Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.
Contemp Clin Trials. 2012 Jan;33(1):197-205. doi: 10.1016/j.cct.2011.09.018. Epub 2011 Oct 8.
Cigarette smoking is prevalent in cocaine/methamphetamine-dependent patients and associated with significant morbidity and mortality, yet, the provision of smoking cessation treatment in conjunction with substance use disorder (SUD) treatment is not standard practice. This is due, in part, to clinician concern that combining smoking cessation treatment with SUD treatment could lead to poorer SUD outcomes. The NIDA Clinical Trials Network is conducting a 10-week, two-group, randomized trial to evaluate the impact of providing smoking cessation treatment (SCT) with SUD treatment as usual (TAU), compared to TAU alone, in smokers who are in outpatient treatment for cocaine or methamphetamine dependence. Approximately 528 participants, recruited from 12 community treatment programs, will be randomized into the trial. The present paper describes key design decisions made during protocol development. The trial is designed to evaluate the relationship between cigarette smoking and stimulant use, which prior research suggests is linked, and should contribute to our understanding of how best to address the co-occurring problems of nicotine dependence and cocaine/methamphetamine-dependence. Unique aspects of the trial include the primary question of interest, which concerns the impact of providing SCT on SUD outcomes rather than on smoking outcomes, and the intensity of the SCT chosen, which includes bupropion, nicotine replacement, and two psychosocial interventions.
吸烟在可卡因/冰毒依赖患者中很普遍，与显著的发病率和死亡率相关，然而，将戒烟治疗与物质使用障碍（SUD）治疗结合起来的做法并不常见。部分原因是临床医生担心将戒烟治疗与 SUD 治疗结合起来可能会导致 SUD 治疗结果更差。NIDA 临床试验网络正在进行一项为期 10 周、两组、随机试验，以评估在接受可卡因或甲基苯丙胺依赖门诊治疗的吸烟者中，与 SUD 治疗常规（TAU）相比，同时提供戒烟治疗（SCT）对 SUD 治疗结果的影响。大约 528 名参与者将从 12 个社区治疗项目中随机分组进入试验。本文描述了在方案制定过程中做出的关键设计决策。该试验旨在评估吸烟与兴奋剂使用之间的关系，先前的研究表明这两者之间存在关联，这应该有助于我们了解如何最好地解决尼古丁依赖和可卡因/冰毒依赖同时存在的问题。该试验的独特之处包括关注的主要问题，即提供 SCT 对 SUD 治疗结果的影响，而不是对吸烟结果的影响，以及选择的 SCT 强度，包括安非他酮、尼古丁替代和两种心理社会干预。
