Columbia, Missouri 65211

  • Bariatric Surgery Candidate

Purpose:

The study will involve administration of alcohol in a controlled laboratory setting to individuals who are scheduled for Roux-en-Y gastric bypass surgery, and then asking them to return for another laboratory session 3 months following their surgery. A small number will be asked to return again 9 months following their surgery. The primary objective for this research is to collect pilot data on the effects of metabolic surgery (MS), also known as bariatric surgery, on the metabolism of alcohol. These data will be used as preliminary evidence in support of a subsequent application for funding, to be submitted to the National Institutes of Health. A secondary objective for this research is to determine the extent to which MS changes reactivity to alcohol-related cues. Heightened reactivity (e.g., attention bias; craving) to alcohol-related cues is known to signify increased risk for heavy drinking and AUD. No research to date has examined whether the increased sensitivity to alcohol that occurs as a result of MS changes cue-reactivity responses, which in theory reflect an individual's history of learning to associate alcohol consumption with its subjective effects. An exploratory objective is to compare metabolism of alcohol administered orally versus intravenously. IV infusion of alcohol bypasses so-called "first pass metabolism" of alcohol after absorption by the gastrointestinal tract. Thus, compared to oral ingestion, infusion can achieve the same blood alcohol concentration (BAC) with substantially less total alcohol dosage. Following the hypothesis, this should mean that, compared to oral ingestion, infusion will be associated with less production of liver fat, while also mimicking in pre-surgery patients what the investigators observe with oral ingestion following surgery. This comparison will permit better specification of when (during metabolism) and how alcohol is converted to liver fat, and will allow the investigators to separate effects of initial sensitivity to alcohol (a person's subjective response to the initial introduction of alcohol into the body) from effects associated with tolerance (i.e., the body's attempts to re-establish homeostasis after alcohol is introduced).


Criteria:

Inclusion Criteria: - Obese, with body weight less than 450 lbs - non-smoking female volunteers of any race - age 30-55 years - drink alcohol in moderation and meet all of the BSC's indications and criteria for RYGB surgery. NIH/NIAAA criteria specify an average of between 3 and 7 standard drinks per week as moderate alcohol drinking (for women). In addition, included participants must fall within the upper or lower tercile of scores on the ASQ for a bariatric population, as determined by the investigator's previous studies with this population.9,10,19 Exclusion Criteria: - their AUDIT scores (16 or above) indicate the possibility of a current or prior alcohol use disorder. - they report typically drinking less than once per month and consuming less than 3-4 drinks per occasion. - they are taking prescribed psychoactive medications, other than selective serotonin reuptake inhibitors (SSRIs) for anxiety/depression. - they are taking medications that might interfere with alcohol metabolism (e.g., anti-histamine h2 receptor antagonists [mainly, antacids used to treat GERD and gastro-intestinal ulcers], certain antibiotics such as erythromycin, or other drugs influencing hepatic cytochrome P450 2E1; see medicine.iupui.edu/clinpharm/ddis/table.aspx). - their medical records indicate current anemia. - their FTND scores indicate moderate or greater nicotine dependence (4 or above). - they report they are trying to become pregnant, or produce a positive urine screen for pregnancy at the lab session. - their body weight is > 450 lbs. - they have participated in any other research study or medical procedure involving ionizing radiation exposure greater than a chest X-ray in the past 12 months. - they live more than 60 miles from the CRC.


Study is Available At:


Original ID:

2016390


NCT ID:

NCT04299373


Secondary ID:


Study Acronym:

SWAP


Brief Title:

Surgical Weight Loss and Alcohol Perception


Official Title:

Effects of Metabolic Surgery on Alcohol Pharmacokinetics


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

30 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bruce D Bartholow, Ph.D.
Principal Investigator
University of Missouri-Columbia
Primary Contact:Bruce D Bartholow, Ph.D.
573-882-1805
bartholowb@missouri.edu
Backup Contact:Elizabeth J Parks, Ph.D.
573-882-5864
parksej@missouri.edu

Study Dates

Start Date:February 10, 2020
Completion Date:December 1, 2021
Completion Type:Anticipated
Primary Completion Date:September 1, 2021
Primary Completion Type:Anticipated
Verification Date:December 2020
Last Changed Date:December 14, 2020
First Received Date:February 12, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reactivity to alcohol cues: motivational approach bias
Time Frame:Assessed prior to acute alcohol exposure, approximately 10 minutes
Safety Issues:False
Description:The tendency to approach alcohol-related cues will be assessed using a laboratory task known as the Alcohol Approach-Avoidance Task. In this task, images of alcoholic beverages, nonalcoholic beverages, and non-consumable liquids (e.g., motor oil) are pres
Outcome Type:Primary Outcome
Measure:Alcohol Sensitivity Questionnaire
Time Frame:Pre-surgery and 3 months after surgery
Safety Issues:False
Description:Individual differences in self-reported sensitivity to alcohol's effects will be assessed using the Alcohol Sensitivity Questionnaire. This measure contains 15 items, each describing an effect people typically experience when drinking alcohol (e.g., feeli
Outcome Type:Primary Outcome
Measure:Alcohol Urge Questionnaire
Time Frame:Assessed prior to acute alcohol exposure, approximately 10 minutes
Safety Issues:False
Description:Cue-induced craving for alcohol will be assessed using a beverage presentation procedure. Participants complete a self-report measure of craving, the Alcohol Urge Questionnaire. Participants then are presented with a glass containing an alcoholic beverage
Outcome Type:Primary Outcome
Measure:Subjective Effects of Alcohol Scale
Time Frame:Multiple intervals following alcohol administration, up to 4 hours post-exposure
Safety Issues:False
Description:Participants' self-reported feelings of stimulation, sedation, and intoxication following exposure to a controlled dose of alcohol in the lab will be assessed using the Subjective Effects of Alcohol Scale (Morean, Corbin, & Treat, 2013). Possible scor

Study Interventions

Intervention Type:Drug
Name:Alcohol: Intravenous administration
Description:Patients who plan to undergo bariatric surgery will be infused with alcohol intravenously.
Arm Name:Alcohol: Intravenous administration
Intervention Type:Drug
Name:Alcohol: Oral administration
Description:Patients who plan to undergo bariatric surgery will consume a controlled dose of alcohol orally.
Arm Name:Alcohol: Oral administration

Study Arms

Study Arm Type:Experimental
Arm Name:Alcohol: Intravenous administration
Description:Participants in this arm will be infused intravenously with a dose of alcohol sufficient to raise their breath alcohol concentration to .065% within 20 minutes.
Study Arm Type:Experimental
Arm Name:Alcohol: Oral administration
Description:Participants in this arm will consume a measured dose of alcohol orally, with the goal of achieving a target peak breath alcohol concentration of .065% within 20 minutes.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Illinois at Urbana-Champaign

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.