Novel EtG BasedContingency Management for Alcohol in the Severely Mentally Ill

摘要 该竞争延续(续订)申请的目标是确定对 应急管理(CM)干预改善酗酒者的预后并降低成本 严重精神疾病(SMI)。多达46%的患有SMI的成年人在他们的一生中经历了酒精使用障碍。 酗酒会导致无家可归、精神病院住院、艾滋病毒感染、吸烟的高比率 吸烟和吸毒，对于这些人群来说，CM是一种特别有希望的治疗方法。在CM中，患者 因表现出戒毒行为而获得切实奖励。用于酒精的CM需要一种生物标记物 检测饮酒后超过48小时的饮酒情况。因为这样的生物标记物直到 最近，很少有研究将中药作为酒精使用障碍的治疗方法。在我们的初始资金中 期间我们发现酒精生物标志物乙基葡萄糖醛酸乙酯(EtG)可以检测到饮酒长达5天 作为为期12周的CM随机试验的一部分。那些被随机分配到基于EtG的CM的人是3次 与对照组相比，更有可能提交酒精阴性的EtG测试。CM参与者的体重水平也较低 与对照组相比，饮酒、使用兴奋剂和吸烟均有显著差异。然而，CM对参与者无效 治疗前的平均EtG水平表明最近经常大量饮酒(EtG&GT；499 ng/毫升)。我们 建议调查两种策略--a)增加增强剂的量，还是b)加强少量饮酒 在加强戒酒之前-可以改善重度酗酒者的预后。虽然最初的研究 表明这些策略与改善耐药吸毒者的结果有关， 吸烟者，没有随机试验对他们进行比较，调查他们在饮酒者或成年人中与 SMI，调查了它们的相对成本效益，或使用理论上的 模特。因此，我们将比较这两种方法对实施的CM干预的效果 重度饮酒者SMI的初始资助期。共有400名参与者在2点照常接受治疗 治疗机构将参加为期4周的诱导期。受试者(n=240)，平均EtG和GT； 诱导期内的每毫升499 ng将被随机分为a)4个月的标准量 用于提交戒酒EtG样本的加固CM(EtG和lt；100 ng/mL)(通常CM)，b)4个月 用于提交戒酒EtG样本的高级别CM(高级别CM)，或c)1个月CM 提交表明少量饮酒的酒精样本(EtG&lt；500 ng/mL)，然后进行3个月的CM 提交戒酒EtG样本(Shaping CM)。主要结果将是经EtG证实的酒精 在最后3个月的治疗中禁欲(当所有强化都取决于禁欲)和 在6个月的随访中。我们还将调查二次结局中的组差异，进行 对CM条件进行全面的经济分析，并确定构成NIAAA的变量 成瘾神经临床评估框架在3 CM条件下中度戒酒。

ABSTRACT The objective of this competing continuation (renewal) application is to determine whether modifications to a contingency management (CM) intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness (SMI). Up to 46% of adults with SMI experience an alcohol use disorder in their lifetimes. Alcohol use contributes to high rates of homelessness, psychiatric hospitalization, HIV infection, cigarette smoking, and drug use in this population, for which CM is an especially promising treatment. In CM, patients receive tangible rewards for demonstrating drug abstinence. CM for alcohol use requires a biomarker that can detect alcohol use for more than 48 hours after consumption. As no such biomarker was available until recently, little research has investigated CM as a treatment for alcohol use disorders. In our initial funding period we found that the alcohol biomarker ethyl glucuronide (EtG) can detect drinking for up to 5 days when administered as part of a randomized 12-week trial of CM. Those randomized to EtG-based CM were 3 times more likely to submit alcohol-negative EtG tests than controls. CM participants also had lower levels of heavy drinking, stimulant drug use, and cigarette smoking than controls. However, CM was ineffective for participants with an average pre-treatment EtG level that indicated frequent, recent heavy drinking (EtG > 499 ng/mL). We propose to investigate whether 2 strategies – a) increasing reinforcer magnitude or b) reinforcing light drinking before reinforcing abstinence – can improve outcomes in heavy drinkers with SMI. While initial research indicates that these strategies are associated with improved outcomes in treatment-resistant drug users and cigarette smokers, no randomized trial has compared them, investigated them in alcohol users or adults with SMI, investigated their relative cost-effectiveness, or investigated modifiers of CM efficacy using a theoretical model. Therefore, we will compare the efficacy of these 2 approaches to the CM intervention implemented in the initial funding period in heavy drinkers with SMI. A total of 400 participants receiving treatment as usual at 2 treatment agencies will take part in a 4-week induction period. Participants (n=240) who attain a mean EtG > 499 ng/mL during the induction period will be randomized to either a) 4 months of standard-magnitude reinforcement CM for submitting alcohol-abstinent EtG samples (EtG < 100 ng/mL) (Usual CM), b) 4 months of high-magnitude CM for submitting alcohol-abstinent EtG samples (High-Magnitude CM), or c) 1 month of CM for submitting alcohol samples that indicate light drinking (EtG < 500 ng/mL), followed by 3 months of CM for submitting alcohol-abstinent EtG samples (Shaping CM). The primary outcome will be EtG-verified alcohol abstinence during the last 3 months of treatment (when all reinforcement is contingent on abstinence) and during 6 months of follow-up. We will also investigate group differences in secondary outcomes, conduct a comprehensive economic analysis of CM conditions, and determine whether variables that make up the NIAAA Addictions Neuroclinical Assessment framework moderate alcohol abstinence in the 3 CM conditions.