Brain Function, Cerebral Blood Flow
Conditions
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.
Interventions
DRUGacetate
acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
DRUGalcohol
a jello shot containing alcohol, a jello shot containing no alcohol, fMRI scan.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Dates: January 2016-March 2017 Target population: Healthy controls Method: Advertisements, flyers, word of mouth
Participants by arm
| Arm | Count |
|---|---|
| Acetate Arm 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 | 12 |
| Alcohol Arm 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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Alcohol Arm | Total | Acetate Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 24 Participants | 12 Participants |
| Age, Continuous | 31.1 years STANDARD_DEVIATION 3.9 | 28.5 years STANDARD_DEVIATION 3.1 | 27.8 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
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.
Time frame: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetate Arm | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Right Thalamus | 31.7 cc/100 mg/min | Standard Deviation 5.6 |
| Acetate Arm | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Left Thalamus | 32.8 cc/100 mg/min | Standard Deviation 6.8 |
| IV Placebo (Acetate Arm) | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Left Thalamus | 27.3 cc/100 mg/min | Standard Deviation 5.6 |
| IV Placebo (Acetate Arm) | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Right Thalamus | 26.9 cc/100 mg/min | Standard Deviation 5.7 |
| Alcohol Arm | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Right Thalamus | 30.0 cc/100 mg/min | Standard Deviation 9.7 |
| Alcohol Arm | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Left Thalamus | 29.9 cc/100 mg/min | Standard Deviation 8.9 |
| Oral Placebo (Alcohol Arm) | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Right Thalamus | 25.0 cc/100 mg/min | Standard Deviation 7.5 |
| Oral Placebo (Alcohol Arm) | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | Left Thalamus | 24.9 cc/100 mg/min | Standard Deviation 6.7 |