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，PTSD患者成功戒烟的几率降低。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“治疗前”阶段使用补充尼古丁给药是戒烟治疗的最新创新发展，可能对治疗患有PTSD的吸烟者特别有帮助。在患有PTSD的吸烟者随意吸烟期间使用补充尼古丁给药预计可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在目标戒烟日期前被随机分配到2种戒烟前贴剂治疗条件中的1种（活性贴剂与安慰剂贴剂），持续2周。所有参与者将接受简短的认知行为治疗（CBT），并将在戒烟当天开始标准尼古丁替代治疗（NRT）。将使用电子日记评估仔细评估PTSD症状、情绪、吸烟渴望和戒断症状。这项研究旨在实现以下目标：（1）通过电子日记评估来检查补充尼古丁给药对PTSD症状、情绪、渴望和戒断的影响，（2）评估补充尼古丁给药对患有PTSD的吸烟者的戒烟率的影响，（3）探讨复发的潜在预测因素，包括情感风格的个体差异，包括PTSD症状严重程度，基线情绪，焦虑敏感性，痛苦承受力和自我效能的测量。公共卫生相关性：本研究可通过调查以下内容为患有PTSD的吸烟者提供易于携带的戒烟策略的开发信息：1）补充尼古丁给药对渴望、情绪、PTSD症状和戒断的影响; 2）尼古丁贴片预治疗对戒烟率的可能获益; 3）该风险人群中吸烟复发的风险因素。

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.