Measuring Effects of Alcohol on Brain Chemistry

NCT01492933 | Terminated

• 2 other identifiers: 12003212-AA-0032
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Ethanol; Magnetic Resonance Spectroscopy; Spectroscopy; Alcohol Use

Outcome Measures

Primary Outcomes (1)

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

  End of study

Secondary Outcomes (2)

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

  End of study

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

  End of study

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Have fulfilled DSM-IV criteria for a current or past major psychiatric disorder including alcohol or other substance dependnece (excluding nicotine);
• Have a Body Mass Index (BMI) value over 35;
• 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;
• Are pregnant, as determined by a negative pregnancy test, or lactating;
• Report to have a "facial flushing" response to the consumption of alcohol;
• Have never consumed at least two standard drinks of alcohol within one hour;
• 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;
• Unwilling to abstain from alcohol for at least 2 days prior to the studies.
• In good health as determined by medical history, physical exam, ECG and lab tests;
• Between 21 and 45 years of age;
• Currently consuming 15+ drinks for females and 20+ drinks for males;
• Not regularly abstinent for more than 3 days per week, but have abstained from alcohol for 3 consecutive days without experiencing withdrawal symptoms;
• 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;
• Not seeking treatment for their alcohol consumption.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 15734364 BACKGROUND

• 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.

  PMID: 1854918 BACKGROUND

• 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.

  PMID: 17070705 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Reza Momenan, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 15, 2011
• Study Start: November 22, 2011
• Study Completion: February 24, 2015
• Last Updated: December 3, 2019

Record last verified: 2015-02-24

Locations

US (1)