Effects of Acetate and Alcohol on Brain Function

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT02542150
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Blood Flow; Brain Function	Drug: acetate; Drug: alcohol	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Acetate and Alcohol on Brain Function
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 31, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acetate arm IV acetate given during magnetic resonance scan	Drug: acetate; acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan; Other Names: ethanoate
Experimental: alcohol arm jello shots given before magnetic resonance scan	Drug: alcohol; a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.; Other Names: ethanol

Outcome Measures

Primary Outcome Measures

1. Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Jody L Tanabe, MD, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 22, 2017

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02542150
• Other Study ID Numbers: 15-0933; UL1TR001082
• First Posted: Sep 4, 2015
• Last Update Posted: Jun 25, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Ethanol

Study Results

Participant Flow

Recruitment Details	Dates: January 2016-March 2017 Target population: Healthy controls Method: Advertisements, flyers, word of mouth

Arm/Group Title	Acetate Arm	Alcohol Arm
Arm/Group Description	Placebo for 1 hour, then Acetate for 1 hour IV acetate given during magnetic resonance scan. acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan	Placebo for 1 hour, then Alcohol (given as a single dose of jello). jello given before magnetic resonance scan alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.
Period Title: Overall Study
STARTED	12	12
Completed Placebo	12	12
Started Intervention	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Acetate Arm	Alcohol Arm	Total
Arm/Group Description	Placebo for 1 hour, then Acetate for 1 hour. IV acetate given during magnetic resonance scan acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan	Placebo for 1 hour, then alcohol (given as a single dose with jello). jello given before magnetic resonance scan alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.8 (4.2)	31.1 (3.9)	28.5 (3.1)
Sex: Female, Male (Count of Participants)
Female	10 83.3%	8 66.7%	18 75%
Male	2 16.7%	4 33.3%	6 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 100%	12 100%	24 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
Description	cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.
Time Frame	fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetate Arm	IV Placebo (Acetate Arm)	Alcohol Arm	Oral Placebo (Alcohol Arm)
Arm/Group Description	IV acetate given during magnetic resonance scan acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan	Placebo given before Acetate.	jello shots given before magnetic resonance scan alcohol: a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.	Placebo given before Alcohol.
Measure Participants	12	12	12	12
Right Thalamus	31.7 (5.6)	26.9 (5.7)	30.0 (9.7)	25.0 (7.5)
Left Thalamus	32.8 (6.8)	27.3 (5.6)	29.9 (8.9)	24.9 (6.7)

Adverse Events

Time Frame	1 Day
Arm/Group Title	Acetate Arm		IV Placebo (Acetate Arm)		Alcohol Arm		Oral Placebo (Alcohol Arm)
Arm/Group Description	IV acetate given during magnetic resonance scan acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan		Placebo given before Acetate.		jello given before magnetic resonance scan alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.		Placebo given before Alcohol.
All Cause Mortality
	Acetate Arm		IV Placebo (Acetate Arm)		Alcohol Arm		Oral Placebo (Alcohol Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Acetate Arm		IV Placebo (Acetate Arm)		Alcohol Arm		Oral Placebo (Alcohol Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Acetate Arm		IV Placebo (Acetate Arm)		Alcohol Arm		Oral Placebo (Alcohol Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Immune system disorders
Allergic reaction	1/12 (8.3%)	1	0/12 (0%)	0	0/12 (0%)	0	0/12 (0%)	0

Limitations/Caveats

Data collection for an outcome measure related to brain activity during decision making before and after receiving alcohol or acetate was never completed due to feasibility and funding limitations and challenges encountered during the study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.