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

Alcohol Related Impairment and Reinforcement After Gastric Bypass Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Other: Alcohol

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • Neuropsychiatric Research Institute
      • Contact: Ron Erickson; Phone Number: 701-293-1335

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Roux en Y Gastric Bypass; 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.

Other: Alcohol; A weight based dose of alcohol will be administered during each study day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Drive Safety RS-300 Research Driving Simulator Performance	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.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Desire-for-Drug Scale	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".	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in pharmacokinetics as measured via blood alcohol concentrations	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).	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in 2-Back task	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.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Structured Clinical Interview for DSM (SCID-I/P; First et al., 1995)	The SCID-I/P will provide a thorough assessment of Axis I psychopathology in order to examine the impact of co-occurring psychiatric disorders on the parameters of interest.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Addiction Severity Index (ASI)	The ASI will be used to carefully examine alcohol and drug abuse frequency and severity	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Alcohol Use Disorders Identification Test (AUDIT; Barbor, et al., 2001)	The AUDIT is a ten-item measure developed by the World Health Organization to assess alcohol use and alcohol-related consequences.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Michigan Alcohol Screening Test (MAST; Selzer, 1971)	The MAST is a 25-item questionnaire which aims to screen for lifetime alcohol-related problems and alcoholism.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Fagerstrom Test for Nicotine Dependence and Heaviness of Smoking (FTQ; Heatherton et al., 1991)	The FTQ provides a brief self-report measure of nicotine dependence.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Yale Food Addiction Scale (YFAS; Gearhardt et al., 2009)	The YFAS purports to assess markers of substance dependence in relation to the consumption of high fat and high sugar foods.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	The DERS is a 36- item self-report measure of emotion dysregulation, providing a total score and six subscale scores: limited access to adaptive emotion regulation strategies, lack of emotional clarity, lack of emotional awareness, impulse control problems when distressed, problems maintaining goal-focused behavior when distressed, and non-acceptance of negative emotions.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in UPPS-P Impulsive Behavior Scale (UPPS-P; Whiteside & Lynam, 2001)	The UPPS-P is a 59-item self-report questionnaire that assesses five different kinds of impulsivity: negative urgency, positive urgency, sensation seeking, lack of perseverance, and lack of premeditation.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Adult Temperament Questionnaire-Short Form (ATQ-SF; Evans & Rothbart, 2007)	The ATQ-SF is a self-report measure of adult temperament traits that contains several subscales. In the current study, only the 19-item Effortful control subscale will be used, which assesses attentional control, control over behavioral activation, and control over behavioral inhibition.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Emotional Eating Scale (EES; Arnow, Kenardy, & Agras, 1995)	The EES is a self-report measure which purports to assess the extent to which individuals cope with negative affect through eating behavior. It includes three subscales: Anger/Frustration, Anxiety, and Depression.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in Eating Disorder Examination Overeating Section (EDE; Fairburn, 2008)	The overeating section of the EDE will be used to assess overeating, binge eating, and loss of control eating in this sample.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in SCID-I/P Impulse Control Module (First et al., 1995; Muller et al., 2009)	The Impulse Control module will be used to measure compulsive buying, gambling, trichotillomania, skin picking, shoplifting, internet use, sexual behavior, intermittent explosive disorder, kleptomania, and pyromania.	Pre-surgery (up to 3 months before surgery) and 1 year post surgery

Collaborators and Investigators

• Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
• Collaborators: University of Kentucky; Kent State University; North Dakota State University
• Investigators: Principal Investigator: Kristine Steffen, PharmD, PhD, Neuropsychiatric Research Institute; Principal Investigator: Scott Engel, PhD, Neuropsychiatric Research Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Alcohol; Bariatric Surgery; Roux en Y Gastric bypass; Alcohol impairment; Alcohol reinforcement; Alcohol pharmacokinetics
• Other Study ID Numbers: AA022336