Supplemental Nicotine Administration for Smoking Cessation in PTSD

描述（由申请人提供）：吸烟在创伤后应激障碍（PTSD）患者中非常普遍，而PTSD患者成功戒烟的几率较低。有必要制定更有效的干预措施，并评估与PTSD患者戒烟相关的因素。在目标戒烟日期之前的“前治疗”阶段使用补充尼古丁管理是戒烟治疗中最近的一项创新发展，可能对治疗患有PTSD的吸烟者特别有帮助。对于患有PTSD的吸烟者，在即兴吸烟期间使用补充尼古丁可以减少对吸入尼古丁的生理和情感依赖，从而增加成功戒烟的几率。患有创伤后应激障碍的吸烟者将被随机分配到2种戒烟前贴片治疗条件中的1种（活性贴片与安慰剂贴片），在目标戒烟日期前2周。所有参与者将接受简短的认知行为疗法（CBT），并在戒烟当天开始标准的尼古丁替代疗法（NRT）。创伤后应激障碍症状，情绪，吸烟渴望和戒断症状将使用电子日记评估仔细评估。这项研究旨在达到以下目的：(1)通过电子日记评估尼古丁补充给药对PTSD症状、情绪、渴望和戒断的影响；(2)评估尼古丁补充给药对PTSD吸烟者戒烟率的影响；(3)研究复发的潜在预测因素，包括PTSD症状严重程度、基线情绪、焦虑敏感性、痛苦耐受性测量和自我效能感等情感类型的个体差异。公共卫生相关性：本研究通过调查：1)补充尼古丁给药对渴望、情绪、PTSD症状和戒断的影响；2)尼古丁贴片预处理对戒断率的可能益处；3)高危人群吸烟复吸的危险因素。

DESCRIPTION (provided by applicant): Cigarette smoking is highly prevalent among persons with posttraumatic stress disorder (PTSD) and individuals with PTSD have decreased odds of successfully quitting smoking. There is a need to develop more effective interventions and to evaluate factors associated with smoking abstinence in persons with PTSD. The use of supplemental nicotine administration during a "pre-treatment" phase before a targeted quit date is a recent innovative development in smoking cessation therapy and may be particularly helpful in treating smokers with PTSD. The use of supplemental nicotine administration during ad lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation. Smokers with PTSD will be randomly assigned to 1 of 2 pre- cessation patch therapy conditions (active patch versus placebo patch) for 2 weeks before a target quit- smoking date. All participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, smoking craving and withdrawal symptoms will be carefully evaluated using electronic diary assessment. The study is designed to address the following aims: (1) To examine the effects of supplemental nicotine administration on PTSD symptoms, mood, craving, and withdrawal through electronic diary assessment, (2) To evaluate the effect of supplemental nicotine administration on quit rates among smokers with PTSD, and (3) To investigate potential predictors of relapse including individual differences in affective style including PTSD symptom severity, baseline mood, anxiety sensitivity, measures of distress tolerance, and self-efficacy. PUBLIC HEALTH RELEVANCE: This study may serve to inform development of easily portable smoking cessation strategies for smokers with PTSD by investigating: 1) the effects of supplemental nicotine administration on craving, mood, PTSD symptoms, and withdrawal; 2) the possible benefit of pre-treatment with nicotine patches on abstinence rates; and 3) risk- factors for smoking relapse in this at risk population.