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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02370732
Recruitment Status : Unknown
Verified September 2016 by Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota.
Recruitment status was:  Recruiting
First Posted : February 25, 2015
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
University of Kentucky
Kent State University
North Dakota State University
Information provided by (Responsible Party):
Kristine Steffen, 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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Other: Alcohol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Alcohol Related Impairment and Reinforcement After Gastric Bypass Surgery
Study Start Date : February 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Drive Safety RS-300 Research Driving Simulator Performance [ Time Frame: 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 :
  1. Change in Desire-for-Drug Scale [ Time Frame: 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".

  2. Change in pharmacokinetics as measured via blood alcohol concentrations [ Time Frame: 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).

  3. Change in 2-Back task [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Structured Clinical Interview for DSM (SCID-I/P; First et al., 1995) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.

  2. Change in Addiction Severity Index (ASI) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The ASI will be used to carefully examine alcohol and drug abuse frequency and severity

  3. Change in Alcohol Use Disorders Identification Test (AUDIT; Barbor, et al., 2001) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The AUDIT is a ten-item measure developed by the World Health Organization to assess alcohol use and alcohol-related consequences.

  4. Change in Michigan Alcohol Screening Test (MAST; Selzer, 1971) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The MAST is a 25-item questionnaire which aims to screen for lifetime alcohol-related problems and alcoholism.

  5. Change in Fagerstrom Test for Nicotine Dependence and Heaviness of Smoking (FTQ; Heatherton et al., 1991) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The FTQ provides a brief self-report measure of nicotine dependence.

  6. Change in Yale Food Addiction Scale (YFAS; Gearhardt et al., 2009) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The YFAS purports to assess markers of substance dependence in relation to the consumption of high fat and high sugar foods.

  7. Change in Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.

  8. Change in UPPS-P Impulsive Behavior Scale (UPPS-P; Whiteside & Lynam, 2001) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.

  9. Change in Adult Temperament Questionnaire-Short Form (ATQ-SF; Evans & Rothbart, 2007) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.

  10. Change in Emotional Eating Scale (EES; Arnow, Kenardy, & Agras, 1995) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.

  11. Change in Eating Disorder Examination Overeating Section (EDE; Fairburn, 2008) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    The overeating section of the EDE will be used to assess overeating, binge eating, and loss of control eating in this sample.

  12. Change in SCID-I/P Impulse Control Module (First et al., 1995; Muller et al., 2009) [ Time Frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370732


Contacts
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Contact: Kathy Lancaster, BA 701-365-4945 klancaster@nrifargo.com

Locations
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United States, North Dakota
Neuropsychiatric Research Institute Recruiting
Fargo, North Dakota, United States, 58103
Contact: Ron Erickson    701-293-1335      
Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
University of Kentucky
Kent State University
North Dakota State University
Investigators
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Principal Investigator: Kristine Steffen, PharmD, PhD Neuropsychiatric Research Institute
Principal Investigator: Scott Engel, PhD Neuropsychiatric Research Institute

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Responsible Party: Kristine Steffen, Research Scientist, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT02370732    
Other Study ID Numbers: AA022336
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota:
Alcohol
Bariatric Surgery
Roux en Y Gastric bypass
Alcohol impairment
Alcohol reinforcement
Alcohol pharmacokinetics
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs