RCT of an Integrated Treatment of Persons with Co-Occurring HCV and Alcohol Abuse

描述(申请人提供)：对于感染丙型肝炎病毒(丙型肝炎病毒)的人，饮酒会增加患肝细胞癌和进行性肝纤维化的风险，这可能会导致肝硬化和与肝脏相关的死亡。整合了酒精使用、物质使用和精神健康并存治疗的综合护理模式已经被呼吁，但很少有经验证的模式存在。在R21研究中，我们为饮酒的丙型肝炎患者开发和手册了一个整合的行为-医学治疗模型。我们成功地使用酒精使用障碍识别测试(AUDIT)工具在一家肝病诊所实施了标准化的酒精筛查；招募了60名患者；保留了小组和个人治疗的参与者；成瘾专家和医疗提供者之间的综合护理；并实现了85%的六个月访谈回复率。戒酒率从基线的0%提高到6个月时的44%。酒精的平均成瘾严重指数得分从0.24下降到0.12，吸毒的平均成瘾严重指数得分从0.05下降到0.03。酗酒者的比例从47%下降到24%(Proeschold-Bell等人，2011年)。我们建议进行一项随机对照试验，比较我们六个月的综合治疗和简单的酒精咨询在230名丙型肝炎病毒感染患者中的基线合格审核酒精评分。双方的参与者都将在杜克大学和北卡罗来纳大学的肝脏诊所以及达勒姆退伍军人事务医疗中心接受治疗。结果变量将在基线、3个月、6个月和12个月进行评估。其目的是1)评估戒酒；2)确定研究小组之间二次结果的差异；以及3)进行成本效益分析。我们假设，与对照相比，干预将显著提高戒酒率，显著降低复发率。我们进一步假设，与对照参与者相比，干预参与者报告的每周饮酒量和非法药物使用将更少，阳性药物筛查比对照参与者更少，并达到卫生经济学文献中建立的每质量调整生命年获得50,000美元的标准。

DESCRIPTION (provided by applicant): For people infected with hepatitis C virus (HCV), alcohol use increases the risk of hepatocellular carcinoma and progressive liver fibrosis, which can lead to cirrhosis and liver-related mortality. Integrated models of care that incorporate treatment for alcohol use, substance use, and mental health comorbidities have been called for, but few empirically tested models exist. In an R21 study, we developed and manualized an integrated behavioral-medical treatment model for patients with HCV who consume alcohol. We successfully implemented a standardized alcohol screening in a hepatology clinic using the Alcohol Use Disorders Identification Test (AUDIT) instrument; recruited 60 patients; retained participants in group and individual therapy; integrated care between an addictions specialist and medical providers; and achieved an 85% six-month interview response rate. The alcohol abstinence rate improved from 0% at baseline to 44% at 6 months. Mean Addiction Severity Index scores were reduced by 50% for alcohol from .24 to .12, and decreased for drug use from .05 to .03. The percentage of heavy drinkers decreased from 47% to 24% (Proeschold-Bell et al., 2011). We propose conducting a randomized controlled trial that compares our six-month integrated treatment versus brief alcohol counseling in 230 HCV-infected patients with qualifying AUDIT alcohol scores at baseline. Participants in both arms will be treated at the Duke and UNC Liver Clinics and the Durham Veterans Affairs Medical Center. Outcome variables will be assessed at baseline, 3, 6, and 12 months. The aims are to 1) evaluate alcohol abstinence; 2) determine differences in secondary outcomes between study arms; and 3) conduct a cost effectiveness analysis. We hypothesize that the intervention will significantly improve alcohol abstinence rates and significantly decrease relapse rates compared to the comparison. We further hypothesize that intervention participants will report fewer drinks per week and less illict drug use than comparison participants, have fewer positive drug screens than comparison participants, and meet the $50,000 per quality-adjusted life year gained standard established in the health economics literature.