Effects of Acetate and Alcohol on Brain Function

Cerebral Blood Flow Clinical Trial

Official title:

Effects of Acetate and Alcohol on Brain Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542150
• Other study ID #: 15-0933
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Function
• Cerebral Blood Flow

Intervention

Drug:
• acetate
acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
• alcohol
a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling	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.