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TerminatedNCT01492933Updated Dec 3, 2019

Measuring Effects of Alcohol on Brain Chemistry

An observational study in Healthy Volunteers, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Terminated at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
34
Ages
21 Years to 45 Years
Sex
All
01

Study summary

Background:

- Studies show that alcohol changes the amount of many brain chemicals. These changes may be related to continued drinking, craving for alcohol, and relapse. This study will use magnetic resonance imaging (MRI) to look at brain areas and brain chemistry during an infusion of alcohol. It will also study how changes in brain chemistry relate to participant reports of feeling drunk.

Objectives:

- To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry

Eligibility:

  • Individuals between 21 and 45 years of age.
  • Participants will be either light drinkers (1 to 14 standard alcoholic drinks per week) or heavy drinkers (20 to 40 standard alcoholic drinks per week). A standard drink is a 12-ounce beer, a 4-ounce glass of wine, or a shot of liquor.
  • Participants must be able to go without alcohol for at least 3 days in a row without severe withdrawal symptoms.

Design:

  • This study requires two or three outpatient visits to the NIH Clinical Center.
  • Participants will have a physical exam and medical history. Blood and urine samples will be collected. Participants' alcohol drinking habits will also be assessed to determine whether they may have an alcohol use disorder.
  • At the first study visit, participants will have an infusion of alcohol. Blood samples will be collected to measure blood alcohol levels.
  • The MRI study visit will take place about 3 days after the first study visit. Participants will have an MRI scan of the brain, followed by an infusion of alcohol and another scan. Blood samples will be collected.
  • Participants will complete questionnaires before and after each infusion to measure their response to alcohol.
  • Heavy drinkers will come to the clinic for a third visit to discuss possible future treatment and any risky behavior associated with their high levels of alcohol use.
Read the detailed description

Rodent studies have indicated that modulation of glutamatergic transmission contributes to alcohol intoxication, reinforcement, tolerance, and dependence. Brain microdialysis studies have in general shown that acute alcohol suppresses glutamate release, while alcohol withdrawal leads to progressively increased extracellular levels.

Here, we will use an acute, pharmacokinetically controlled alcohol challenge and magnetic resonance spectroscopy (MRS) to study the relationship between brain alcohol and glutamate concentrations, and correlate these with subjective feelings of alcohol effects, as measured by the Drug Effects Questionnaire (DEQ) in human subjects. Correlations between MRS data and other behavioral data from the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Alcohol Sensitivity Questionnaire (ASQ), and the Alcohol Effects Questionnaire (AEFQ) will be investigated.

Healthy participants aged 21-45, without gross impairment of judgment or complicated psychiatric or other morbidity, will receive a preliminary infusion to ensure no adverse effects from intravenous (IV) alcohol administration to a target BAC of 0.08g/dl. In a subsequent session, participants will be infused with alcohol to the same target level while being scanned in the MR scanner and reporting subjective feelings using the DEQ. Two groups of subjects will be recruited: heavy drinkers, classified as females who consume 15 plus drinks per week and males who consume 20 plus drinks per weekthose who consume between 20 and 40 drinks per week, and light drinkers, classified as females who consume between 1 and 10 drinks per week and males who consume between 1 and 14 drinks per week. those who consume between 1 and 14 drinks per week.

Central glutamate levels will be quantified at 3T using pharmacologically validated MRS methodology recently published from our laboratory, and its relationship to central alcohol levels will be determined. Relationships will also be analyzed between DEQ scores and brain glutamate and alcohol levels. Finally, it will be examined whether drinking history (i.e. being a light versus heavy drinker) is a moderator of any of these relationships.

02

Conditions studied

  • Healthy Volunteers

Browse trials for

Keywords

  • Ethanol
  • Magnetic Resonance Spectroscopy
  • Spectroscopy
  • Alcohol Use
03

In context

Alcohol Drinking

940 studies on the registry are indexed under Alcohol Drinking; 169 are open to participants now.

This study's enrollment of 34 is below the median of 218 across 93 observational studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 15 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.

Browse National Institute on Alcohol Abuse and Alcoholism (NIAAA) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  • INCLUSION CRITERIA (Light Drinkers)

    1. In good health as determined by medical history, physical exam, ECG and lab tests;
    2. Between 21 and 45 years of age;
    3. Currently consuming between 1 and 10 drinks per week for females and 1 and 14 drinks per week for males.

EXCLUSION CRITERIA (Light Drinkers)

  1. Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dL.
  2. Have fulfilled DSM-IV criteria for a current or past major psychiatric disorder including alcohol or other substance dependnece (excluding nicotine);
  3. Have a Body Mass Index (BMI) value over 35;
  4. Unable to stop taking any prescribed, non-prescribed, or over-the-counter medication or drugs 3 days prior to study days (excluding oral contraceptive agents). If a subject is taking a prescribed medication (excluding oral contraceptive agents) that is not take-as-needed they will be excluded from participation;
  5. Are pregnant, as determined by a negative pregnancy test, or lactating;
  6. Report to have a "facial flushing" response to the consumption of alcohol;
  7. Have never consumed at least two standard drinks of alcohol within one hour;
  8. Have ferromagnetic objects in their bodies, which might be adversely affected by MRI including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal works may have any doubt about presence of these objects will result in exclusion from this study);
  9. Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal symptoms. Occasional (not daily) use of tobacco products is acceptable;
  10. Unwilling to abstain from alcohol for at least 2 days prior to the studies.

INCLUSION CRITERIA (Heavy Drinkers)

  1. In good health as determined by medical history, physical exam, ECG and lab tests;
  2. Between 21 and 45 years of age;
  3. Currently consuming 15+ drinks for females and 20+ drinks for males;
  4. Not regularly abstinent for more than 3 days per week, but have abstained from alcohol for 3 consecutive days without experiencing withdrawal symptoms;
  5. Able to provide a plausible history that they can abstain from alcohol without significant withdrawal symptoms when coming to the clinic. In addition, participants will be asked to quantify their worst withdrawal symptoms using the Clinical Institute Withdrawal Assessment (CIWA) Instrument. Participants who score 8 or above will not be enrolled in the protocol;
  6. Not seeking treatment for their alcohol consumption.

EXCLUSION CRITERIA (Heavy Drinkers)

  1. Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dL.
  2. Have fulfilled DSM-IV criteria for a current or past major psychiatric disorder, including any substance dependence (excluding alcohol or nicotine) at any time;
  3. Have a Body Mass Index (BMI) value over 35;
  4. Unable to stop taking any prescribed, non-prescribed, or over-the-counter medication or drugs 3 days prior to study days (excluding oral contraceptive agents). If a subject is taking a prescribed medication (excluding oral contraceptive agents) that is not take-as-needed they will be excluded from participation;
  5. Are pregnant, as determined by a negative pregnancy test, or lactating;
  6. Report to have a "facial flushing" response to the consumption of alcohol;
  7. Have never consumed at least two standard drinks of alcohol within one hour;
  8. Have ferromagnetic objects in their bodies, which might be adversely affected by MRI including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal works may have any doubt about presence of these objects will result in exclusion from this study);
  9. Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal symptoms. Occasional (not daily) use of tobacco products is acceptable;
  10. Unwilling to abstain from alcohol for at least 2 days prior to the studies.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
34 participants (actual)
06

What researchers measure

Primary outcomes

  1. What is the correlation between measured blood and breath alcohol level and ethanol level concentration computed from MRS.

    Time frame: End of study

Secondary outcomes

  1. Does ethanol administration similarly affect the metabolite activities in all the regions of the brain Gray and White matter?

    Time frame: End of study

  2. Measure: Does ethanol metabolite concentration correlate with any of subjective effects of ethanol as measured by response to DEQ questions?

    Time frame: End of study

07

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Beckmann CF, Smith SM. Tensorial extensions of independent component analysis for multisubject FMRI analysis. Neuroimage. 2005 Mar;25(1):294-311. doi: 10.1016/j.neuroimage.2004.10.043. Epub 2005 Jan 8. PubMed 15734364 ↗
  • Romanos GE, Schroter-Kermani C, Bernimoulin JP. [Collagen as a basic element of the periodontium: immunohistochemical aspects in the human and animals. 2. Cementum and periodontal ligament]. Parodontol. 1991 Feb;2(1):47-59. German. PubMed 1854918 ↗
  • Behrens TE, Berg HJ, Jbabdi S, Rushworth MF, Woolrich MW. Probabilistic diffusion tractography with multiple fibre orientations: What can we gain? Neuroimage. 2007 Jan 1;34(1):144-55. doi: 10.1016/j.neuroimage.2006.09.018. Epub 2006 Oct 27. PubMed 17070705 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01492933
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted
Dec 15, 2011
Start date
Nov 22, 2011
Completion
Feb 24, 2015
Last update
Dec 3, 2019

Study contacts

Reza Momenan, Ph.D.
principal investigator · National Institute on Alcohol Abuse and Alcoholism (NIAAA)
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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