R01-Williajm - Double-Blind Placebo-Controlled trial of Nicotine Nasal Spray as a

R01-Williajm - 尼古丁鼻喷雾剂的双盲安慰剂对照试验

基本信息

批准号：
7903369
负责人：
JILL M WILLIAMS
金额：
$ 39万
依托单位：
UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-01 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7903369
关键词：
Abstinence Acute Address Adverse effects Adverse event Applications Grants Behavior Therapy Blood Bupropion Carbon Monoxide Case Series Characteristics Cigarette Clinical Clinical Trials Control Groups Cues Dependence Devices Disease Dopamine Dose Exhalation General Population Hour Human Individual Laboratories Measures Mental disorders Nicotine Nicotine Dependence Nicotine Nasal Spray Nicotine Withdrawal Nicotinic Receptors Nose Outcome Patient Self-Report Pharmaceutical Preparations Physiological Placebos Property Publishing Randomized Recommendation Refractory Relapse Reporting Research Research Support Saccades Safety Schizoaffective Disorders Schizophrenia Serum Severities Smoke Smoker Smoking Specialized Center Speed Structure of mucous membrane of nose Symptoms Testing Time Tobacco Tobacco smoke Tobacco use Withdrawal Withdrawal Symptom craving double-blind placebo controlled trial drug craving early experience experience hazard mesolimbic system neurotransmission nicotine patch nicotine replacement open label placebo controlled study public health relevance research study response sensory gating smoking cessation smoking prevalence therapy design time use tobacco abstinence years of life lost

项目摘要

DESCRIPTION (provided by applicant): Smokers with schizophrenia have been under-studied yet smoke at increased rates and suffer disproportionate tobacco-caused disease. To date there have been no placebo controlled trials of Nicotine Replacement Therapy (NRT) in schizophrenia and open label nicotine patch studies have yielded quit rates of about half that seen in other smokers. Our studies showing higher serum nicotine levels in schizophrenia (Williams et al., 2005) indicate a need for nicotine delivery treatment that more closely resembles smoking. Nicotine Nasal Spray (NNS) differs from other forms of NRT in that nicotine is absorbed rapidly through the nasal mucosa and produces physiological effects that are expected to speed relief of withdrawal and craving. Our clinical experience and human laboratory experiments indicate good tolerability and utilization of NNS as well as reduced craving in subjects with schizophrenia. This R01 grant application describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray as an aid for smoking cessation in 120 individuals with schizophrenia. The primary aims of this study are to: 1) Determine if nicotine nasal spray is more effective than placebo nasal spray as an aid for smoking cessation in individuals with schizophrenia, 2) Determine if nicotine nasal spray reduces the severity of symptoms of nicotine withdrawal and urges to smoke as compared to placebo nasal spray in smokers with schizophrenia. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the Target Quit Date (TQD) and through the end of Week 20. Quit rate will be defined as the proportion of individuals who self report tobacco abstinence during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm). Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 sessions over 26 weeks. Secondary objectives are to: 1) Determine if nicotine nasal spray is more effective than placebo nasal spray as an aid for smoking cessation in individuals with schizophrenia at Study Weeks 12, 20, 26 and 52, 2) Determining if initial positive effects from first time use of the NNS as measured by the Initial Spray Experience (ISE) scale predict subsequent use of NNS and cessation in smokers with schizophrenia, and 3)Determine the safety of NNS versus placebo NS for smoking cessation in smokers with schizophrenia as assessed by adverse events and vital signs. PUBLIC HEALTH RELEVANCE: People with schizophrenia are nearly three times as likely to smoke as the general population, with heavy smoking occurring commonly. Smoking caused diseases are also common in individuals with schizophrenia, with recent estimates of 25 years of life lost, much of which is attributable to smoking. Smokers with schizophrenia are approximately half as likely to quit smoking as smokers without a major mental illness for reasons that are still poorly understood. There is a need to systematically examine available treatments and explore new ones that can address their needs.

描述（由申请人提供）：精神分裂症的吸烟者被研究不足，但以增加的速度吸烟，并遭受了不成比例的烟草引起的疾病。迄今为止，精神分裂症和开放式标签尼古丁斑块研究中尚无安慰剂对照试验（NRT）的戒烟率约为其他吸烟者的一半。我们的研究表明，精神分裂症中较高的血清尼古丁水平（Williams等，2005）表明需要对尼古丁递送治疗，这更像吸烟。尼古丁鼻喷雾剂（NNS）与其他形式的NRT不同，因为尼古丁通过鼻粘膜迅速吸收，并产生的生理作用预计会加快戒断和渴望的缓解。我们的临床经验和人类实验室实验表明，NNS的耐受性和利用良好，并减少了精神分裂症受试者的渴望。此R01赠款应用描述了尼古丁鼻喷雾剂的随机，双盲，安慰剂对照试验，以帮助120名精神分裂症患者的戒烟。这项研究的主要目的是：1）确定尼古丁鼻喷雾是否比安慰剂鼻喷雾更有效，以帮助戒烟，以便在精神分裂症患者中进行戒烟，2）确定尼古丁鼻鼻喷雾是否会减少尼古丁戒断症状的严重程度，并与吸烟中的鼻虫喷雾相比吸烟与schizophrenia相比吸烟。 Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the Target Quit Date (TQD) and through the end of Week 20. Quit rate will be defined as the proportion of individuals who self report tobacco abstinence during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm).两组将接受针对精神分裂症设计的行为干预，在26周内以15个疗程进行。 Secondary objectives are to: 1) Determine if nicotine nasal spray is more effective than placebo nasal spray as an aid for smoking cessation in individuals with schizophrenia at Study Weeks 12, 20, 26 and 52, 2) Determining if initial positive effects from first time use of the NNS as measured by the Initial Spray Experience (ISE) scale predict subsequent use of NNS and cessation in smokers with schizophrenia, and 3)Determine the safety of通过不良事件和生命体征评估的精神分裂症吸烟者的NNS与安慰剂NS。公共卫生相关性：精神分裂症患者吸烟的可能性几乎是普通人群的三倍，通常会发生大量吸烟。在精神分裂症患者中，吸烟引起的疾病也很常见，最近估计有25年的生命丧失，其中大部分归因于吸烟。患有精神分裂症的吸烟者大约有一半的可能是吸烟者，而没有重大精神疾病的吸烟者，原因尚不清楚。有必要系统地检查可用的治疗方法，并探索可以满足其需求的新治疗方法。