Imaging Alcohol Induced Dopamine Release in the Human Brain: a PET/[11C](+)PHNO Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in PHNO Binding Potential
研究概览
简要总结
The purpose of this study is to examine whether there is an increase in dopamine levels in the human striatum following an oral administration of alcohol, as has been evidenced in animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer, [11C]-(+)-PHNO (11C]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).
详细描述
This will be a within subjects study in 8 heavy drinkers ages 21-45. The within factors will be PET scans following an alcoholic beverage and following a non-alcoholic beverage. Participants will also have a baseline session prior to the scans where they will complete various cognitive tasks and questionnaires. During each PET scan, subjective drug effects as well as heart rate, blood pressure, blood alcohol content and cortisol levels will be collected. The change in PHNO binding potential between the two scan conditions will be the primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females of any ethnic origin between 21 and 45 years old.
- •Reported consumption of at least two heavy drinking episodes (according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criterion of 5 drinks for males or 4 for females) in the past 30 days prior to assessment.
- •Willing and capable to provide written informed consent
- •Good command of the English language
排除标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of alcohol dependence; receiving treatment for alcohol dependence
- •Taking medications or have any medical condition for which alcohol is contraindicated
- •Any medical condition requiring immediate investigation or treatment
- •Previous head trauma/neurological condition such as clinically significant history of seizure disorder, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past intracranial surgery
- •Beck Depression Inventory score >16
- •Current active or past suicidal ideation
- •Pregnancy tested by urine and blood screen each PET study day or lactation
- •Current DSM-IV diagnosis of any Axis I psychiatric disorder
- •Regular use of any therapeutic or recreational psychoactive drug use during the last three months (with the exception of nicotine and alcohol) or other substance use disorder (including nicotine)
- •Abnormal body mass (as defined as not within 20% of normal body mass index).
- •Current past or anticipated exposure to radiation exceeding 20 mSv in the last year.
- •Metal implants or paramagnetic objects within the body which may interfere with the magnetic resonance imaging (MRI).
- •Claustrophobia or a history of panic attacks
- •Abnormal clinical laboratory findings including serum creatinine greater than 2.0 mg/dl, abnormal liver function tests, elevated serum bilirubin (more than 1.5 times upper limit of normal), or pre-trial electrocardiogram (EKG) results demonstrating clinical significant abnormality
研究组 & 干预措施
alcoholic beverage
95% USP alcohol given at a dose of 1.5 g/l of body water mixed with orange juice and tonic water.
干预措施: alcoholic beverage (Drug)
non-alcoholic beverage
Orange juice and tonic water.
干预措施: non-alcoholic beverage (Drug)
结局指标
主要结局
Change in PHNO Binding Potential
时间窗: 2 weeks
Following the injection of the positron-emitting radiotracer \[11C\]-(+)-PHNO, binding of this radiotracer to dopamine receptors (DR) D2/3 will be measured using the PET scanner. As dopamine also binds to DR D2/3, either an increase or decrease in dopamine levels will either decrease or increase PHNO occupancy respectively. \[11C\]-(+)-PHNO binding potential will be measured on two different conditions (alcoholic beverage vs non-alcoholic beverage) on two separate days.
次要结局
- Subjective effects of alcohol(2 weeks)
- Objective effects of alcohol(2 weeks)
研究者
Bernard Le Foll
Principal Investigator; MD, PhD, CCFP
Centre for Addiction and Mental Health