Neurobiological Responses in Alcoholism and Early Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neurobiological Responses in Alcoholism and Early Trauma

Conditions
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Alcohol Use Disorder, Early Trauma Complications

Intervention / Treatment
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* Behavioral: 8-week outpatient treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patents will receive the same 8-week outpatient treatment and the effects of intervention will be assessed before and after the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alcohol use disorder<br>All patients with alcohol use disorder will receive the same 8 week outpatient treatment. | Behavioral: 8-week outpatient treatment<br>* All patients will receive outpatient treatment for alcohol use disorder for 8 weeks. There will be two appointments each week for individual therapy sessions using cognitive behavioral therapy combined with stress management.<br>|
| No Intervention: Controls<br>Control participants with and without early trauma will receive baseline assessment and no outpatient treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic neural response | Brain response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task using functional magnetic resonance imaging. | baseline, after treatment (up to 8 weeks) | 
| Stress hormone response | Cortisol response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task. | baseline, after treatment (up to 8 weeks) | 
| Alcohol relapse | Time to relapse (event based); the first day of drink during the follow-up period. | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol use (frequency) | The total number of days of alcohol use during the follow-up period. | up to 90 days | 
| Alcohol use (quantity) | The average amount of alcohol use per day during the follow-up period. | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol use disorder, Early trauma, fMRI, Stress hormone, Alcohol relapse