Investigating a Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Alcohol Craving
研究概览
简要总结
Background:
Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person s social behavior and brain structure, but researchers don t have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking.
Objectives:
To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking.
Eligibility:
Adults ages 21 65 who have an alcohol use disorder.
Healthy volunteers ages 21 65
Design:
Participants will be screened with
Physical exam
Medical history
Blood, urine, and heart tests
Mental health interview
Questions about their alcohol drinking.
At each session, participants will have:
A urine test for drugs and pregnancy. If they test positive, they cannot participate.
A breath alcohol test and assessment for alcohol withdrawal.
Participants will complete surveys, talk to researchers about behaviors, and play games.
Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1 2 hours.
Participants will do tasks in the scanner:
They will look at pictures, sometimes of alcohol.
They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else s changes.
Participants may have follow-up phone questions at least 3 times over about 6 months.
详细描述
Study Description:
In the first stage, participants will undergo functional magnetic resonance imaging while looking at socioemotional stimuli and alcohol cues and will pilot a neurofeedback training protocol. Personality traits and executive function will also be investigated. In the second stage, inpatient participants with alcohol use disorder will be randomly assigned to receive active or sham neurofeedback. Participants will undergo two functional magnetic resonance imaging sessions including looking at socioemotional stimuli and alcohol cues, resting state fMRI, and real time neurofeedback during alcohol craving. Ability to inhibit attention to alcohol cues and craving will be assessed prior to and following the neurofeedback as well. Participants will be contacted approximately 1 month, 3 months, and 6 months post release from inpatient treatment to assess outcomes.
Objectives:
The purpose of this protocol is to understand the mechanism whereby neural processes of socioemotional cognition associated with alcohol use disorders lead to negative drinking consequences. This study is a two-stage procedure to both provide evidence of a response modulation deficit associated with socioemotional processing in individuals with alcohol use disorder and investigate how moderating that deficit affects socioemotional processing and negative drinking consequences.
Endpoints:
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, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Alcohol Craving
时间窗: Acute, 1, 3, 6 months
Self-report craving, change in cue reactivity
Alcohol Attention Bias
时间窗: Acute, 1, 3, 6 months
Socioemotional Alcohol Attention Task
次要结局
- Community functioning(1, 3, 6 months)
- Antisocial behavior(1, 3, 6 months)
- Alcohol consumption(1, 3, 6 months)