Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation

Auburn University

Status and phase

Completed

Early Phase 1

Conditions

Alcohol Use Disorder

Treatments

Drug: Intravenous blood draw

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04412824

R00AA025401 (U.S. NIH Grant/Contract)

19-263 MR 1907

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.