Clinical trial NCT04412824: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-06-02
Enrollment: 87
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Neural Blood Flow
timeFrame: During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.
measure: Change in Cortisol
timeFrame: Before Procedure to 125 minutes after the procedure.
measure: Drinking Behavior in daily experience outside of laboratory
timeFrame: Day after Procedure to 30 days after procedure.
measure: Amount of Alcohol Consumed
timeFrame: Immediately after the procedure.
Secondary outcomes:
measure: Changes in Alcohol Urges (AUQ)
timeFrame: Before Procedure to 125 minutes after the procedure.
measure: Stress levels in daily experience outside of laboratory
timeFrame: Post follow-up procedure (30 days)
measure: Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress
timeFrame: Post follow up procedure (within 2 years after procedure)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University MRI Center
state: Alabama
Study officials:
affiliation: Auburn University
name: Sara K Blaine, PhD
role: PRINCIPAL_INVESTIGATOR
References: