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

描述(申请人提供)：新的基于EtG的酒精应急管理严重精神病患者我们建议进行一项随机临床试验，调查在接受长期社区精神卫生治疗的酒精依赖(AD)和严重精神疾病(SMI)患者中，基于乙基葡萄糖醛酸(EtG)尿液分析的应急管理(CM)干预在减少酒精使用量和增加酒精治疗使用率方面的效果。虽然CM是一种以证据为基础的治疗非法药物使用的方法，但由于缺乏实用的酒精生物标记物作为CM范例的基础，有关其对AD的疗效的研究一直受到限制。这项研究将包括EtG尿检的新应用，能够检测两天内的酒精使用，类似于非法药物使用的尿检，大多数CM药物研究都基于这种尿检。ETG结果将被用作研究结果，并作为针对酒精使用的CM干预的基础。此外，CM模式将包括在强化门诊(IOP)成瘾治疗中第二次加强护理。据推测，这种二次偶然事件将导致更高的眼压就诊率。120名AD-SMI成人将参加为期4周的诱导期(加强每年三次尿检 周)。在整个研究过程中，所有参与者都将接受SMI和强化门诊(IOP)成瘾治疗(TAU)。在诱导期后，参与者将被随机接受1)12周的CM戒酒(通过EtG尿检进行评估)和每周强化眼压成瘾治疗；或2)12周的强化治疗以提供每周3次的尿检。主要结果将是通过EtG尿液分析、呼气分析以及自我报告和临床医生报告的酒精使用情况评估酒精使用的变化。次要结果将是由眼压临床医生评估的眼压成瘾治疗就诊情况的变化-报告，以及独立的行政数据来源和自我报告。其他结果将包括：对非法药物使用、自我报告的非法药物使用、精神症状、艾滋病毒风险、尼古丁使用的生物衡量，以及对昂贵的急诊室、住院精神和住宅成瘾治疗服务的利用。所有结果将在为期12周的干预和3个月的随访期内进行评估。这项拟议的研究涉及两个公共卫生优先事项--酒精使用和糟糕的治疗出勤率--在患有SMI的成年人中，这些困难对他们来说特别普遍和有问题；并对NIAAA PA-10-100，酒精使用障碍：治疗、服务研究和康复(R01)做出回应。

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).