Nahvi Shadi, Segal Kate S, Litwin Alain H, Arnsten Julia H
Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, 10467 Bronx, NY, USA.
Addict Sci Clin Pract. 2014 Jun 13;9(1):9. doi: 10.1186/1940-0640-9-9.
Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment.
METHODS/DESIGN: We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models.
This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment.
clinicaltrials.gov NCT01378858.
戒烟药物依从性是少数几个被证明能提高美沙酮维持治疗吸烟者戒烟率的因素之一，但改善戒烟药物依从性的干预措施尚未在美沙酮治疗患者中进行测试。基于美沙酮诊所的针对艾滋病毒和结核病的直接观察治疗（DOT）项目可提高依从性和临床疗效，但尚未对其戒烟效果进行评估。我们描述了一项随机对照试验，以评估基于美沙酮诊所的直接观察伐尼克兰治疗项目是否能提高接受美沙酮治疗的阿片类药物依赖吸毒者的依从性和戒烟率。
方法/设计：我们计划招募100名接受美沙酮维持治疗的吸烟者，并将他们随机分为两组，一组接受与每日美沙酮剂量一起发放的直接观察伐尼克兰治疗，另一组接受常规治疗（自行服用伐尼克兰），为期12周。我们的结局指标是：1）药丸计数依从性和2）经一氧化碳验证的戒烟情况。我们将使用重复测量模型评估两个治疗组在依从性和戒烟方面的差异。
这项试验将严格评估基于美沙酮诊所的直接观察伐尼克兰治疗在改善依从性和戒烟结局方面的疗效。对试验方法的详细描述可作为未来DOT项目开发的模板，并可为接受美沙酮治疗的阿片类药物依赖吸烟者的研究方案提供指导。
clinicaltrials.gov NCT01378858。
