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Neurobiological Responses in Alcoholism and Early Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128228
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Early Trauma Complications Behavioral: 8-week outpatient treatment Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Neurobiological Responses in Alcoholism and Early Trauma
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Alcohol use disorder
All patients with alcohol use disorder will receive the same 8 week outpatient treatment.
Behavioral: 8-week outpatient treatment
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.

No Intervention: Controls
Control participants with and without early trauma will receive baseline assessment and no outpatient treatment.



Primary Outcome Measures :
  1. Dynamic neural response [ Time Frame: baseline, after treatment (up to 8 weeks) ]
    Brain response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task using functional magnetic resonance imaging.

  2. Stress hormone response [ Time Frame: baseline, after treatment (up to 8 weeks) ]
    Cortisol response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task.

  3. Alcohol relapse [ Time Frame: up to 90 days ]
    Time to relapse (event based); the first day of drink during the follow-up period.


Secondary Outcome Measures :
  1. Alcohol use (frequency) [ Time Frame: up to 90 days ]
    The total number of days of alcohol use during the follow-up period.

  2. Alcohol use (quantity) [ Time Frame: up to 90 days ]
    The average amount of alcohol use per day during the follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128228


Contacts
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Contact: Dongju Seo 203-737-3361 dongju.seo@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06492
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Dongju Seo, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04128228    
Other Study ID Numbers: 2000024809
1R01AA026844 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Alcohol use disorder
Early trauma
fMRI
Stress hormone
Alcohol relapse
Additional relevant MeSH terms:
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Alcoholism
Wounds and Injuries
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders