Healthy VolunteersNCT01492933
Measuring Effects of Alcohol on Brain Chemistry
An observational study of Healthy Volunteers, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2011to 24 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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;
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- 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.
Who cannot join
- 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;
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- Have never consumed at least two standard drinks of alcohol within one hour;
- 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);
- 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.
- 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 any substance dependence (excluding alcohol or nicotine) at any time;
- 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;
- 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);
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Measuring Effects of Acute Ethanol on Human Brain Metabolites Using Magnetic Resonance Spectroscopy
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Keywords
- Ethanol, Magnetic Resonance Spectroscopy, Spectroscopy, Alcohol Use
- Medical subject headings
- Alcohol Drinking
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the correlation between measured blood and breath alcohol level and ethanol level concentration computed from MRS.
Measured: 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?
Measured: End of study
Measure: Does ethanol metabolite concentration correlate with any of subjective effects of ethanol as measured by response to DEQ questions?
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study start22 Nov 2011
- Study completion24 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Reza Momenan, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492933
- Sponsor's protocol ID
- 120032
- Other IDs
- 12-AA-0032
- Status last verified
- 24 Feb 2015
- First submitted
- 14 Dec 2011
- Last updated
- 3 Dec 2019
- Results posted
- No
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 15734364Romanos 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 1854918Behrens 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Effects of Acute Ethanol on Human Brain Metabolites Using Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT01492933
- Acronym / sponsor ID
- 120032
- Conditions
- Healthy Volunteers
- Keywords
- Ethanol, Magnetic Resonance Spectroscopy, Spectroscopy, Alcohol Use
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 22 Nov 2011
- Study completion
- 24 Feb 2015
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
What is the correlation between measured blood and breath alcohol level and ethanol level concentration computed from MRS.
Time frame: End of study
2 secondary outcomes
Does ethanol administration similarly affect the metabolite activities in all the regions of the brain Gray and White matter?
Time frame: End of study
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 15734364Beckmann 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.
- Background: PubMed 1854918Romanos 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.
- Background: PubMed 17070705Behrens 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.
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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.
Reza Momenan, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 20 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: stopped early, as of the sponsor's last update on 3 Dec 2019. 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?
The study was stopped early. Results are not available in the source record.
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?
What is the correlation between measured blood and breath alcohol level and ethanol level concentration computed from MRS. (time frame: End of study). 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 NCT01492933, which also lists 3 linked publications.
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 3 Dec 2019.