A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

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• 作者：Sophia I. Allen ; Jonathan Foulds ; Gladys N. Pachas ; Susan Veldheer…
• 关键词：Tobacco ; Cigarettes ; RCT ; Mood ; Anxiety ; Spectrum ; Cotinine ; NNAL
• 刊名：BMC Public Health
• 出版年：2017
• 出版时间：December 2017
• 年：2017
• 卷：17
• 期：1
• 全文大小：752KB
• 刊物主题：Public Health; Medicine/Public Health, general; Epidemiology; Environmental Health; Biostatistics; Vaccine;
• 出版者：BioMed Central
• ISSN：1471-2458
• 卷排序：17

文摘

BackgroundThe U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks.