Aurora, Colorado, 80045, United States
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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Conditions
Age range
21 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
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
Drugacetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
Other names: ethanoate
Alcohol
Druga "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.
Other names: ethanol
Primary outcomes
-
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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