Alcohol Related Impairment and Reinforcement: Pre to Post Roux en Y Gastric Bypass Surgery
Status unconfirmed · Not applicable
Conditions studied: Bariatric Surgery Candidate
In brief
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.
Key facts
- Study ID
- NCT02370732
- Run by
- Neuropsychiatric Research Institute, Fargo, North Dakota
- People needed
- 60
- Starts
- 2015-02-01
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2016-09-28
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female (approximately 50% each)
- 21 - 65 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
- Smoking defined as regular use of nicotine in the past 6 months
- A presurgery weight of > 400lbs at screening appointment or as reported on telephone screen
- 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.
- 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.
Where it is running
- Neuropsychiatric Research Institute — Fargo, North Dakota, United States (enrolling)
Full record on ClinicalTrials.gov
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