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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(申请人提供)：在过去几十年中，艾滋病毒/艾滋病的医疗治疗取得了重大进展，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/艾滋病患者是经常吸烟的人，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而加剧的心血管危险因素，并恶化了HIV症状和生活质量(QOL)。到目前为止，烟草控制研究人员对这一吸烟者亚群进行了严格的研究。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可能影响尼古丁依赖治疗反应的共同出现的医疗和精神疾病，只对艾滋病毒/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不适用于患有艾滋病毒/艾滋病的吸烟者，包括用于治疗尼古丁依赖的药物的有效性和安全性，而且缺乏经验数据来作为治疗艾滋病毒/艾滋病患者尼古丁依赖的建议的基础。这导致美国公共卫生服务呼吁对这一吸烟者亚群体的尼古丁依赖治疗进行系统评估，作为关键优先事项。这项研究将是首次随机、安慰剂对照的临床试验，即在患有HIV/AIDS的吸烟者中使用varenicline治疗尼古丁依赖。在普通吸烟者中，varenicline是治疗尼古丁依赖的最有效药物，对患有艾滋病毒/艾滋病的吸烟者可能特别有效，因为这些吸烟者经历了高度的心理痛苦和认知障碍，而varenicline可以减轻这些痛苦。这项试验旨在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以及指导艾滋病毒/艾滋病患者临床护理的文献中的一个关键空白。通过对310名被诊断为HIV/AIDS的吸烟者的样本，我们将解决以下目标：1)比较12周的varenicline治疗和行为咨询与12周的安慰剂治疗和行为咨询治疗HIV/AIDS患者的尼古丁依赖~2)评估varenicline治疗对生活质量和varenicline相关副作用的影响，3)评估情感和认知表现的变化作为varenicline治疗对戒烟率影响的中介。我们还将探索参与者相关变量作为伐伦克林治疗对戒毒率影响的调节因素。总体而言，我们预计这项研究将提供必要的数据，以指导在艾滋病毒/艾滋病患者中使用varenicline治疗尼古丁依赖，从而可能提供一种有效的战略，在这一服务不足的吸烟者群体中减少与烟草有关的发病率和死亡率。