priority. The present study will represent the first randomized placebo-controlled clinical trial of varenicline for nicotine dependence among smokers with HIV/AIDS. Varenicline is the most efficacious medication for nicotine dependence in the general population of smokers and may be particularly efficacious for smokers with HIV/AIDS since these smokers experience high levels of psychological distress and cognitive impairment which can be mitigated by varenicline. This trial is powered to adequately evaluate efficacy and safety, and may help fill a critical gap in th nicotine dependence literature as well as the literature relied upon to guide the clinical care of patients with HIV/AIDS. With a sample of 310 smokers diagnosed with HIV/AIDS we will address the following aims: 1) Compare 12-weeks of varenicline treatment and behavioral counseling to 12-weeks of placebo treatment and behavioral counseling for treating nicotine dependence among individuals with HIV/AIDS~ 2) Assess effects of varenicline therapy on QOL and varenicline associated side effects~ and 3) Assess changes in affect and cognitive performance as mediators of varenicline therapy's effect on quit rates. We will also explore participant-related variables as moderators of varenicline therapy's effect on quit rates. Overall we expect that this study will provide the data necessary to guide the use of varenicline for the treatment of nicotine dependence among those with HIV/AIDS, thereby potentially offering an efficacious strategy to reduce tobacco-related morbidity and mortality in this under-served community of smokers.