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

描述（由申请人提供）：对于丙型肝炎病毒（HCV）感染者，酒精使用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。人们呼吁综合治疗酒精使用、物质使用和精神健康合并症的护理模式，但很少有经过经验检验的模式存在。在一项R21研究中，我们为饮酒的丙型肝炎患者开发并规范化了一种综合行为-医学治疗模式。我们成功地在肝病诊所使用酒精使用障碍鉴定测试（AUDIT）工具实施了标准化的酒精筛查；招募患者60例；保留小组和个人治疗的参与者；戒毒专家和医疗提供者之间的综合护理；达到了85%的六个月面试回复率。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分数降低了50%24到。12岁，吸毒人数从。05到0.03。重度饮酒者的比例从47%下降到24% （Proeschold-Bell et al., 2011）。我们建议进行一项随机对照试验，对230例基线酒精评分符合审计标准的hcv感染患者进行为期6个月的综合治疗与简短的酒精咨询进行比较。两组参与者将在杜克大学和北卡罗来纳大学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、6和12个月进行评估。目的是1)评估戒酒情况；2)确定各组间次要结局的差异；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报告的每周饮酒和非法药物使用比对照组参与者少，阳性药物筛查比对照组参与者少，并且达到卫生经济学文献中建立的每个质量调整生命年获得的50,000美元标准。

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.