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: 9761398
• 负责人: Michael G McDonell
• 金额: $ 80.59万
• 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/9761398
• 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; Cost-Benefit Analysis; 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; 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; recruit; 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 此竞争性延续（更新）申请的目的是确定是否对 应急管理 (CM) 干预可改善重度饮酒者的结果并降低成本 患有严重精神疾病 (SMI) 的成年人中，高达 46% 的人一生中都经历过酒精使用障碍。 饮酒会导致无家可归、精神病住院、艾滋病毒感染、吸烟等高比例 对于该人群中的吸烟和吸毒，CM 是一种特别有前景的治疗方法。 因戒毒而获得实际奖励需要一种生物标记物。 检测饮酒后 48 小时以上的饮酒情况，因为在此之前还没有此类生物标记物。 最近，在我们的初始资助中，很少有研究调查 CM 作为酒精使用障碍的治疗方法。 在此期间，我们发现酒精生物标记物乙基葡萄糖醛酸 (EtG) 可以在长达 5 天内检测饮酒情况 作为为期 12 周的随机 CM 试验的一部分，随机接受基于 EtG 的 CM 的患者为 3 次。 与对照组相比，CM 参与者更有可能出现酒精测试呈阴性，重度酒精浓度也较低。 与对照组相比，饮酒、使用兴奋剂药物和吸烟的情况有所改善。但是，CM 对参与者无效。 治疗前平均 EtG 水平表明近期频繁饮酒（EtG > 499 ng/mL）。 调查是否有 2 种策略 – a) 增加强化强度或 b) 强化少量饮酒 在加强戒酒之前——可以改善患有 SMI 的重度饮酒者的结果。 表明这些策略与改善耐药吸毒者的结果有关，并且 吸烟者，没有随机试验对他们进行比较，也没有在酗酒者或患有烟瘾的成年人中调查他们 SMI 研究了它们的相对成本效益，或使用理论研究了 CM 功效的调节剂 因此，我们将比较这两种方法在 CM 干预中的效果。 首次资助期间，患有 SMI 的重度饮酒者共有 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，达到平均 EtG > 的参与者 (n=240)。 诱导期内 499 ng/mL 将被随机分配至 a) 4 个月的标准量值 针对酒精提交戒酒 EtG 样本 (EtG < 100 ng/mL) 的强化 CM（普通 CM），b) 4 个月 用于提交戒酒 EtG 样本的高量级 CM（高量级 CM），或 c) 1 个月的 CM 提交表明轻度饮酒的酒精样本 (EtG < 500 ng/mL)，然后进行 3 个月的 CM 提交戒酒 EtG 样本（Shaping CM） 主要结果将是经过 EtG 验证的酒精。 在治疗的最后 3 个月期间禁欲（当所有强化都以禁欲为条件时）以及 在 6 个月的随访期间，我们还将调查次要结果的组间差异，并进行评估。 对 CM 条件进行综合经济分析，并确定构成 NIAAA 的变量是否 成瘾神经临床评估框架在 3 CM 条件下适度戒酒。