Neurobiological Responses in Alcoholism and Early Trauma

• ClinicalTrials.gov Identifier: NCT04128228
• Recruitment Status: Recruiting
• First Posted: October 16, 2019
• Last Update Posted: May 18, 2022
• Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Dongju Seo, PhD; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04128228
• Other Study ID Numbers: 2000024809; 1R01AA026844 ( U.S. NIH Grant/Contract )
• First Posted: October 16, 2019
• Last Update Posted: May 18, 2022
• Last Verified: May 2022

• 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:

Alcoholism; Wounds and Injuries; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders