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OpenTrials
Completed

NCT Number: NCT02542150

Effects of Acetate and Alcohol on Brain Function

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

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aurora, Colorado, 80045, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-all:

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

Inclusion criteria

-moderate drinkers:

  • Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).
  • 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:

  • Subjects who have a "facial flushing" response to alcohol,
  • Subjects who are pregnant or nursing,
  • 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),
  • Subjects who have been told they have or been diagnosed with liver or kidney disease,
  • Subjects who have chronic gastrointestinal disease,
  • Subjects who are obese (BMI>30 kg/m2),
  • Subjects who take psychoactive medications,
  • Subjects who have prior head trauma resulting in loss of consciousness >15 minutes,
  • 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.

Treatment and study plan

acetate

Drug

acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan

Other names: ethanoate

Alcohol

Drug

a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.

Other names: ethanol

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2015
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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