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

基于 EtG 的新型严重精神疾病患者酒精应急管理

• 批准号: 8232535
• 负责人: Michael G McDonell
• 金额: $ 34.73万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-10 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8232535
• 关键词: Accident and Emergency department; Address; Adult; Affect; Alcohol consumption; Alcohol dependence; Alcohols; Behavior Therapy; Behavioral; Biological; Biological Markers; Bipolar Disorder; Breath Tests; Chronic; Communities; Community Mental Health Centers; Data Sources; Detection; Dropout; Drug usage; Early treatment; Ensure; Evidence based treatment; Funding; Glucuronides; Goals; HIV; HIV Infections; Health; Health Services Research; Homelessness; Hospitalization; Hour; Illicit Drugs; Individual; Ingestion; Inpatients; Intervention; Major Depressive Disorder; Measurement; Measures; Mental Health; Mentally Ill Persons; Monitor; National Institute on Alcohol Abuse and Alcoholism; Nature; Nicotine; Outcome; Outcomes Research; Outpatients; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Population; Psychiatric therapeutic procedure; Psychological reinforcement; Public Health; Publishing; Randomized; Randomized Clinical Trials; Recovery; Relapse; Reporting; Research; Risk; Risk Behaviors; Schizophrenia; Services; Severities; Severity of illness; Symptoms; Testing; Time; United States National Institutes of Health; Urinalysis; Urine; addiction; alcohol abstinence; alcohol abuse therapy; alcohol use disorder; base; behavioral impairment; breath alcohol measurement; contingency management; drug craving; drug of abuse; experience; follow-up; high risk; improved; innovation; novel; post intervention; primary outcome; psychostimulant; public health priorities; reduced alcohol use; reinforcer; secondary outcome; severe mental illness; therapy design; treatment as usual

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). PUBLIC HEALTH RELEVANCE: Alcohol dependence disproportionately affects persons with co-occurring severe mental illnesses, such as schizophrenia, bipolar disorders, and chronic major depression, with consequences such as early treatment dropout, increased psychiatric hospitalization, psychiatric illness severity, HIV-risk, and nicotine use. This project proposes to evaluate a behavioral treatment, contingency management, that has strong support as a treatment for reducing drug use, but has been less researched as a treatment for alcohol use because of limitations of alcohol biomarkers, such as alcohol breath-tests. We propose to determine if a contingency management intervention that reinforces 1) alcohol abstinence, as assessed by the alcohol biomarker -ethyl glucuronide- and 2) outpatient alcohol treatment attendance results in reductions in alcohol use and increases in treatment attendance in 120 adults suffering from alcohol dependence and severe mental illness receiving treatment at an urban community mental health center.

描述（由申请人提供）：基于 EtG 的新型严重精神疾病患者酒精应急管理 我们建议开展一项随机临床试验，调查基于 12 周乙基葡萄糖醛酸 (EtG) 尿液分析的应急管理 (CM) 干预对减少酒精使用和增加接受长期社区心理健康治疗的酒精依赖 (AD) 和严重精神疾病 (SMI) 患者的酒精治疗就诊率的影响。虽然 CM 是一种针对非法药物使用的循证治疗方法，但由于缺乏基于 CM 范式的实用酒精生物标志物，有关其治疗 AD 疗效的研究受到限制。这项研究将包括 EtG 尿液测试的新应用，能够检测两天内的酒精使用情况，类似于非法药物使用的尿液测试，大多数 CM 药物研究都是以此为基础的。 EtG 结果将被用作研究成果和针对饮酒的 CM 干预的基础。此外，CM 范式将包括二次加强强化门诊 (IOP) 成瘾治疗的出勤率。据推测，这种次要意外事件将导致 IOP 就诊率提高。 120 名 AD-SMI 成人将参加为期 4 周的诱导期（强化为提供 3 次尿液分析） 星期）。在整个研究过程中，所有参与者都将照常接受 SMI 治疗 (TAU) 和强化门诊 (IOP) 成瘾治疗。诱导期后，参与者将被随机接受 1) 12 周的戒酒 CM（通过 EtG 尿液测试每周评估 3 次）和每周强化 IOP 成瘾治疗；或 2) 每周 3 次尿检强化 12 周。主要结果将是通过 EtG 尿液分析、呼气分析仪以及自我报告和临床医生报告的酒精使用情况评估的酒精使用变化。次要结果将是由 IOP 临床医生报告以及独立管理数据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室、住院精神科和住院成瘾治疗服务的利用。所有结果都将在 12 周的干预和 3 个月的随访期内进行评估。这项拟议的研究解决了患有 SMI 的成年人群体中的两个公共卫生优先事项——饮酒和治疗出勤率低，这些困难对他们来说尤其普遍和成问题；并响应 NIAAA PA-10-100，酒精使用障碍：治疗、服务研究和康复 (R01)。 公共卫生相关性：酒精依赖对同时患有严重精神疾病（例如精神分裂症、双相情感障碍和慢性重度抑郁症）的人影响尤为严重，其后果包括早期放弃治疗、增加精神病住院治疗、精神疾病严重程度、艾滋病毒风险和尼古丁使用。该项目建议 评估一种行为治疗，即应急管理，作为减少药物使用的治疗方法得到了强有力的支持，但由于酒精生物标志物（例如酒精呼气测试）的局限性，作为酒精使用治疗方法的研究较少。我们建议确定应急管理干预措施是否能加强 1) 戒酒（通过酒精生物标志物 - 乙基葡萄糖醛酸- 进行评估）和 2) 门诊酒精治疗出勤率，从而减少 120 名在城市社区精神卫生中心接受治疗的患有酒精依赖和严重精神疾病的成年人的饮酒量并增加治疗出勤率。