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N/A N=24 Randomized Single-blind Basic Science

Effects of Acetate and Alcohol on Brain Function

Cerebral Blood Flow · Brain Function

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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