Effects of Acetate and Alcohol on Brain Function

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Cerebral Blood Flow; Brain Function

Treatments: Drug: acetate; Drug: alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT02542150

UL1TR001082 (U.S. NIH Grant/Contract)

15-0933

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

acetate arm

Experimental group

Description:

IV acetate given during magnetic resonance scan

Treatment:

Drug: acetate

alcohol arm

Experimental group

Description:

jello shots given before magnetic resonance scan

Treatment:

Drug: alcohol