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

描述（由申请人提供）：对于感染丙型肝炎病毒（HCV）的人，饮酒会增加肝细胞癌和进行性肝纤维化的风险，这可能导致肝硬化和肝脏相关死亡。已经呼吁将酒精使用，物质使用和精神健康合并症的治疗纳入护理的综合模式，但很少有经验验证的模式存在。 在一项R21研究中，我们为饮酒的HCV患者开发了一种综合行为医学治疗模式。我们使用酒精使用障碍识别测试（AUDIT）仪器在肝病诊所成功实施了标准化酒精筛查;招募了60名患者;保留了团体和个体治疗的参与者;成瘾专家和医疗提供者之间的综合护理;并实现了85%的六个月访谈应答率。戒酒率从基线时的0%提高到6个月时的44%。平均成瘾严重程度指数得分减少了50%，酒精从0.24到0.12，药物使用从0.05到0.03。重度饮酒者的百分比从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，在230名基线时具有合格AUDIT酒精评分的HCV感染患者中比较我们6个月的综合治疗与简短的酒精咨询。两组受试者将在杜克和杜克肝病诊所以及达勒姆退伍军人事务医疗中心接受治疗。将在基线、3、6和12个月时评估结局变量。其目的是：1）评估戒酒; 2）确定研究组之间次要结局的差异; 3）进行成本效益分析。我们假设，与对照组相比，干预措施将显著提高戒酒率，并显著降低复发率。我们进一步假设，干预参与者将报告每周较少的饮酒量和较少的非法药物使用比对照参与者，有较少的阳性药物筛选比对照参与者，并满足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.