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

对丙型肝炎和酒精滥用同时发生的患者进行综合治疗的随机对照试验

• 批准号: 9085181
• 负责人: Andrew J. Muir
• 金额: $ 69.03万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-05 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9085181
• 关键词: Abstinence; Address; Adult; Aftercare; Alcohol abuse; Alcohol consumption; Alcohol or Other Drugs use; Alcoholic beverage heavy drinker; Alcohols; Antiviral Agents; Antiviral Therapy; Behavior Therapy; Behavioral; Blood; Caring; Cirrhosis; Clinic; Collaborations; Comorbidity; Cost Effectiveness Analysis; Counseling; Development; Drug usage; Funding; Genotype; Health; Heavy Drinking; Hepatitis C; Hepatitis C virus; Hepatology; Individual; Infection; Institutes; Intervention; Interview; Lead; Literature; Liver; Liver Cirrhosis; Liver Fibrosis; Medical; Medical center; Mental Health; Mental disorders; Modeling; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Population; Preclinical Drug Evaluation; Primary carcinoma of the liver cells; Protease Inhibitor; Provider; Psychiatric therapeutic procedure; Qualifying; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recruitment Activity; Regimen; Relapse; Reporting; Ribavirin; Risk; Sample Size; Severities; Specialist; Testing; Time; Toxicology; United States; Urine; Veterans; Viral hepatitis; Virus; Visit; Woman; addiction; alcohol abstinence; alcohol abuse therapy; alcohol screening; alcohol testing; alcohol use disorder; arm; cost; cost effective; drinking; evidence base; falls; health economics; illicit drug use; improved; improved outcome; indexing; innovation; instrument; liver transplantation; medical specialist; medical specialties; meetings; men; mortality; multidisciplinary; next generation; primary care setting; response; secondary outcome; standard of care; therapy design; treatment as usual; trial comparing; trial design

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.

描述（由申请人提供）：对于感染丙型肝炎病毒（HCV）的人来说，饮酒会增加患肝细胞癌和进行性肝纤维化的风险，从而导致肝硬化和肝脏相关死亡。人们呼吁将酒精使用、物质使用和心理健康合并症的治疗结合起来的综合护理模型，但很少有经过实证检验的模型。 在一项 R21 研究中，我们为饮酒的 HCV 患者开发并实施了一种综合行为医学治疗模型。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；保留团体和个人治疗的参与者；成瘾专家和医疗服务提供者之间的综合护理；六个月的面试回复率为 85%。戒酒率从基线时的 0% 提高到 6 个月时的 44%。饮酒的平均成瘾严重程度指数得分从 0.24 降低到 0.12，降低了 50%，吸毒的平均成瘾严重程度指数得分从 0.05 降低到 0.03。重度饮酒者的比例从 47% 下降到 24%（Proeschold-Bell 等，2011）。 我们建议开展一项随机对照试验，对 230 名基线 AUDIT 酒精评分合格的 HCV 感染患者进行 6 个月的综合治疗与简短的酒精咨询进行比较。双臂的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 个月时进行评估。目的是 1) 评估戒酒情况； 2) 确定研究组间次要结果的差异； 3) 进行成本效益分析。我们假设与比较相比，干预措施将显着提高戒酒率并显着降低复发率。我们进一步假设，与对照参与者相比，干预参与者每周饮酒量更少，非法药物使用更少，阳性药物筛查更少，并达到健康经济学文献中规定的每个质量调整生命年 50,000 美元的标准。