Measuring Effects of Alcohol on Brain Chemistry
|First Submitted Date||December 14, 2011|
|First Posted Date||December 15, 2011|
|Last Update Posted Date||July 2, 2017|
|Start Date||November 22, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||What is the correlation between measured blood and breath alcohol level and ethanol level concentration computed from MRS. [ Time Frame: End of study ]|
|Original Primary Outcome Measures
|Change History||Complete list of historical versions of study NCT01492933 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures
||Does ethanol administration similarly affect the metabolite activities in all the regions of the brain Gray and White matter?|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Measuring Effects of Alcohol on Brain Chemistry|
|Official Title||Measuring Effects of Acute Ethanol on Human Brain Metabolites Using Magnetic Resonance Spectroscopy|
- 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.
- To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry
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
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||February 24, 2015|
|Primary Completion Date||Not Provided|
EXCLUSION CRITERIA (Light Drinkers)
INCLUSION CRITERIA (Heavy Drinkers)
EXCLUSION CRITERIA (Heavy Drinkers)
|Ages||21 Years to 45 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||120032
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 24, 2015|