Status:
TERMINATED
Surgical Weight Loss and Alcohol Perception
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
University of Illinois at Urbana-Champaign
Conditions:
Bariatric Surgery Candidate
Eligibility:
FEMALE
30-55 years
Phase:
EARLY_PHASE1
Brief Summary
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 la...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04299373
Start Date
February 10 2020
End Date
September 9 2022
Last Update
February 2 2024
Active Locations (1)
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1
University of Missouri Hospital
Columbia, Missouri, United States, 65211