Supplemental Nicotine Administration for Smoking Cessation in PTSD

描述(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较低。有必要制定更有效的干预措施，并评估与创伤后应激障碍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是戒烟治疗中的一项创新发展，可能对治疗患有创伤后应激障碍的吸烟者特别有帮助。据预测，患有创伤后应激障碍的吸烟者在即兴吸烟期间补充尼古丁的使用将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个戒烟前贴片治疗条件中的1个(主动贴片与安慰剂贴片)，持续2周，然后目标戒烟日期。所有参与者都将接受短暂的认知行为疗法(CBT)，并在戒烟当天开始标准尼古丁替代疗法(NRT)。将使用电子日记评估仔细评估创伤后应激障碍症状、情绪、吸烟渴望和戒断症状。本研究的目的是：(1)通过电子日记评估来检验补充尼古丁对创伤后应激障碍症状、情绪、渴求和戒断的影响，(2)评估补充尼古丁对患有创伤后应激障碍的吸烟者戒烟率的影响，以及(3)调查包括创伤后应激障碍症状严重程度、基线情绪、焦虑敏感性、痛苦耐受性和自我效能在内的情感风格的个体差异。公共卫生相关性：这项研究可能有助于为患有创伤后应激障碍的吸烟者制定易于携带的戒烟策略，调查：1)补充尼古丁管理对渴望、情绪、创伤后应激障碍症状和戒断的影响；2)预治疗尼古丁贴片对戒烟率的可能益处；以及3)在这一高危人群中复发吸烟的危险因素。

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.