Alcohol Related Impairment and Reinforcement: Pre to Post Roux en Y Gastric Bypass Surgery

Not Applicable

• Conditions: Bariatric Surgery Candidate
• Interventions: Other: Alcohol

• Registration Number: NCT02370732
• Lead Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28
• Primary Completion: 2018-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female (approximately 50% each)
2. 21 - 65 years of age
3. In evaluation for Roux-en-Y gastric bypass surgery
4. Able to tolerate alcohol dose
5. Cognitive ability to complete study protocol as assessed at screening
6. Medically stable

Exclusion Criteria

1. History of or current alcohol use disorder (as assessed at screening)
2. Psychotic or bipolar spectrum disorder (as assessed at screening)
3. Current suicidality (as assessed at screening)
4. Concomitant medication known to significantly interact with alcohol
5. Concomitant medication known to significantly impact driving simulator performance
6. Pregnancy or intending to become pregnant prior to the end of the their participation in the study or breastfeeding
7. Positive urine drug screen
8. Unable to tolerate blood draws
9. Significant risk for developing motion sickness while using the driving simulator
10. Unable to speak English
11. Other factor that would increase participant risk in the protocol in the judgement of the investigators or physician.
12. Participated in an investigational drug study within the past 30 days
13. Is or has an immediate family member that is employeed by the Neuropsychiatric Research Institute
14. Has a pacemaker
15. Insulin dependent diabetes mellitus
16. Smoking defined as regular use of nicotine in the past 6 months
17. A presurgery weight of > 400lbs at screening appointment or as reported on telephone screen
18. 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.
19. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Roux en Y Gastric Bypass	Alcohol	Participants recruited for this protocol will be those planning to undergo Roux-en-Y Gastric Bypass (RYGB). Upon study screening completion, participants will take part in a total of 4 laboratory assessment days where a fixed dose of alcohol will be given. * 2 pre-surgery research appointments where participants will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day. * 2 post-surgery (1 year) research appointments where you will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day.

Primary Outcome Measures

Name	Time	Method
Change in Drive Safety RS-300 Research Driving Simulator Performance	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.

Secondary Outcome Measures

Name	Time	Method
Change in 2-Back task	Pre-surgery (up to 3 months before surgery) and 1 year post surgery	We will be assessing cognitive impairment using the 2-Back task. This task is a complex working memory task in which a series of 15 consonants is presented visually. Participants are asked to make a yes/no response following each consonant - whether it is the same as, or different from, the consonant presented two earlier.
Change in Desire-for-Drug Scale	Pre-surgery (up to 3 months before surgery) and 1 year post surgery	The Desire-for-Drug Scale is a 4-item VAS measure commonly used in research on alcohol priming effects that study increases in motivation to drink after a dose of alcohol (e.g., Fillmore, 2001). The scale measures the motivation to consume alcohol (i.e., priming), assesses subjective ratings of its effect, and is viewed as an indicator of the reward a person associates with alcohol consumption. The measure of priming is assessed by an item that asks participants how much they "have a desire for alcohol".
Change in pharmacokinetics as measured via blood alcohol concentrations	Pre-surgery (up to 3 months before surgery) and 1 year post surgery	Pharmacokinetic assessments of alcohol plasma levels and will be analyzed using model-independent (noncompartmental) methods with the use of Phoenix WinNonlin® Version 6.1 (Pharsight, Mountain View, CA).

Trial Locations

Locations (1)

Neuropsychiatric Research Institute; 🇺🇸 Fargo, North Dakota, United States