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Clinical Trial Summary

Alcohol use disorder with early trauma is associated with clinical challenges, including high comorbid symptoms and relapse rates. To better understand this phenomenon, this study will examine the neurobiological mechanisms underlying the relationship between alcohol use disorder, early trauma, and the high relapse risk. The current study utilizes a multimodal neuroimaging technique combining brain and hypothalamic-pituitary-adrenal axis (HPA) measures within a prospective clinical outcome design.


Clinical Trial Description

The current study intends to recruit four groups matched in demographic characteristics (age, sex ratio, education years). These groups include individuals with alcohol use disorder (AUD) with and without a history of early trauma, as well as healthy controls with and without a history of early trauma. The study procedures involve functional magnetic resonance imaging (fMRI) scan(s), eight weeks of outpatient treatment, and a follow-up phase. During the fMRI session, all participants will engage in a well-validated sustained emotion provocation task, involving the viewing of stress, alcohol-cue, and neutral pictures, while concurrent collection of brain and stress hormone data takes place. Control participants will undergo a single fMRI session at baseline, whereas AUD participants will partake in two fMRI sessions before and after outpatient treatment. Following the scan(s), a prospective follow-up will be conducted to monitor stress, alcohol, and health-related behaviors, which involves face-to-face interviews at 14, 30, 90 days, alongside daily monitoring using a smartphone app. Control participants will be followed for 30 days, while AUD participants will be followed for 90 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04128228
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date October 3, 2019
Completion date September 8, 2023

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