- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412824
Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Alabama
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Auburn, Alabama, United States, 36832
- Auburn University MRI Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
- Able to read and write English.
- Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1-3 drinks per occasion, 1-3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
- Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder
- Provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
- Body Mass Index between 20-35.
- No current or former nicotine dependence.
Exclusion Criteria:
- Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
- Current or past history of alcohol dependence or abuse.
- Any current use of opiates or past history of opiate abuse/dependence.
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Peri and post-menopausal women, and those with hysterectomies.
- Pregnant and lactating women will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Alcohol Beverage Cues
Participants will complete an MRI with alcohol beverage visual cues and oral alcohol session.
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In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
Other Names:
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Placebo Comparator: Non-Alcoholic Beverage Cues
Participants will complete an MRI with non-alcoholic beverage cues and oral alcohol session.
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In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neural Blood Flow
Time Frame: During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.
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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.
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During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.
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Change in Cortisol
Time Frame: Before Procedure to 125 minutes after the procedure.
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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.
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Before Procedure to 125 minutes after the procedure.
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Drinking Behavior in daily experience outside of laboratory
Time Frame: Day after Procedure to 30 days after procedure.
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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.
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Day after Procedure to 30 days after procedure.
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Amount of Alcohol Consumed
Time Frame: Immediately after the procedure.
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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.
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Immediately after the procedure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Alcohol Urges (AUQ)
Time Frame: Before Procedure to 125 minutes after the procedure.
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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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Before Procedure to 125 minutes after the procedure.
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Stress levels in daily experience outside of laboratory
Time Frame: Post follow-up procedure (30 days)
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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.
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Post follow-up procedure (30 days)
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Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress
Time Frame: Post follow up procedure (within 2 years after procedure)
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One sample of whole blood will be obtained and analyzed for genomic associations with other outcome measures.
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Post follow up procedure (within 2 years after procedure)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara K Blaine, PhD, Auburn University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-263 MR 1907
- R00AA025401 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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