Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent of Heavy Drinking Days
研究概览
简要总结
The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.
详细描述
This study is the first to test if Alcohol approach-bias modification (ApBM), delivered through virtual reality, as an add-on to outpatient treatment can reduce heavy alcohol use and improve neuro-cognitive outcomes among Veterans with mild to moderate traumatic brain injury (mmTBI) engaged in outpatient treatment for alcohol use disorder (AUD).
This will be a Phase II double-blind, randomized, sham-controlled clinical trial. Approximately 100 heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild to moderate traumatic brain injury (mmTBI) will be randomized into the study to complete a 3-week of either personalized ApBM or sham training (9 training sessions). Immediately following the 3-week training, a post-intervention Week-4 assessment will be administered. The participants will also be re-assessed again at Week 12 as the last study visit.
The aims of the study are as follows:
Aim 1: Establish the efficacy of a personalized alcohol ApBM to promote recovery from AUD among heavy drinking Veterans with a history of mmTBI.
Aim 2: Evaluate alcohol ApBM related change in fMRI cue-induced craving outcomes of treatment response within Default Mode Network.
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
- Double (Participant, Investigator)
盲法说明
The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked.
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
- 否
入选标准
- •A history of mild-moderate TBI, as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury)
- •Heavy drinking defined by NIH/NIAAA criteria (>7 drinks/week for women; >14 drinks/week for men) for at least one week in the last 90 days
- •Moderate to severe criteria for current alcohol use disorder (AUD) by DSM-5
- •Participants must also be engaged in VA outpatient AUD treatment and express a desire to reduce, stop, or maintain cessation of alcohol use
排除标准
- •Unstable clinically significant psychiatric disorders or medical conditions that would create excessive risks, in the clinical judgment of the Principle Investigator
- •Current or history of the following:
- •intrinsic cerebral tumors
- •demyelinating and neurodegenerative diseases
- •arteriovenous malformations
- •cerebrovascular or peripheral vascular disease
- •severe or penetrating traumatic brain injury
- •documented learning disabilities
- •surgical implantation of neurostimulators or cardiac pacemakers and any other MRI contraindications
- •These conditions/diseases are known to influence the neurocognitive and MR-derived neurobiological measures proposed in this application
- •Female participant who is pregnant or actively attempting to conceive (to prevent any unnecessary exposure to high magnetic fields or radiofrequency energy to the unborn child)
- •Concurrent participation in another clinical trial on AUD or TBI study
- •Requiring acute medical detoxification from alcohol, based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
- •Legal mandate to participate in an alcohol treatment program
- •Presence of severe TBI or penetrating head trauma
- •Starting use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past 4 weeks (must be on AUD treatment for longer than 4 weeks)
研究组 & 干预措施
Sham Condition
Sham training will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible.
干预措施: Sham Condition (Behavioral)
Personalized VR Alcohol Approach Bias Modification (ApBM) Condition
The Personalized VR ApBM will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible.
干预措施: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition (Behavioral)
结局指标
主要结局
Percent of Heavy Drinking Days
时间窗: 90 days post-randomization
The primary endpoint is percent of heavy drinking days during the 90 days post-randomization into treatment. A heavy drinking day is defined using NIH/NIAAA criteria, drinking more than 4 drinks a day for men and more than 3 drinks a single day for women.
次要结局
- Cue-induced fMRI BOLD-signal craving activation contrasts(Week 4 - The week following completion of cognitive training.)