NCT02542150

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

September 1, 2015

Results QC Date

June 2, 2021

Last Update Submit

June 2, 2021

Conditions

Cerebral Blood FlowBrain Function

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

acetate arm

EXPERIMENTAL

IV acetate given during magnetic resonance scan

Drug: acetate

alcohol arm

EXPERIMENTAL

jello shots given before magnetic resonance scan

Drug: alcohol

Interventions

acetateDRUG

acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan

Also known as: ethanoate
acetate arm
alcoholDRUG

a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.

Also known as: ethanol
alcohol arm

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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),
  • 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
  • (1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)

You may not qualify if:

  • Subjects who have a "facial flushing" response to alcohol,
  • Subjects who are pregnant or nursing,
  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Related 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.

    PMID: 31386214RESULT

MeSH Terms

Interventions

AcetatesEthanol

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsAlcohols

Limitations and 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.

Results Point of Contact

Title
Jody Tanabe, MD
Organization
University of Colorado Denver | Anschutz
clinicalresearchsupportcenter@ucdenver.edu
3037241111

Study Officials

  • Jody L Tanabe, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 4, 2015

Study Start

September 1, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

June 25, 2021

Results First Posted

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)