Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Occupancy of KOR by NTX and Drinking
研究概览
简要总结
The primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has been approved for the treatment of alcohol dependence. Receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking behavior. This study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. We will use PET (positron emission tomography) for this study. PET is a type of imaging device found in nuclear medicine. It is used for tracking the presence of injected radioactive materials in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21-50
- •Able to read English at 6th grade level or higher and to complete study evaluations
- •Regular alcohol drinker
排除标准
- •Individuals who are seeking alcohol treatment
- •Medical conditions that would contraindicate the use of study medication
- •Regular use of other substances
研究组 & 干预措施
Naltrexone
干预措施: Naltrexone (Drug)
结局指标
主要结局
Occupancy of KOR by NTX and Drinking
时间窗: 6-8 days after treatment with naltrexone
To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
Relationship Between NTX Responsivity and Occupancy of KOR
时间窗: 6-8 days after treatment with naltrexone
To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers. Evaluations were done with a logistic regression which included years of drinking (a covariate), family history status, and occupancy of KOR. The logistic model calculated a probability of response, defined as a 50% or greater reduction in drinking after naltrexone, for every participant. Reported outcome is the area under the ROC produced by the model. The closer the value is to 100 percent probability, the better the model is at correctly classifying the observations.
次要结局
- Baseline KOR Differences(at baseline prior to treatment with naltrexone)