New Haven, Connecticut 06492

  • Early Trauma Complications

Purpose:

Early trauma is associated with clinical challenges in treatment alcoholism, including complex clinical symptoms and higher relapse rates. To better understand this phenomena, this study will examine the neurobiological mechanisms underlying alcoholism, early trauma, and high relapse risk. The current study utilizes a multimodal neuroimaging technique combining brain and hypothalamic-pituitary-adrenal axis (HPA) measures in a prospective clinical outcome design.


Study summary:

The current study will recruit four demographically-matched groups (total N=160; N=40 each; equal gender) including alcohol use disorder (AUD) patients with and without early trauma, and healthy controls with and without early trauma. General study procedures include functional magnetic resonance imaging (fMRI) scan(s), eight weeks of outpatient treatment, and a follow-up phase. During the fMRI session, participants will engage in a task involving the viewing of stress, alcohol, neutral pictures using a well-validated sustained emotion provocation task, while their brain and stress hormone data are concurrently collected. Controls will participate in a single fMRI session at baseline, and AUD patients will participate in two fMRI sessions before and after outpatient treatment. Subsequently after the scan(s), all participants will be prospectively followed for daily monitoring of stress, alcohol, and health related behaviors using a smartphone app. Controls will be followed for 30 days. AUD patients will be followed for 90 days, which includes face-to-face interviews at 14, 30, 90 days in addition to daily monitoring using a mobile app.


Criteria:

AUD inclusion Criteria: - Alcohol use disorder - Either low or high early trauma (based on the Childhood Trauma Questionnaire) - Body mass index (BMI) up to 35 (due to weight limitations of the MRI scanner) AUD exclusion Criteria: - Current or past substance use disorder other than alcohol; excluding caffeine and nicotine - Psychiatric disorders except for mood and anxiety disorders - Any significant current medical conditions - Women who are peri- and post- menopausal, pregnant or lactating - MRI specific exclusion criteria (e.g., claustrophobia, implanted metal in the body)


NCT ID:

NCT04128228


Primary Contact:

Principal Investigator
Dongju Seo, PhD
Yale University

Dongju Seo
Phone: 203-737-3361
Email: dongju.seo@yale.edu


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06492
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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