Alcohol Related Impairment and Reinforcement After Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Drive Safety RS-300 Research Driving Simulator Performance
研究概览
简要总结
The proposed project will help to understand the changes in reinforcement and impairment experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study the investigators propose to investigate RYGB patients with a prospective, longitudinal design. Investigators will examine driving impairment before and after surgery as well as study cognitive changes and reinforcement changes that may occur in RYGB patients while consuming alcohol. Finally, investigators aim to better characterize the changes that occur in the pharmacokinetics of alcohol following bariatric surgery and examine key variables which may play a role in the development in alcohol use disorders.
详细描述
The three major objectives of this NIH sponsored application are: 1) to characterize the severity of cognitive impairment and driving performance changes following alcohol consumption in a group of patients who have undergone Roux-en-Y Gastric Bypass (RYGB) bariatric surgery and 2) to investigate differential reinforcing properties of alcohol in patients before and after they undergo RYGB. Both of these objectives stem from observations from the investigators work and previous empirical studies suggesting that the pharmacokinetics (PK) of alcohol are substantially altered following bariatric surgery. This may lead to alterations in the time-course and severity of alcohol-related cognitive and driving impairment, as well as alter the reinforcing effects of drinking alcohol. Particularly relevant to these objectives, PK data have shown higher peak alcohol concentrations and a shorter time to achieve them in bariatric surgery patients. Therefore the third objective of this application is to better characterize the PK profile of alcohol following RYGB. Finally, investigators will explore whether changes in impairment, reinforcement, and PKs are moderated by gender, age, smoking, and alcohol use.
In this study investigators propose to prospectively investigate approximately 50-60 RYGB patients. Participants will be assessed at baseline (pre-surgery) and one year after surgery (to approximate their weight nadir) in an acute alcohol dosing laboratory paradigm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- 是
入选标准
- •Male or female (approximately 50% each)
- •21 - 65 years of age
- •In evaluation for Roux-en-Y gastric bypass surgery
- •Able to tolerate alcohol dose
- •Cognitive ability to complete study protocol as assessed at screening
- •Medically stable
排除标准
- •History of or current alcohol use disorder (as assessed at screening)
- •Psychotic or bipolar spectrum disorder (as assessed at screening)
- •Current suicidality (as assessed at screening)
- •Concomitant medication known to significantly interact with alcohol
- •Concomitant medication known to significantly impact driving simulator performance
- •Pregnancy or intending to become pregnant prior to the end of the their participation in the study or breastfeeding
- •Positive urine drug screen
- •Unable to tolerate blood draws
- •Significant risk for developing motion sickness while using the driving simulator
- •Unable to speak English
- •Other factor that would increase participant risk in the protocol in the judgement of the investigators or physician.
- •Participated in an investigational drug study within the past 30 days
- •Is or has an immediate family member that is employeed by the Neuropsychiatric Research Institute
- •Has a pacemaker
- •Insulin dependent diabetes mellitus
- •Smoking defined as regular use of nicotine in the past 6 months
- •A presurgery weight of > 400lbs at screening appointment or as reported on telephone screen
- •Unable to provide a blood sample at the screening appointment or is assessed to have poor vein quality for IV placement as determined by the research clinical personnel.
- •Laboratory abnormalities defined as a hepatic panel greater than three times the upper limit of normal, or fasting glucose of < 60 or >120 mg/dl, or positive pregnancy test.
结局指标
主要结局
Change in Drive Safety RS-300 Research Driving Simulator Performance
时间窗: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
We will be assessing participants for evidence of a change in driving impairment using the Drive Safety RS-300 Research Driving Simulator, which provides a high-quality, authentic automotive control environment based on a midsized Ford Focus passenger car. The simulation is controlled by a bank of computers running DriveSafety's Vection software, which enables real-time data collection and updating of the displays. DriveSafety's HyperDrive Authoring Suite is used to model complex driving scenarios and to precisely control the presentation of stimuli within the simulated environment.
次要结局
- Change in 2-Back task(Pre-surgery (up to 3 months before surgery) and 1 year post surgery)
- Change in Desire-for-Drug Scale(Pre-surgery (up to 3 months before surgery) and 1 year post surgery)
- Change in pharmacokinetics as measured via blood alcohol concentrations(Pre-surgery (up to 3 months before surgery) and 1 year post surgery)
研究者
Kristine Steffen
Research Scientist
Neuropsychiatric Research Institute, Fargo, North Dakota