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

伐尼克兰治疗艾滋病毒/艾滋病患者吸烟的安慰剂对照试验

基本信息

批准号：
9084516
负责人：
Robert A Schnoll
金额：
$ 49.99万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-06-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9084516
关键词：
AIDS/HIV problem Abstinence Acquired Immunodeficiency Syndrome Address Adverse effects Affect Agonist Anti-Retroviral Agents Area Behavior Therapy Bupropion Cardiovascular Diseases Cause of Death Cessation Research Cholesterol Clinical Trials Communities Comorbidity Controlled Clinical Trials Controlled Study Counseling Data Diagnosis Disease Evaluation FDA approved Frequencies Gender General Population Guidelines HIV Health Highly Active Antiretroviral Therapy Immunologics Impaired cognition Individual Kaposi Sarcoma Literature Malignant neoplasm of lung Mediating Mediator of activation protein Medical Mental Depression Methods Morbidity - disease rate Nicotine Dependence Nicotinic Receptors Non-Hodgkin&apos s Lymphoma Participant Patients Pharmaceutical Preparations Placebo Control Placebos Population Prevalence Quality of life Race Randomized Recommendation Research Personnel Risk Risk Factors Safety Sampling Smoke Smoker Smoking Socioeconomic Status Substance abuse problem Survival Rate Symptoms Time Tobacco Tobacco use Triglycerides United States Public Health Service Viral Withholding Treatment Work arm base cardiovascular risk factor clinical care cognitive performance depressive symptoms design experience group counseling high risk improved innovation modifiable risk mortality negative affect nicotine patch open label outcome forecast placebo controlled study psychological distress response smoking cessation smoking relapse tobacco control transmission process treatment response varenicline

项目摘要

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.

描述（由申请人提供）：在过去的几十年中，艾滋病毒/艾滋病的医疗方面取得了重大进展，使解决烟草在该人群中使用了关键的健康问题。不幸的是，有50-74％的艾滋病毒/艾滋病患者是常规吸烟者，这些吸烟者降低了对抗返回病毒药物（HAART）的病毒和免疫学反应（HAART），增加了HAART加剧心血管危险因素，并恶化HIV症状和生活质量的生活质量（QOL）。迄今为止，烟草控制研究人员严重研究了这组吸烟者。患有艾滋病毒/艾滋病的个体因其诊断或由于同时发生的医学和精神病疾病而被排除在尼古丁依赖药物的大型临床试验之外，这些病例可以影响对尼古丁依赖性治疗的反应，并且仅与HIV/AIDS一起进行了三项戒烟临床试验。因此，有关戒烟治疗的当前文献可能不会推广到患有艾滋病毒/艾滋病的吸烟者的人群，包括用于治疗烟碱依赖性的药物的疗效和安全性，并且经验数据很少，并且在HIV/艾滋病患者中，基于nicotine依赖性的经验数据。这导致美国公共卫生服务呼吁对烟碱依赖性治疗的系统评估，以此作为关键的优先事项。本研究将代表艾滋病毒/艾滋病吸烟者中尼古丁依赖性的第一个随机安慰剂对照临床试验。 Varenicline是吸烟者普通人群中尼古丁依赖性最有效的药物，对于患有艾滋病毒/艾滋病的吸烟者来说可能特别有效，因为这些吸烟者经历了高水平的心理困扰和认知障碍，可以通过varenicline来缓解。该试验有能力充分评估疗效和安全性，并可能有助于填补尼古丁依赖文献的重要差距，以及依赖于指导艾滋病毒/艾滋病患者的临床护理的文献。通过诊断为HIV/AIDS的310名吸烟者的样本，我们将解决以下目的：1）将12周的Varenicline治疗和行为咨询比较与安慰剂治疗的12周和行为咨询，以治疗HIV/AIDS中尼古丁依赖性的行为咨询〜2）评估对QOL和VARENICLINE效果的效果和3）的效果，并评估副作用的效果和3）。治疗对退出率的影响。我们还将探索与参与者相关的变量，作为Varenicline治疗对戒烟率的影响的主持人。总体而言，我们预计这项研究将提供必要的数据，以指导使用艾滋病毒/艾滋病患者的尼古丁依赖性的使用，从而有可能提供有效的策略，以减少这个服务不足的吸烟者社区中与烟草相关的发病率和死亡率。