Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Drinking
研究概览
简要总结
This study will examine the neural mechanisms underlying both spontaneous behavior change and behavior change in response to a brief intervention among problem drinkers.
详细描述
Although problem drinkers (PD) are a less severe, highly prevalent sub-type of alcohol use disorder (AUD) who are more likely to undergo reductions in alcohol use, compared to more severe AUD, the underlying mechanisms that maintain PD, as well as the mechanisms that underlie both spontaneous and treatment- related behavior change in this population, are not well understood. This proposal takes a lab to life approach by combining functional neuroimaging (fMRI), ecological momentary assessment (EMA), and brief interventions (BI) in non-treatment seeking PD to test whether heightened incentive salience (reactivity) to alcohol cues and impaired ability to regulate cue-induce craving are the mechanisms that characterize PD, and play a role in behavior change vs. persistence of behavior. Identifying these mechanisms is critical for testing and understanding treatments and uncovering who is most likely to respond to interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Past or current severe AUD as defined by DSM- V
- •Currently seeking treatment or attempting to stop drinking
- •Past or current alcohol withdrawal symptoms
- •Current DSM-V diagnosis of substance use disorder (other than nicotine or caffeine).
- •Regular use (more than 1-2 times weekly) of recreational drugs.
- •Psychotic Disorder or Bipolar disorder
- •Severe depression (Patient Health Questionnaire score > 19) or anxiety (Beck Anxiety Inventory > 25)
- •Substantial risk of suicide or violence
- •MRI contraindications (e.g., metallic implants, pacemaker, weight > 350 lbs, waist > 55")
- •Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective
- •Objective cognitive impairment
- •Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. - Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II). Well-treated hypothyroidism will not be excluded.
- •Pregnant, lactating (participation allowed 3 months after ceasing lactation), or currently intending to become pregnant
- •Any history of ECT
- •Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury (LOC > 5 minutes), mental retardation
- •Diagnosed learning disability, dyslexia, or ADHD
- •For women: Current pregnancy or intention to be pregnant in the near future
结局指标
主要结局
Drinking
时间窗: 6 months
Heavy drinking days
次要结局
未报告次要终点
研究者
Nasir Naqvi
research psychiatrist
New York State Psychiatric Institute