Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 4
- 主要终点
- Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine
研究概览
简要总结
The investigators will evaluate the efficacy of a 2 various contingency management (CM) interventions (High-Magnitude CM, Shaping CM) for treating heavy drinking among individuals with serious mental illness and alcohol dependence who are seen within the context of a community mental health center setting. Participants will be 400 adults diagnosed with serious mental illness and alcohol dependence and those who demonstrate heavy drinking during the first 4 weeks will be randomized to receive treatment conditions.
详细描述
The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence.
The investigators propose to examine whether 2 strategies - 1. Increasing reinforcer magnitude (High-Magnitude CM) or 2. Reinforcing light drinking before reinforcing abstinence (Shaping CM) - can improve outcomes in heavy drinkers with serious mental illness. The investigators will compare the efficacy of these 2 approaches to Usual CM in heavy drinkers with serious mental illness.
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 > 349 ng/mL (heavy drinking) during the induction period will be randomized to either a) 4 months of standard-magnitude CM for submitting alcohol-abstinent EtG samples (EtG < 150 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 12 months of follow-up.
The investigators will also examine group differences in secondary outcomes, conduct a comprehensive economic analysis, and determine whether variables that make up the NIAAA Addictions Neuroclinical Assessment (ANA) model moderate alcohol abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 65 years.
- •4 or more standard drinks for females (AFAB)/ 5 or more standard drinks for males (AMAB) on 5 or more occasions in the past 30 days.
- •DSM-5 diagnosis of moderate to severe alcohol use disorder.
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode).
排除标准
- •Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days
- •A significant risk of medically dangerous alcohol withdrawal (e.g. a history of seizures in the last 12 months, participant or clinician concern that abstinence will induce dangerous alcohol withdrawal).
- •Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
- •Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia)
- •Pregnant or planning to become pregnant.
结局指标
主要结局
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine
时间窗: During weeks 5 -16 of treatment
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)
次要结局
- Urinanalysis for Drug Use(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure))
- Addiction Severity Index (ASI)(Baseline, week 4, 8, 12, 16 through study completion)
- Alcohol and Cigarette Timeline Followback(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure))
- Fagerstrom Test of Nicotine Dependence(Baseline, week 4, 8, 12, 16 through study completion)
- Brief HIV Risk Behavior Scale(Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion)
- Positive and Negative Syndrome Scale(At baseline, week 4, 8, 12, 16 through study completion)
- Urinanalysis for Drug Use(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure))
- Addiction Severity Index (ASI)(Baseline, week 4, 8, 12, 16 through study completion)
- Alcohol and Cigarette Timeline Followback(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure))
- Fagerstrom Test of Nicotine Dependence(Baseline, week 4, 8, 12, 16 through study completion)
- Housing Timeline FollowBack(Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion)
- Brief HIV Risk Behavior Scale(Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion)
- NIH Toolbox Emotion Battery(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion)
- NIH Toolbox Cognition Battery(Baseline, weeks 20, 47, 71)
- Obsessive-Compulsive Drinking Scale(Baseline, 16 weeks of treatment (repeated measure) through study completion)
- Stimulus-Response Compatibility Task(Baseline, weeks 20, 47, 71)
- Stages of Change Readiness and Treatment Eagerness Scale(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion)
- Treatment Experiences and Expediencies Questionnaire(Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion)
研究者
Michael McDonell
Professor
Washington State University