Effects of Acetate and Alcohol on Brain Function

June 2, 2021 updated by: University of Colorado, Denver
This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study plans to learn more about how alcohol and its metabolite, acetate, affect brain function.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria-all:

  1. Subjects who are age 21-55,
  2. Subjects who are proficient in English ,
  3. Subjects who understand the nature of the study,
  4. Subjects who have signed an informed consent,
  5. Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),

Inclusion Criteria-moderate drinkers:

  1. Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).
  2. Subjects who have drunk at least 2 drinks in one hour in the past, and have no history of dependence on drugs or alcohol

Inclusions-AUD:

(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)

Exclusion Criteria-all:

  1. Subjects who have a "facial flushing" response to alcohol,
  2. Subjects who are pregnant or nursing,
  3. Subjects who have major medical problems including diabetes, high blood pressure (> 150/90), prior neurological or psychiatric history (schizophrenia, bipolar, or current major depressive disorder), epilepsy (alcohol withdrawal seizures is not an exclusion),
  4. Subjects who have been told they have or been diagnosed with liver or kidney disease,
  5. Subjects who have chronic gastrointestinal disease,
  6. Subjects who are obese (BMI>30 kg/m2),
  7. Subjects who take psychoactive medications,
  8. Subjects who have prior head trauma resulting in loss of consciousness >15 minutes,
  9. Subjects who have Magnetic Resonance (MR) exclusions which include claustrophobia, intracranial, orbital, or spinal metal implants, pacemakers, cochlear implants, cardiac stents or other non-MR-compatible implants or devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetate arm
IV acetate given during magnetic resonance scan
Drug: acetate
acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
Other Names:
  • ethanoate
Experimental: alcohol arm
jello shots given before magnetic resonance scan
Drug: alcohol
a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.
Other Names:
  • ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
Time Frame: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.
cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.
fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Jody L Tanabe, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0933
  • UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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