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NCT04299373 · ClinicalTrials.gov registry record · Early Phase 1
Surgical Weight Loss and Alcohol Perception
A Early Phase 1 study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT04299373 is a Early Phase 1 study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 3 participants.
The verdict
NCT04299373, a Early Phase 1 study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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 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 sens
Interventions
- DRUG Alcohol: Oral administration
- DRUG Alcohol: Intravenous administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2022-09-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04299373
The ClinicalTrials.gov registry entry for NCT04299373 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alcohol: Oral administration is the first listed.
NCT04299373 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04299373 about?
NCT04299373 is a clinical study titled "Surgical Weight Loss and Alcohol Perception". 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 mo...
What is the current status of trial NCT04299373?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2020-02-10. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT04299373?
The interventions under investigation include: Alcohol: Oral administration (DRUG), Alcohol: Intravenous administration (DRUG).
Who is sponsoring clinical trial NCT04299373?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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