Collaboration on Alcohol Self Administration in Adolescents and Young Adults - Specific Aim 2: To Examine the Effect of Acute Alcohol Administration on Forebrain Disinhibition Using Functional Magnetic Resonance Imaging (fMRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Alcohol consumption
研究概览
简要总结
Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity related to disinhibition measured with the Stop Signal task will be assessed during a continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at 60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor Aggression Paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. All participants will undergo an alcohol and a placebo fMRI session.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 19 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
- •written informed consent by the subject;
- •habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
- •at least one prior experience of alcohol intoxication
- •being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
- •effective contraception in female participants;
- •consenting to abstain from any illegal substance use for 2 weeks prior to participation;
- •living within 15 km (9.5 miles) from downtown Dresden;
- •sufficient information concerning alcohol use in both parents and in at least four second-degree relatives
排除标准
- •prior medical treatment due to alcohol use;
- •current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
- •current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
- •current or prior history of alcohol-induced flushing reactions;
- •positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
- •light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
- •intention to become pregnant
- •pregnancy or positive urine pregnancy screening or breast-feeding;
- •any alcohol intake on the test day or the day before;
- •use of medications known to interact with alcohol within 2 weeks of the study;
- •positive hepatitis or HIV at screening, provided the subject consented to these tests
- •any conditions posing safety issues with the fMRI scan, such as ferromagnetic implants, cardiac pacemakers or insulin pumps
结局指标
主要结局
Alcohol consumption
时间窗: 2 years
Alcohol consumption, as measured by a Timeline Followback Interview.
次要结局
- Absolute perfusion levels assessed with arterial spin labeling(1 week)
- Behavioural Stop Signal Reaction Time (SSRT)(1 week)
- BOLD fMRI correlate of aggression(1 week)
- Taylor aggression score(1 week)
- BOLD fMRI correlate of disinhibition(1 week)