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| ID | Type | Description | Link |
|---|---|---|---|
| R00AA025401 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to visual ethanol cues, followed by oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.
Results from the 2014 National Survey on Drug Use and Health show that 26% of adults in the US engaged in binge drinking in the past month (SAMHSA 2014). Why some people "mature out" of this behavior while others persist may be due to one's physiological response to binge drinking. No previous study has assessed whether disrupted cortisol and neural network responses to alcohol cues may drive the compulsive alcohol consumption seen in binge drinking individuals who do not yet have an AUD.
The investigator will recruit beer drinking, non-smoking men and women ages 21-45 (N=80, equal gender) who are either moderate drinkers or binge/heavy drinkers for two neuroimaging and neuroendocrine assessments to determine if their "real world" drinking behavior, in a prospective one month follow up, can be predicted based upon the cortisol and neural network responses to alcohol cues (with a placebo control, counter-balanced and randomized). Finally, the influence of genetic variation in the FK506-binding protein 5 (FKBP5) gene, which regulates cortisol activity, on the cortisol and neural network responses to alcohol cues will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Beverage Cues | Active Comparator | Participants will complete an MRI with alcohol beverage visual cues and oral alcohol session. |
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| Non-Alcoholic Beverage Cues | Placebo Comparator | Participants will complete an MRI with non-alcoholic beverage cues and oral alcohol session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous blood draw | Drug | In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Neural Blood Flow | Blood flow is measured in ml/100 grams/minute. The interpretation is that blood flow to that area indicates that region of the brain is responding to the visual alcohol or non-alcoholic beverage cues. Change in blood flow will be calculated as the change (and slope) of measurements taken at 10, 20, 30 and 45 minutes during the procedure. | During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure. |
| Change in Cortisol | The units for cortisol are micrograms/deciliter and the interpretation is that amount has been released into the blood stream from the HPA axis in response to alcohol or alcohol cues. Change in Cortisol will be calculated by taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure. | Before Procedure to 125 minutes after the procedure. |
| Drinking Behavior in daily experience outside of laboratory | A smartphone app will be used to collect 4 surveys a day for 30 days after completion of both arms. Multilevel modeling will be used to analyze patterns of drinking over time. | Day after Procedure to 30 days after procedure. |
| Amount of Alcohol Consumed | After exposure to alcoholic beverage and non-alcoholic beverage visual cues, quantity of alcohol consumed in a free choice test will be measured in milliliters. | Immediately after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Alcohol Urges (AUQ) | The urge to consume alcohol will be measured using the Alcohol Urge Questionnaire (AUQ). The AUQ consists of 8 questions 8-56 total point distribution. The greater the total points, the greater the measured urge to consume alcohol. The change in alcohol urge will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara K Blaine, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University MRI Center | Auburn | Alabama | 36832 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37484196 | Derived | Blaine SK, Ridner CM, Campbell BR, Crone L, Claus ED, Wilson JR, West SN, McClanahan AJ, Siddiq AS, Layman IMP, Macatee R, Ansell EB, Robinson JL, Beck DT. IL-6, but not TNF-alpha, response to alcohol cues and acute consumption associated with neural cue reactivity, craving, and future drinking in binge drinkers. Brain Behav Immun Health. 2023 Jun 11;31:100645. doi: 10.1016/j.bbih.2023.100645. eCollection 2023 Aug. |
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HIPAA requirements prohibit sharing of individual data. De-identified group data will be available.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002408 | Catheters, Indwelling |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
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| Before Procedure to 125 minutes after the procedure. |
| Stress levels in daily experience outside of laboratory | A smartphone app will be used to collect 4 surveys a day for 30 days after completion of both arms. Multilevel modeling will be used to analyze subjective experience of stress over time. | Post follow-up procedure (30 days) |
| Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress | One sample of whole blood will be obtained and analyzed for genomic associations with other outcome measures. | Post follow up procedure (within 2 years after procedure) |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |