NCT04412824

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Auburn University · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Intravenous blood draw	In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session

Timeline

• Start date: 2020-05-22
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-06-02
• Last updated: 2022-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study