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

• 批准号: 8470613
• 负责人: Robert A Schnoll
• 金额: $ 47.59万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8470613
• 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; Cognitive; 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' s Lymphoma; Participant; Patients; Performance; 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; depressive symptoms; design; experience; group counseling; high risk; improved; innovation; modifiable risk; mortality; nicotine patch; open label; outcome forecast; placebo controlled study; psychological distress; response; smoking cessation; smoking relapse; tobacco control; transmission process; treatment response; varenicline

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）：过去几十年来，在艾滋病毒/艾滋病的医学治疗方面取得了重大进展，这使得解决烟草使用问题成为该人群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者，这降低了抗逆转录病毒药物（HAART）的病毒和免疫反应，增加了HAART加剧的心血管风险因素，并降低了艾滋病毒症状和生活质量（QOL）。迄今为止，烟草控制研究人员对这一吸烟者亚组的研究严重不足。艾滋病毒/艾滋病患者因其诊断或同时发生的医学和精神疾病而被排除在尼古丁依赖药物的大型临床试验之外，这些疾病可能影响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项戒烟临床试验。因此，目前关于戒烟治疗的文献可能无法推广到艾滋病毒/艾滋病吸烟者人群，包括用于治疗尼古丁依赖的药物的疗效和安全性，并且缺乏经验数据，可作为艾滋病毒/艾滋病患者尼古丁依赖治疗建议的基础。这导致美国公共卫生署呼吁将系统评估这一吸烟者亚组的尼古丁依赖治疗作为一个关键优先事项。本研究将代表第一个随机安慰剂对照的临床试验伐尼克兰尼古丁依赖的吸烟者与艾滋病毒/艾滋病。伐尼克兰是一般吸烟人群中尼古丁依赖的最有效药物，对HIV/AIDS吸烟者可能特别有效，因为这些吸烟者会经历高水平的心理困扰和认知障碍，而伐尼克兰可以缓解这些症状。本试验有充分的把握度来评估疗效和安全性，并可能有助于填补尼古丁依赖文献以及指导HIV/AIDS患者临床护理所依赖的文献中的关键空白。通过对310名被诊断患有艾滋病毒/艾滋病的吸烟者进行抽样调查，我们将实现以下目标：1）比较12周伐尼克兰治疗和行为咨询与12周安慰剂治疗和行为咨询治疗HIV/AIDS患者尼古丁依赖的效果~ 2）评估伐尼克兰治疗对QOL和伐尼克兰相关副作用的影响~和3）评估作为伐尼克兰治疗对戒烟率影响的介质的情感和认知表现的变化。 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，我们希望这项研究将提供必要的数据，指导使用伐尼克兰治疗艾滋病毒/艾滋病患者的尼古丁依赖，从而可能提供一种有效的策略，以减少烟草相关的发病率和死亡率在这个服务不足的吸烟者社区。