Recruiting

Observational Study

Sponsor:

Neuropsychiatric Research Institute, Fargo, North Dakota

Code:

NCT02370732

Conditions

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Alcohol

Study Details

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

Study ID

NCT02370732

Start date

Feb, 2015

Status verified date

Sep, 2016

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

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.

Interventions

Alcohol

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Neuropsychiatric Research Institute

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Ron Erickson

701-293-1335

More Information

Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

Last update posted

Sep 28, 2016

Last verified

Sep, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuropsychiatric Research Institute, Fargo, North Dakota on 2016-09-28.