Novel EtG BasedContingency 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: 9390731
• 负责人: Michael G McDonell
• 金额: $ 68.17万
• 依托单位: WASHINGTON STATE UNIVERSITY
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9390731
• 关键词: Abstinence; Adult; Affect; Alcohol consumption; Alcoholic beverage heavy drinker; Alcohols; American; Behavior Therapy; Biological Markers; Bipolar Disorder; Characteristics; Cigarette Smoker; Cocaine Dependence; Complex; Consumption; Cost Effectiveness Analysis; Costs and Benefits; Dropout; Drug resistance; Drug usage; Drug user; Economics; Emotional; Executive Dysfunction; Funding; Glucuronides; HIV Infections; HIV risk; Heavy Drinking; Homelessness; Hospitalization; Hour; Incentives; Individual; Intervention; Journals; Light; Major Depressive Disorder; Mentally Ill Persons; Modification; National Institute on Alcohol Abuse and Alcoholism; Nicotine Dependence; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Population; Psychiatry; Psychological reinforcement; Randomized; Recruitment Activity; Recurrence; Reporting; Research; Rewards; Risk Behaviors; Sampling; Schizophrenia; Shapes; Testing; Theoretical model; Time; Treatment outcome; Urine; addiction; alcohol abstinence; alcohol abuse therapy; alcohol measurement; alcohol reinforcement; alcohol reward; alcohol use disorder; base; cigarette smoking; comparative efficacy; contingency management; cost; cost effective; cost effectiveness; drinking; drug abstinence; executive function; experience; follow-up; improved outcome; incentive salience; novel; primary outcome; randomized trial; reinforcer; relative cost; secondary outcome; severe mental illness; treatment as usual; treatment response; week trial

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.

抽象的 这种竞争延续（续订）应用的目的是确定是否修改 应急管理（CM）干预改善了预后，并降低了饮酒者的成本 严重的精神疾病（SMI）。多达46％的SMI成年人一生都患有酒精疾病。 饮酒有助于高度无家可归的发生率，精神病住院，艾滋病毒感染，香烟 在该人群中吸烟和吸毒，CM是一种特别有前途的治疗方法。在CM中，患者 获得明显的奖励，以证明戒毒。饮酒的CM需要一个可以的生物标志物 消费后检测超过48小时的酒精使用。因为没有这样的生物标志物直到 最近，很少的研究调查了CM作为饮酒障碍的治疗方法。在我们的最初资金中 时期我们发现酒精生物标志物乙基糖苷（ETG）可以检测到最多5天的饮酒 作为CM的随机12周试验的一部分。那些随机到基于ETG的CM的人是3次 比对照组更有可能提交酒精阴性ETG测试。 CM参与者的重量也较低 饮酒，刺激性吸毒和吸烟比对照组。但是，CM对参与者无效 近期大量饮酒（ETG> 499 ng/mL）的平均预处理ETG水平经常表明。我们 提议调查2种策略 - a）增加加强量或b）增强轻饮用 在加强禁欲之前 - 可以通过SMI改善饮酒者的结果。同时最初的研究 表明这些策略与耐药药物使用者的结果改善有关 吸烟者，没有随机试验对其进行比较，在酒精使用者或成年人中调查了它们 SMI，研究了它们的相对成本效益，或使用理论调查了CM有效性的修饰符 模型。因此，我们将比较这两种方法的效率 与SMI的大量饮酒者的最初资助期。总共400名参与者像往常一样接受治疗 治疗机构将参加为期4周的入选期。参与者（n = 240）达到平均etg> 在感应期间的499 ng/ml将随机分为a）4个月的标准级别 用于提交酒精含ETG样品（ETG <100 ng/ml）（通常CM）的加固CM，b）4个月 用于提交酒精含量ETG样品（高磁性CM）或C）1个月CM的高磁性CM 用于提交指示饮酒的酒精样品（ETG <500 ng/ml），然后进行3个月的CM 提交含酒精的ETG样品（成型CM）。主要结果将是ETG验证的酒精 在治疗的最后三个月（所有强化取决于禁欲时）和戒酒 在6个月的随访中。我们还将研究次级结果的群体差异，进行 CM条件的全面经济分析，并确定构成NIAAA的变量是否是 在3 cm条件下，成瘾神经临床评估框架中度戒酒。