N/A
N=24
Effects of Acetate and Alcohol on Brain Function
Cerebral Blood Flow · Brain Function
Bottom Line
View on ClinicalTrials.gov: NCT02542150 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling — 31.7; 26.9; 30.0; 25.0 cc/100 mg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acetate (Drug); alcohol (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling |
31.7; 26.9; 30.0; 25.0; 32.8; 27.3 | — |
Summary
This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.
Eligibility Criteria
Inclusion Criteria-all:
- Subjects who are age 21-55,
- Subjects who are proficient in English ,
- Subjects who understand the nature of the study,
- Subjects who have signed an informed consent,
- Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),
Inclusion Criteria-moderate drinkers:
- Subjects who are moderate drinkers (male: 1-14 drinks per week; female: 1-7 drinks per week).
- 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:
- Subjects who have a "facial flushing" response to alcohol,
- Subjects who are pregnant or nursing,
- 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),
- Subjects who have been told they have or been diagnosed with liver or kidney disease,
- Subjects who have chronic gastrointestinal disease,
- Subjects who are obese (BMI>30 kg/m2),
- Subjects who take psychoactive medications,
- Subjects who have prior head trauma resulting in loss of consciousness >15 minutes,
- 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.
Data sourced from ClinicalTrials.gov (NCT02542150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.