Surgical Weight Loss and Alcohol Perception

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 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).

Conditions

• Bariatric Surgery Candidate

Interventions

DRUG

Alcohol: Oral administration

Patients who plan to undergo bariatric surgery will consume a controlled dose of alcohol orally.

DRUG

Alcohol: Intravenous administration

Patients who plan to undergo bariatric surgery will be infused with alcohol intravenously.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign

  collaborator OTHER

• University of Missouri-Columbia

  lead OTHER

Principal Investigators

• Bruce D Bartholow, Ph.D. · University of Missouri-Columbia

• Elizabeth J Parks, Ph.D. · University of Missouri-Columbia

• Andrew Wheeler, M.D. · University of Missouri-Columbia

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-10

Primary Completion

2022-09-09

Completion

2022-09-09

FDA Drug

Yes

Countries

• United States

Study Locations