Bariatric Surgery CandidateNCT02370732
Alcohol Related Impairment and Reinforcement: Pre to Post Roux en Y Gastric Bypass Surgery
A study testing Alcohol in people with Bariatric Surgery Candidate, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103
Ron Erickson, 701-293-1335
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Alcohol
- Keywords
- Alcohol, Bariatric Surgery, Roux en Y Gastric bypass, Alcohol impairment, Alcohol reinforcement, Alcohol pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
A weight based dose of alcohol will be administered during each study day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Secondary outcomes (3)
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".
Measured: 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).
Measured: 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.
Measured: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Kent State University, North Dakota State University
- Responsible party
- Principal investigator, Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota
- Investigators
- Kristine Steffen, PharmD, PhD, Principal investigator, Neuropsychiatric Research InstituteScott Engel, PhD, Principal investigator, Neuropsychiatric Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370732
- Sponsor's protocol ID
- AA022336
- Status last verified
- Sep 2016
- First submitted
- 12 Feb 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Related Impairment and Reinforcement After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02370732
- Acronym / sponsor ID
- AA022336
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Alcohol, Bariatric Surgery, Roux en Y Gastric bypass, Alcohol impairment, Alcohol reinforcement, Alcohol pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
- Collaborators
- University of Kentucky, Kent State University, North Dakota State University
- Study start
- Feb 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roux en Y Gastric Bypass | Other | Other: AlcoholParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholA weight based dose of alcohol will be administered during each study day. | Other | Roux en Y Gastric Bypass |
Primary outcome
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.
3 secondary outcomes
Change in Desire-for-Drug Scale
Time frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in pharmacokinetics as measured via blood alcohol concentrations
Time frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Change in 2-Back task
Time frame: Pre-surgery (up to 3 months before surgery) and 1 year post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Steffen, PharmD, PhD principal investigator
Neuropsychiatric Research Institute
Scott Engel, PhD principal investigator
Neuropsychiatric Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Bariatric Surgery Candidate, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathy Lancaster, BA (701-365-4945, klancaster@nrifargo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.