Effects of Acetate and Alcohol on Brain Function

NCT ID: NCT02542150

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

Brief Summary

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

Detailed Description

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

Conditions

Cerebral Blood Flow; Brain Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

acetate arm

IV acetate given during magnetic resonance scan

Group Type: EXPERIMENTAL

acetate

Intervention Type: DRUG

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

alcohol arm

jello shots given before magnetic resonance scan

Group Type: EXPERIMENTAL

alcohol

Intervention Type: DRUG

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

Interventions

acetate

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

Intervention Type: DRUG

alcohol

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

Intervention Type: DRUG

Other Intervention Names

ethanoate; ethanol

Eligibility Criteria

Inclusion Criteria

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),

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

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jody L Tanabe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Aurora, Colorado, United States

Countries

United States

References

Tanabe J, Yamamoto DJ, Sutton B, Brown MS, Hoffman PL, Burnham EL, Glueck DH, Tabakoff B. Effects of Alcohol and Acetate on Cerebral Blood Flow: A Pilot Study. Alcohol Clin Exp Res. 2019 Oct;43(10):2070-2078. doi: 10.1111/acer.14173. Epub 2019 Aug 24.

Reference Type: RESULT

PMID: 31386214 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-0933

Identifier Type: -

Identifier Source: org_study_id