Back to resultsMultimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous blood draw
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder
Eligibility Criteria
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.
Sites / Locations
- Auburn University MRI Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Alcohol Beverage Cues
Non-Alcoholic Beverage Cues
Arm Description
Participants will complete an MRI with alcohol beverage visual cues and oral alcohol session.
Participants will complete an MRI with non-alcoholic beverage cues and oral alcohol session.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04412824
First Posted
May 24, 2020
Last Updated
March 19, 2022
Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04412824
Brief Title
Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
Official Title
Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Beverage Cues
Arm Type
Active Comparator
Arm Description
Participants will complete an MRI with alcohol beverage visual cues and oral alcohol session.
Arm Title
Non-Alcoholic Beverage Cues
Arm Type
Placebo Comparator
Arm Description
Participants will complete an MRI with non-alcoholic beverage cues and oral alcohol session.
Intervention Type
Drug
Intervention Name(s)
Intravenous blood draw
Other Intervention Name(s)
Indwelling catheter for blood draws
Intervention Description
In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
Primary Outcome Measure Information:
Title
Change in Neural Blood Flow
Description
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.
Time Frame
During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.
Title
Change in Cortisol
Description
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.
Time Frame
Before Procedure to 125 minutes after the procedure.
Title
Drinking Behavior in daily experience outside of laboratory
Description
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.
Time Frame
Day after Procedure to 30 days after procedure.
Title
Amount of Alcohol Consumed
Description
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.
Time Frame
Immediately after the procedure.
Secondary Outcome Measure Information:
Title
Changes in Alcohol Urges (AUQ)
Description
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.
Time Frame
Before Procedure to 125 minutes after the procedure.
Title
Stress levels in daily experience outside of laboratory
Description
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.
Time Frame
Post follow-up procedure (30 days)
Title
Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress
Description
One sample of whole blood will be obtained and analyzed for genomic associations with other outcome measures.
Time Frame
Post follow up procedure (within 2 years after procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara K Blaine, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University MRI Center
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36832
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
HIPAA requirements prohibit sharing of individual data. De-identified group data will be available.
Learn more about this trial
Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
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