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

NCT02370732 | Unknown

• 1 other identifier: AA022336
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

Alcohol; Bariatric Surgery; Roux en Y Gastric bypass; Alcohol impairment; Alcohol reinforcement; Alcohol pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Change in 2-Back task

  Pre-surgery (up to 3 months before surgery) and 1 year post surgery

Other Outcomes (12)

• Change in Structured Clinical Interview for DSM (SCID-I/P; First et al., 1995)

  Pre-surgery (up to 3 months before surgery) and 1 year post surgery

• Change in Addiction Severity Index (ASI)

  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)

  Pre-surgery (up to 3 months before surgery) and 1 year post surgery

Study Arms (1)

Roux en Y Gastric Bypass

OTHER

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

Interventions

Alcohol OTHER

A weight based dose of alcohol will be administered during each study day.

Roux en Y Gastric Bypass

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (approximately 50% each)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• University of Kentucky: collaborator
• Kent State University: collaborator
• North Dakota State University: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Kristine Steffen, PharmD, PhD

  Neuropsychiatric Research Institute

  PRINCIPAL INVESTIGATOR

• Scott Engel, PhD

  Neuropsychiatric Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Lancaster, BA

CONTACT

701-365-4945; klancaster@nrifargo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)