Novel EtG based Contingency Management for Alcohol in the Severely Mentally Ill

描述（申请人提供）：基于乙基葡萄糖醛酸苷（EtG）的新型酒精应急管理在严重精神病患者中的应用我们建议进行一项随机临床试验，研究12周的基于乙基葡萄糖醛酸苷（EtG）尿液分析的应急管理（CM）干预对酒精依赖（AD）和严重精神病（SMI）患者减少酒精使用和增加酒精治疗出勤率的影响，这些患者接受长期治疗，社区心理健康治疗。虽然CM是一种针对非法药物使用的循证治疗方法，但由于缺乏实用的酒精生物标志物作为CM范式的基础，因此有关其对AD疗效的研究有限。这项研究将包括EtG尿液测试的新应用，能够检测酒精使用两天的时间类似于非法药物使用的尿液测试，大多数CM药物研究都是基于此。EtG结果将被用作研究成果，并作为针对酒精使用的CM干预的基础。此外，CM范例将包括在强化门诊（IOP）成瘾治疗中的二次强化。据推测，这种次要意外事件将导致IOP就诊率更高。120名AD-SMI成人将参加为期4周的诱导期（强化提供尿分析3次， 周）。在整个研究期间，所有受试者将接受SMI的常规治疗（TAU）和强化门诊（IOP）成瘾治疗。诱导期后，受试者将随机接受1）12周的戒酒CM（每周3次通过EtG尿检评估）和每周1次的IOP成瘾治疗强化;或2）12周的强化，每周3次尿检。主要结局将是通过EtG尿分析、呼气测醉器以及自我报告和临床医生报告的酒精使用评估的酒精使用变化。次要结局将是通过IOP临床医生报告以及独立管理数据来源和自我报告评估的IOP成瘾治疗出勤率的变化。其他成果将包括：非法药物使用的生物测量、自我报告的非法药物使用、精神症状、艾滋病毒风险、尼古丁使用以及昂贵的急诊科、住院精神病和住院成瘾治疗服务的利用。所有结果将在12周的干预和3个月的随访期间进行评估。这项拟议的研究解决了两个公共卫生优先事项-酒精使用和治疗出勤率低-在成年人的SMI人群中，这些困难特别普遍和有问题;并响应NIAAA PA-10-100，酒精使用障碍：治疗，服务研究和恢复（R 01）。

DESCRIPTION (provided by applicant): Novel EtG Based Contingency Management for Alcohol in the Severely Mentally Ill We propose to conduct a randomized clinical trial investigating the effect of a 12-week ethyl glucuronide (EtG) urinalysis based contingency management (CM) intervention on decreasing alcohol use and increasing alcohol treatment attendance among persons with alcohol dependence (AD) and serious mental illness (SMI) receiving long-term community mental health treatment. While CM is an evidence-based treatment for illicit drug use, research regarding its efficacy for AD has been limited due to the absence of a pragmatic alcohol biomarker to base the CM paradigm upon. This study will include the novel application of EtG urine-tests, capable of detecting alcohol use for a two-day period similar to urine-tests of illicit drug use, on which most CM drug research has been based. EtG results will be utilized as both a research outcome and as a basis on which the CM intervention targeting alcohol use is based. In addition, the CM paradigm will include secondary reinforcement of attendance in intensive outpatient (IOP) addiction treatment. It is hypothesized that this secondary contingency will result in higher rates of IOP attendance. 120 AD-SMI adults will participate in a 4-week induction period (reinforcement for providing urinalysis three times a week). All participants will receive treatment as usual (TAU) for SMI and intensive outpatient (IOP) addiction treatment throughout the study. After an induction period participants will be randomized to receive either 1) 12 weeks of CM for alcohol abstinence (assessed 3 times a week by EtG urine-tests) AND weekly reinforcement for IOP addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-tests 3 times a week. The primary outcome will be changes in alcohol use assessed by EtG urinalysis, breathalyzer, as well as self-reported and clinician-reported alcohol use. The secondary outcome will be changes in IOP addiction treatment attendance assessed by IOP clinician-report, as well as independent administrative data sources, and self-report. Other outcomes will include: biological measures of illicit drug use, self-reported illicit drug use, psychiatric symptoms, HIV-risk, nicotine use, and utilization f costly emergency department, inpatient psychiatric and residential addiction treatment services. All outcomes will be assessed across the 12-week intervention and a 3-month follow-up period. This proposed study addresses two public health priorities--alcohol use and poor treatment attendance--in a population of adults with SMI for whom these difficulties are especially prevalent and problematic; and is responsive to NIAAA PA-10-100, Alcohol Use Disorders: Treatment, Services Research, and Recovery (R01).