INTENSIVE INTERVENTION FOR SMOKERS IN ALCOHOL TREATMENT

对于酒精依赖的吸烟者在早期恢复中的有效戒烟干预措施尚未确定，尽管这一人群的吸烟率很高，并且记录了戒烟的困难。 与强调尼古丁的复杂物质使用障碍患者的TRC主题一致，该TRC组成部分的主要目的是确定利用定制的扩展认知行为治疗（ECBT）和尼古丁替代疗法（CNRT）的强化戒烟干预的疗效和成本效益。为了实现这一目标，我们提出了一个双臂随机临床试验。在研究组1中，患者将接受ECBT和CNRT。CNRT将包括尼古丁透皮贴剂（TDN）和辅助尼古丁含片。ECBT是TRC合作者目前正在进行的戒烟研究中使用的基于手动的16次延长治疗的修改版本。在研究组2中，参与者将接受标准护理，包括转诊到独立的戒烟计划，该计划提供简短的咨询和TDN。我们将招募280名吸烟者，他们参加了圣弗朗西斯科退伍军人医疗中心（SFVAMC）和圣罗莎退伍军人社区门诊（CBOC）的药物和酒精治疗（DAT）项目。参加者必须戒酒至少一周，但不超过30天。我们将通过评估基线后3个月、6个月、9个月和12个月时经生物化学验证的点患病率吸烟状态以及12个月随访期间的持续戒烟来比较两个研究组的结局。呼出空气一氧化碳（CO）将用于生化验证7天时点戒烟率。我们还将进行经济分析，以确定与常规护理相比，强化干预的成本效益。我们还将在随访期间检查交叉复发模式，评估3、6、9和12个月时情绪状态和烟草、酒精和其他药物使用的变化。

Effective smoking cessation interventions have yet to be identified for alcohol-dependent smokers in early recovery, despite a high prevalence of smoking in this population, and documented difficulty in quitting. Congruent with the TRC theme of the complex substance use disorder patient with an emphasis on nicotine, the primary aim of this TRC component will be to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes tailored extended cognitive-behavioral therapy (ECBT) and combination nicotine replacement (CNRT). To accomplish this objective, we propose a two-arm randomized clinical trial. In Study Arm 1, patients will receive ECBT and CNRT. CNRT will consist of transdermal nicotine patches (TDN) and adjuvant nicotine lozenges. The ECBT is a modified version of a manual-based 16-session extended treatment currently used in ongoing smoking cessation studies by TRC collaborators. In Study Arm 2, participants will receive standard care that involves referral to a free-standing smoking cessation program that provides brief counseling and TDN. W e will recruit 280 smokers who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be eligible, participants must be abstinent from alcohol for at least one week, but not more than 30 days. We will compare outcomes for the two study arms by assessing biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon monoxide (CO) will be used to biochemically verify 7-day point prevalence abstinence. We will also conduct an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care. We will also examine cross-relapse pattems during the follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other drugs at 3, 6, 9, and 12 months.