Cerebral Blood FlowNCT02542150

Effects of Acetate and Alcohol on Brain Function

A study testing acetate and alcohol in people with Cerebral Blood Flow and Brain Function, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cerebral Blood Flow, Brain Function
What is being tested?: acetate and alcohol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 31 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Show all 9Show fewer

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

Who cannot join

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),

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Aurora, Colorado, 80045

Other trials in United States

About this study

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

Read the detailed description

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

Conditions: Cerebral Blood Flow, Brain Function
Being tested: acetate, alcohol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acetateDrug
Also called ethanoate
acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
alcoholDrug
Also called ethanol
a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.

Study groups in NCT02542150
Study group	Role	What they receive
acetate arm	Experimental	IV acetate given during magnetic resonance scan Receives: Drug: acetate
alcohol arm	Experimental	jello shots given before magnetic resonance scan Receives: Drug: alcohol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201531 Mar 2017

First posted4 Sep 2015 (estimated)
Study startSep 2015
Primary completion31 Mar 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cerebral Blood FlowStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02542150
Sponsor's protocol ID: 15-0933
Other IDs: UL1TR001082
Status last verified: Jun 2021
First submitted: 1 Sep 2015
Last updated: 25 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 31386214

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events
Acute Ischemic Stroke, Large Vessel Occlusion
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
At Risk for AD-dementia, With Subjective Cognitive Decline, At Risk for Cognitive Decline
RecruitingPhase 3
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
Ischemic Stroke

All Cerebral Blood Flow trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Acetate and Alcohol on Brain Function
ClinicalTrials.gov ID: NCT02542150
Acronym / sponsor ID: 15-0933
Conditions: Cerebral Blood Flow, Brain Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Sep 2015
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Posted 25 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
acetate arm	Experimental	Drug: acetateIV acetate given during magnetic resonance scan
alcohol arm	Experimental	Drug: alcoholjello shots given before magnetic resonance scan

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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),

Key exclusion criteria (9 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acetateAlso: ethanoateacetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan	Drug	acetate arm
alcoholAlso: ethanola "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.	Drug	alcohol arm

Primary outcome

Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
Time frame: 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.

Results and safety

Results posted to the registry on 25 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetate Arm	12	12
Alcohol Arm	12	12

Primary outcome: Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling

Time frame: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.. Mean (Standard Deviation). Unit: cc/100 mg/min

Measure	Acetate Arm n = 12	IV Placebo (Acetate Arm) n = 12	Alcohol Arm n = 12	Oral Placebo (Alcohol Arm) n = 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetate Arm	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
IV Placebo (Acetate Arm)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Alcohol Arm	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Oral Placebo (Alcohol Arm)	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31386214Tanabe 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.
Individual participant dataSharing planned: No

Related trials for Cerebral Blood Flow

RecruitingPhase 3
Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events
Acute Ischemic Stroke, Large Vessel Occlusion
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
At Risk for AD-dementia, With Subjective Cognitive Decline, At Risk for Cognitive Decline
RecruitingPhase 3
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jody L Tanabe, MD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing acetate and alcohol in people with Cerebral Blood Flow and Brain Function, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling (time frame: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.